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DAQSTATIONDXAdvanced Advanced Security FunctionsWhite Paper for FDA 21 CFR Part 11

TI 04L41B01-03E

TI 04L41B01-03E©Copyright Feb. 2010(KP)1st Edition Feb. 2010(KP)

All Rights Reserved. Copyright © 2010, Yokogawa Electric Corporation TI04L41B01-03E

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Overview of 21 CFR Part 1121 CFR§ 11, the FDA’s final rule on Electronic Records and Electronic Signatures, (Part 11) wasdeveloped in part in response to industry demand and in part as a result of regulations requiringgovernment agencies to implement policies to reduce the amount of paperwork both reviewedand stored in archives. Promulgated in August, 1997, Part 11 provides the criteria under which theFDA will consider electronic records and signatures to be equivalent to conventional paperrecords and handwritten signatures.

Comparison of Paper-Based Controls with Requirements for Electronic Records under 21 CFR § 11:Just as there are requirements for paper-based systems to assure that records are maintained ina secure form, protected from unauthorized changes and physical deterioration, Part 11 providescontrols to assure that electronic records can be maintained in the same way. Just as in apaper-based system changes may not obliterate the original entry, changes made to an electronicrecord may not obscure the original. In a paper-based system, all changes must be attributable toan individual, and in an electronic record system all changes made must be recorded in an audittrail that traces those changes back to an authorized user of the system. Physical securitycontrols must be in place to prevent unauthorized access to both paper-based and electronicrecords, and additional logical security procedures must be implemented to further protectelectronic records from unauthorized access.

Requirements for record archives are the same in both paper-based and electronic recordsystems. Both must be maintained in such a manner that they can be retrieved for the duration ofthe required storage period.

Electronic signatures applied to electronic records and conventional handwritten signaturesapplied to electronic records are recognized by the FDA as having the same legal authority asconventional handwritten signatures applied to paper records. Thus, appropriate controls areneeded over signatures that are applied to electronic records to assure that they cannot be forgedor copied to a different record. Additionally, it is necessary to provide a means of verifying, duringany routine review or inspection, that an electronic record has been signed in the same way that asigned paper record provides immediate proof that it has been signed by virtue of the prominentlydisplayed signature.

Part 11 also requires organizations and individuals utilizing electronic records and/or electronicsignatures to implement procedural controls to assure that affected personnel are appropriatelytrained and that all policies surrounding these records are properly documented.

Scope and Enforcement of 21 CFR § 11

While Part 11 is mandatory and not merely guidance from the FDA, it applies only to records inelectronic form that are created, modified, maintained, archived, retrieved, or transmitted underrecords requirements set forth in FDA regulations. The scope of the regulation covers bothelectronic records that will be submitted to the FDA and electronic records that are being kept tomeet an FDA regulatory requirement even if they will not be directly submitted to the FDA.

Records that are maintained by a company, but not required to comply with any FDA regulation donot need to comply with Part 11.

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Industry Support to Comply with the RegulationVarious support industries, such as those manufacturing automated laboratory instruments, areassisting regulated industries in achieving compliance by developing new and upgraded systemsthat include the logical controls needed to assure security and traceability of electronic recordsthroughout the record’s life-cycle. Yokogawa is one such company. Yokogawa has remainedcommitted to providing the highest quality solutions and leading edge technologies in the fields ofindustrial automation, and test and measurement.

Yokogawa has recently undertaken a major revision and upgrade of its DAQSTATIONDXAdvanced paperless recorders to provide features designed to meet the requirements of Part11 for enhanced security and traceability of electronic records. The DXAdvanced with AdvancedSecurity Functions (DXAdv/AS1) paperless recorders can be used in conjunction with anorganization’s own internal procedures to achieve full compliance with Part 11. Throughout thisdocument, requirements that cannot be met solely by the automated system but also requireinternal procedural controls are inserted into sections titled “Administrative Alert/ProceduralControl.” At the end of this document, the text of Part 11 is incorporated into a summary table thatcan be used as a quick reference to determine compliance to specific sections of the regulation.

The DXAdv/AS1 paperless recorders are designed to function independently to collect data froma variety of applications. They will integrate effectively into any environment in which conventionalchart recorders are currently used. These versatile recorders can collect and integrate data fromup to 48 individual input channels that can be individually, with an option of an additional 60calculation channels. Data can be transferred to a secure directory on a company’s network forfurther review via the DAQSTANDARD software, and also for archival and backups. Additionally, itis now possible for an appropriately authorized administrator to remotely configure the DXAdv/AS1 using the DAQSTANDARD software's communicator module. Real-time data can be viewedremotely through a web interface, thus allowing closer monitoring and control of processeswithout the need to travel to a remote production floor .

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Overview of 21 CFR Part 11 Requirements and theirIncorporation into the Features of the DAQSTATIONDX1000/DX2000 Advanced Security Functions (/AS1):

Logical Security

Part 11 requires that access to systems that are used to create, modify, maintain, or retrieveelectronic records to meet FDA requirements must be limited to authorized individuals.Additionally, authority checks are required to assure that authorized individuals accessing thesystems are able to perform only tasks for which they have the appropriate level of access and forwhich they have been properly trained. (21 CFR 11.10(d), (g), (i))

The DXAdv/AS1 paperless recorder can be configured to utilize a three-way combination of username, user identification codes (user IDs), and password or a two-way combination of user name,and password to limit system access only to authorized users. Each user name must be unique,as must each combination of user ID and password. Permissions can be further defined toprovide a variety of access levels ranging from view-only access to full administrative and remotecommunication and configuration rights.

The DXAdv/AS1 allows the configuration of a maximum of five (5) administrators and up to ninety(90) current users. Individual users cannot modify their own access levels.

This security is maintained throughout the lifecycle of the electronic records in that the userpermission and security data are directly linked to the associated acquired data files even whentransferred via FTP, External memory, or other means to a more permanent storage location.

Administrative Alert/Procedural Control: Each user must be properly trained to perform theirassigned tasks. That training should be according to approved and available written policiesand SOPs and must be documented. Training must encompass both the routine functions ofthe instrument and additional requirements imposed by the electronic nature of the data,including security. (21 CFR 11.10 (i) )

Additional security is required when user name/user IDs and password combinations are used toapply electronic signatures to assure that these cannot be copied or used by anyone other thantheir genuine owners. To assure continued security of user name/user ID/password combinations,identification codes and passwords must be periodically checked, recalled, or revised. (21 CFR11.200(a)(2); 11.300(a), (b))

The DXAdv/AS1 can be configured to use a combination of user name, user ID, and password toapply an electronic signature. While the user names and IDs can be viewed by administrators,passwords are stored encrypted and cannot be viewed by anyone, including administrators. Whena user account is initially configured by an administrator, the password is set to a default pre-expired password for that user level. Upon initial login, and before gaining access to any functionson the DXAdv/AS1, the user is immediately prompted to change the password. The DXAdv/AS1requires entry of a minimum of 6 and a maximum of 20 alphanumeric characters or symbols.Empty spaces or null values are not allowed, and the password is case-sensitive. If required bycompany polices, the administrator can configure a user's password to periodically expire at 1-month, 3-months, or 6-month intervals.

Limiting system access to only authorized users and controlling individual levels of accessprovides effective security during periods of routine use of the instrument. Part 11 requiresadditionally that records be protected so that they can be retrieved readily and accuratelythroughout any required retention period. This requirement applies not only to records at their timeof creation but also to archived electronic records for the duration of their storage period. (21 CFR11.10(c))

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An FTP client mode function allows records created by the DXAdv/AS1 to be automatically sentto a secure FTP server directory for long-term or short-term storage. The DXAdv/AS1 itself hasthe capability of automatically sending a preconfigured username and password combination, ifrequired, for file upload access to the FTP directory. Access levels at the FTP server, directorycan be further controlled through good local network security policies. Neither the DXAdv/AS1 northe DAQSTANDARD software allow a user to overwrite records. Data files are stored sequentiallyto the DXAdv/AS1 archive media (CF card) and then to the FTP server, when this function isused, so the data record is always archived even if a network connection to the server is lost. If theconnection fails, data will be automatically transferred via FTP as soon as the connection isrestored. These records can then be maintained under a company’s general electronic recordsarchive policies.

Administrative Alert/Procedural Control: The DXAdv/AS1 includes a FIFO (first-in-first-out)local data storage option that will automatically overwrite old data files on the local storagemedium after the medium become full. If the local storage medium will be used for primarydata storage, it is recommended that this feature be set to “Off” to assure proper long-termmaintenance of critical electronic records.

Record Traceability and Audit Trails

As in paper-based systems, where changes made to records may not obliterate the original entry,changes made to electronic records also may not obscure previously recorded information. Asecure, computer generated audit trail that automatically records the date and time of all operatorentries and actions that create, modify, or delete electronic records serves to meet this require-ment under Part 11. The FDA further clarified this requirement in the preamble to the regulation(FR vol. 62, No. 54, 3/20/97) where it described the intent of the audit trail as providing “a record ofessentially who did what, wrote what, and when.” The audit trail requirement under the regulationis designed to cover only those actions initiated by a person, not nonhuman background record-ings made by an instrument or software application independent of operator input. Additionally,the audit trail needs to record all actions that change an electronic record in any way, but does notneed to record user actions, such as switching among screen displays, that would have no effecton the content of electronic records. (21 CFR 11.10(e))

It is important not only to track changes made to acquired data such as temperature readings butalso to track operator actions such as activating a manufacturing sequence or turning off analarm. Because the FDA is interested in being able to reproduce and verify the process underwhich data were acquired, any modification that would change the final result should also betracked via an audit trail. This might include changes to calculations, calibration methods, or alarmsettings. Because changes to user security settings could have a significant effect on the validityof data, these should also be traceable to the individual making the change and the date and timeof the change. Such data can be loosely grouped under the term metadata.

Regardless of the mode of access or modification, the DXAdv/AS1 maintains records of allalarms, alarm acknowledgements, error messages (including unauthorized attempts at access),changes to configuration and calculation settings, and current user authorization levels in binaryfiles.

These files can be viewed through the DAQSTANDARD software but cannot be changed by usersor administrators. Acquired data, such as temperature values, are also stored in a proprietarybinary format and cannot be changed once they have been stored. Should a user attempt tochange any data by directly accessing the binary data, the file will become useless to the user. Anerror message will appear the next time anyone attempts to access the data notifying the userthat the data has been changed and the file cannot be viewed.

Administrative Alert/Procedural Control: Procedures for backups and archives must bedeveloped and implemented to assure that accurate copies of all data are securelymaintained and can be retrieved for the entire required storage period. (21 CFR 11.10(b), (c))

The audit trail must be capable of being copied and available for review for the required storageperiod of the associated electronic record. (21 CFR 11.10(e))

Each log created by the DXAdv/AS1 is linked to the next data file created after the change. Thelogs are copied automatically whenever the original data file is copied, and they are transferred tothe FTP server for long-term storage along with the associated data file.

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Validation

Systems used to create, modify, and maintain electronic records must be validated to ensureaccuracy, reliability, consistent intended performance and the ability to discern invalid or alteredrecords. (21 CFR 11.10(a))

While a significant amount of verification testing can be performed by the factory, to fully complywith agency expectations, validation of systems must be performed in their actual workingenvironment. Therefore, no vendor can truly make a claim that any system has been fully vali-dated for use in an FDA regulated environment. However, because each user will merely bechoosing from a set list of functionality available with the DXAdv/AS1, it is possible to prepareboth Installation/Configuration/Function verification protocols that can be completed by each userto meet their own specific requirements for functionality. Yokogawa is providing an Installation/Configuration/Function verification template at additional cost that can be used in conjunction withan end user’s own operational policies and procedures to meet the requirements for validation ofthis system.

Record Maintenance

Part 11 requires that electronic records be protected to enable accurate and ready retrievalthroughout their retention period. Additionally, it must be possible to make both electronic andhuman readable copies that are suitable for inspection, review, and copying by the FDA. Thecopies must be accurate and complete so that it will be possible to create a virtual reproduction ofthe processes contributing to the original creation of the records. (21CFR 11.10(b))

Key to this requirement is the concept of metadata, or data about data. Metadata are those data inaddition to the acquired results or measurements that determine the environment in which theacquired data are collected. In the environment of the DXAdv/AS1 this includes, but is not limitedto, information such as the actual identification make and model of the DXAdv/AS1 used tocollect the data, input channel settings, calibration settings, alarm settings, calculations pro-grammed into the math channels, user access levels, units of measurement, thermocouple types(collectively referred to as system settings), and dates and times of “start” and “stop” commands.

Metadata are stored completely in dedicated configuration files, and then copied into the nextdata file at the start of a run. This is the electronic audit trail data for the DXAdv/AS1. Because thisinformation is automatically saved with the batch data files, maintenance of the metadata occursnaturally if the batch records are maintained.

Final secure maintenance of all DXAdv/AS1 data can be further enhanced by using the FTP clientmode feature. The DXAdv/AS1 can transfer data files automatically to a secure network server.Primary and secondary servers can be specified. Files automatically transfer to the secondaryserver only if connection to the primary sever fails. When FTP client mode is used, the data file(including all audit trail data) is saved to both the archive media (CF card) and the server at thesame time. Either location can be selected to serve as a master user copy, backup, or finalarchive. Various possible usage options are as follows:

Option 1: On memory stop action (end of data file/batch record) the instrument is configured tostore the data to the archive media and to send a backup copy via FTP to a networkserver. Electronic signatures can be applied by DAQSTANDARD software to the filestored on the portable archive media. The same access security measures apply forboth the DXAdv/AS1 and DAQSTANDARD software under all conditions. With eachmodification of the locally stored media, an updated backup file is sent to the server viaFTP. These backup files can be maintained and archived in accordance with acompany’s established network backup procedures.

Administrative Alert/Procedural Control: Data collected in Batch mode where more than onefile comprise a batch, may only be signed using the DAQSTANDARD software. This isdescribed further under Electronic Signature Implementation in this document.

Option 2: The DXAdv/AS1 is used in a completely stand-alone mode without using the FTPtransfer feature. All data are stored to the internal memory and portable archive media.Data that is stored to the internal memory may serve as the master data and data that isstored to the archive media may serve as the master copy and ultimately the finalarchive. Records can be reviewed and signed later using the DXAdv/AS1 or the

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DAQSTANDARD software by retrieving the appropriate file. Under this scenario, only asingle working copy of each data file is available, and all modifications are applied to thesame file, Backups can be performed through the company’s routine backup policies.

Administrative Alert/Procedural Control: Procedures, such as those governing creation ofbackups and archives, must be developed to assure that all electronic records are adequatelyprotected throughout the required record retention period. (21 CFR 11.10(c))

Records maintained by the DXAdv/AS1 and the DAQSTANDARD software are stored in a mediaformat that can be easily copied for backups and archiving. Records can be securely stored in anetwork directory or other area with controlled access and then archived through a company’sroutine procedures to be readily available for inspection and copying for regulatory officials. Datacreated and stored by the DXAdv/AS1 can be viewed only through the Yokogawa software, eitherlocally at the DXAdv/AS1 or remotely through the DAQSTANDARD software.

Administrative Alert/Procedural Control: Company change control, backup, archive, anddisaster recovery policies should be sure to encompass both the DXAdv/AS1 data files andthe DAQSTANDARD software, if used.

Additional Controls for Open Systems

Part 11 acknowledges two basic categories of electronic record keeping systems, open andclosed. A closed system is defined as an environment in which system access is controlled by thesame persons responsible for the content of the electronic records maintained on that system. Anopen system is one in which system access is controlled by persons other than those responsiblefor the content of the records maintained on that system. Examples of closed systems include astand-alone PC or a company’s local network. An example of an open system is a system thatmay be accessed through an outside internet service provider. Because of the increased risk todata integrity and confidentiality when sent through an open system, Part 11 requires additionalcontrols over that data that may include document encryption, or digital signatures.

The DXAdv/AS1 functions as a stand-alone instrument and does not allow a user to accesslocally stored data remotely, nor can data be acquired anywhere other than at the local DXAdv/AS1 station. The DXAdv/AS1 status can be viewed remotely through Microsoft Internet Explorerbut electronic data cannot be changed through this route. Remote configuration features avail-able through the DAQSTANDARD software function only within the parameters of a company'slocal network.Thus, the DXAdv/AS1 functions as a closed system with system access controlledby the same people responsible for the content of the associated electronic records, and addi-tional security requirements for open systems as defined in Part 11 are not applicable. TheDAQSTANDARD software can be used to access data that has been transferred to a networkdirectory via FTP for reviewing and signing provided a user has been provided with sufficientaccess rights. The DAQSTANDARD software must be individually installed onto each PC onwhich it is used. If access to the company’s network is controlled by the company, there are noadditional concerns related to open systems associated with the DXAdv/AS1. (21 CFR 11.30)

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Electronic Signature Security and ManifestationRequirements

Criteria have been set forth in Part 11 whic h, when met, will assure that electronic signaturesapplied to electronic records possess all characteristics necessary to be considered the legalequivalent of conventional handwritten signatures applied to paper records. Measures must betaken to assure that electronic signatures cannot be copied or forged through conventional meansof electronic data manipulation.

Additionally, logical security features must be established to assure that electronic signaturescannot be applied by anyone other than their actual owners and can be traced unambiguously toa single individual. (21 CFR 11.70; 11.200(a)(2), (3); 11.300(a))

Administrative Alert/Procedural Control: Before an organization may begin using electronicsignatures, they must submit a signed statement to the FDA certifying that the electronicsignatures in their system are intended to be the legally binding equivalent of traditionalhandwritten signatures. This certification must be submitted in paper form and may besubmitted globally to cover all electronic signatures for the entire organization. Additionalcertification of individual electronic signatures must be submitted upon agency request.(21 CFR 11.100(c))

Required controls for electronic signatures vary depending upon the type of signature beingapplied. Signatures that are based solely on a series of keystrokes, such as a combination of userID and password, require controls such as periodic password expiration to assure that theycontinue to be available only to the authorized user. Electronic signatures that involve a combina-tion of keystrokes and use of a device or token require loss management controls and periodicperformance checks to assure that they have not been tampered with. Additionally, these cannotbe based solely upon a single element such as a swipe of a token or card, but must be combinedwith additional controls such as password entry or other feature to assure that, if stolen, theycannot be used by an unauthorized person. Electronic signatures based on biometrics, such asfingerprints or voice scans, are clearly the most secure form. However, these must be carefullydesigned to assure that they cannot be used by anyone other than their genuine owner. Whenfully compliant and secure, this type of electronic signature does not require a secondary confir-mation such as a password. (21 CFR 11.300(b), (c); 11.200(b))

Electronic Signature Implementation in the DXADV/AS1

The DXAdv/AS1 recorders allow the application of electronic signatures that utilize a combinationof the user’s name, user ID, and password. Up to three (3) electronic signatures can be affixed toa data file, and each user is assigned an individual signature slot (Signature 1, Signature 2,Signature 3, or no signature authority) at the time of configuration. Users may only sign a record iftheir allotted slot has not already been filled. An administrator may sign in any signature positionthat has not been previously filled by another’s signature.

The DXAdv/AS1 can be operated in either Batch or Continuous modes for data collection. InBatch mode, the DXAdv/AS1 will generally create a single file or batch record, the length of whichis determined by start and stop control actions. In this mode, signatures may be applied directlyat the DXAdv/AS1 station, or with the DAQSTANDARD software during later record review on acomputer. However, it is possible for a batch record to consist of multiple files saved in sequenceover a long time period. In this case, signatures may only be applied with the DAQSTANDARDsoftware during later record review. The DAQSTANDARD software automatically links multiplefiles together within a batch and applies signature information to each file.

In Continuous mode, each data file is its own discrete entity. Signatures can be applied either atthe DXAdv/AS1 station or with the DAQSTANDARD software. Electronic signatures affixed to datacollected in Continuous mode apply only to a single data file, not to an entire batch. And signa-tures can be applied to combined data file at the DAQSTANDARD software.

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General Requirements for all Electronic Signatures

Each electronic signature must be uniquely traceable to a single individual and may not bere-used or reassigned to anyone else. (21 CFR 11.200(a)(2), (b))

The DXAdv/AS1 can store up to five (5) current administrative level and ninety (90) current userlevel ID combinations. It is not possible to duplicate user name and /or User ID and passwordcombinations, thus each electronic signature will be uniquely traceable to a single individual.

Administrative Alert/Procedural Control: Written policies must be established holdingindividuals using electronic signatures accountable and responsible for actions initiated undertheir electronic signatures. Internal training should emphasize the possible consequences ofusing another person’s identification information and of sharing identification and passwordcombinations with others. Additionally, a company is required to verify an individual’s identitybefore authorizing them to use electronic signatures. This procedure can be easilyincorporated into most human resources policies. (21 CFR 11.10(j); 11.100(b))

Electronic signatures that are not based on biometrics must use at least two distinct components.Examples are electronic signatures that utilize a combination of a User ID and password, orelectronic signatures comprised of a swipe card plus password combination. One of thosecomponents must be executable only by the authorized user. When a user applies a series ofelectronic signatures during a single session of continuous controlled access, the initial signingmust employ all of the electronic signature components. Subsequent signings during that sameperiod of controlled access must employ the component that is executable only by the individual. Ifone or more signings are not performed during a single session of continuous controlled access,each component of the electronic signature must be applied each time. (21 CFR 11.200(a))

At its highest security level, the DXAdv/AS1 utilizes a three-way combination of User Name, UserID, and password to allow routine user access. The electronic signature process automaticallyapplies the user’s name to the record after they have correctly entered their User ID and pass-word. The password component is stored encrypted and is not available for viewing by anyone.Each electronic signature requires the user to reenter both the User ID and the password, thusthere are no issues related to continuous versus non-continuous controlled access when operat-ing the DXAdv/AS1. Signature application through the DAQSTANDARD software includes thesame components and controls.

Electronic signatures must be administered and executed to assure that attempted use of anindividual’s electronic signature by anyone other than its genuine owner requires collaboration oftwo or more individuals. (21 CFR 11.200(a)(3))

The password component of the user’s identification is stored in encrypted format and is notviewable to an administrator or other user.

Administrative Alert/Procedural Control: In addition to the current alpha-numeric keypad,Yokogawa has developed a remote input device that provides additional flexibility and securitywhen entering passwords, user IDs, and textual comments. And USB keyboard is alsoavailable when entering textual comments.

As with all systems using passwords, users should be careful not to enter their privatesecurity codes when other personnel are watching.

Signature Manifestations

The printed name of the signer, the date and time of signing, and the meaning of the signing mustbe included as part of any human readable form of the electronic record. This includes both paperand electronic displays. The electronic signatures must be linked to their respective electronicrecords so that they cannot be removed, copied or transferred in any other way using ordinarymeans of record manipulation. (21 CFR 11.50, 70)

Before affixing an electronic signature to a data set, an authorized user is required to log onto theDXAdv/AS1 or DAQSTANDARD software. The user name as originally entered is automaticallyapplied to the electronic signature. The date and time of signing are automatically saved alongwith the signature. Calendar functions in the DXAdv/AS1 can only be changed by an authorizedadministrator or authorized user, not by a routine user. When a user electronically signs a DXAdv/

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AS1 data file, they are prompted to choose either “Pass” or “Fail” as a meaning of that signatureand have the option of entering additional comments via the alphanumeric keypad. Electronicsignatures applied to records created by the DXAdv/AS1 cannot be removed after they have beenapplied. DXAdv/AS1 data files are stored in a proprietary binary format so that they cannot bemodified by ordinary means once they have been created. This applies equally to the electronicsignatures. The actual signatures and all associated data can be viewed either at the DXAdv/AS1or through the DAQSTANDARD software.

Administrative Alert/Procedural Control: A fully compliant electronic signature in the DXAdv/AS1 environment requires that the full user’s name is entered into the User Name field whenthe user is initially configured for access to the recorder. There is no minimum number ofcharacters required in the User Name field, therefore this requirement should be specified ina company procedure to be sure that it is followed consistently.

Specific Controls for Identification Codes and Passwords

When used to apply electronic signatures, identification codes (user name and user ID) andpasswords must be periodically checked, recalled, or revised to ensure continued confidentiality.Additionally, transaction safeguards are required to assure that any unauthorized attempts at usewill be detected, reported, and prevented. It is insufficient to merely detect and report attempts atunauthorized use. The impostor must also be prevented from gaining access to the records forsigning. (21 CFR 11.300(b), (d))

User passwords can be configured to expire at 1, 3, or 6-month intervals in the DXAdv/AS1. Auser is not permitted to reenter the same password for more than one time-cycle. No user canelectronically sign a record without first logging onto the DXAdv/AS1 with an authorized username/password combination. At login, a user is permitted only three (3) or five (5) attempts toenter a correct User ID/password combination. After the third or fifith incorrect attempt, that user’saccess permissions are deactivated and notification, depending on the system’s configuration, issent. Following appropriate investigation, an administrator can acknowledge the warning mes-sage, re-set the user’s access permissions, and allow the actual owner of the signature to use theinstrument and electronically sign records.

Administrative Alert/Procedural Control: Routine password expirations should be specified inwritten procedures and then incorporated into the user configuration of the DXAdv/AS1.

Further security is provided at the actual signature application level. Following the third or fifithincorrect attempt to sign a record, that user’s signature permissions to that specific data file arepermanently deactivated. A warning message appears on the DXAdv/AS1 station screen. Anadministrator can reactivate the user for access to subsequent data and DXAdv/AS1 functions butcannot reactivate the user permissions to that specific batch. This allows the user’s signatureinformation to remain secure from tampering in both the DXAdv/AS1 and DAQSTANDARDsoftware environments. Should that individual absolutely need to sign that particular data file, aprinted report can be created that can be manually signed by any user.

Administrative Alert/Procedural Control: At least two administrators should be configured atall times. If an unauthorized attempt to use an administrator’s user information is detected,that administrator’s access permissions will be deactivated as with a routine user. Unlessanother administrator has been previously configured, no further administrative access to theunit will be allowed.

A permanent record of all notifications of unauthorized attempts at use and who acknowledgedand reset those messages is maintained as part of the DXAdv/AS1 audit trail records. Thus, ifthere is ever any question related to user access or signature applications, an administrator canreview that data to determine any needed corrective action.

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Other Procedural Controls

Documentation

Complete system documentation may include standard operating procedures, specifications andvalidation documents, training records, and any other company policy documents that applies tothe processes monitored by the DXAdv/AS1. This documentation may be paper-based orelectronic. Regardless of the media, appropriate controls over system documentation must beestablished to assure controlled distribution and revision and change control procedures. Revi-sion and change control procedures must include an audit trail that documents changes chrono-logically. (21 CFR 11.10(k))

The actual controls implemented will depend on a company’s specific documentation systems.Because documents are frequently stored and modified in electronic form but routinely accessedin either electronic or paper form, controls should encompass both types of media. Any associ-ated documentation meeting the definition of an electronic record must also be kept in a mannercompliant to Part 11. Access and revisions to paper documents pertaining to electronic recordssystems must still be controlled in accordance with Part 11.10(k).


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c k o

n ea

ch d

ata

file

to a

lert

the

user

if th

e da

ta fi

le

has

been

alte

red.

Ele

ctro

nic

sign

atur

es a

pplie

d us

ing

the

DX

Adv

/AS

1 or

DA

QS

TAN

DA

RD

sof

twar

e ca

nnot

be

rem

oved

. C

ontr

olle

d us

er a

cces

s pe

r mis

sion

s pr

even

t a

user

fro

m a

pply

ing

anyo

ne’s

ele

ctro

nic

sign

atur

e ot

her

than

thei

r ow

n.

Val

idat

ion

of

syst

ems

to

ensu

re

accu

racy

, re

liabi

lity,

co

nsis

tent

in

tend

ed

perf

orm

ance

, an

d th

e ab

ility

to

di

scer

n in

valid

or

alte

red

reco

rds.

21 C

FR

§ 1

1.10

(a)

An

optio

nal,

Inst

alla

tion/

Con

figur

atio

n/F

unct

ion

Ver

ifica

tion

pack

age

is p

rovi

ded

that

can

be

used

in

conj

unct

ion

with

an

end

user

’s o

wn

oper

atio

nal p

olic

ies

and

proc

edur

es t

o m

eet

the

requ

irem

ents

for

va

lidat

ion

of th

is s

yste

m.

The

abi

lity

to g

ener

ate

accu

rate

and

com

plet

e co

pies

of

reco

rds

in

both

hu

man

re

adab

le

and

elec

tron

ic

form

su

itabl

e fo

r in

spec

tion,

rev

iew

, and

cop

ying

by

the

agen

cy.

21 C

FR

§ 1

1.10

(b)

DX

Adv

/AS

1 D

ispl

ay a

nd E

vent

dat

a fil

es a

re s

tore

d in

a p

ropr

ieta

ry Y

okog

awa

bina

ry p

roto

col.

The

se

files

inc

lude

aud

it tr

ail

data

. Yok

ogaw

a V

iew

er s

oftw

are

disp

lays

and

prin

ts d

ata

in h

uman

rea

dabl

e fo

rm. T

he fi

les

can

be e

asily

cop

ied

for

back

ups,

arc

hivi

ng, i

nspe

ctio

n, a

nd r

evie

w.

Pro

tect

ion

of r

ecor

ds t

o en

able

the

ir ac

cura

te a

nd r

eady

re

trie

val t

hrou

ghou

t the

rec

ords

ret

entio

n pe

riod.

21 C

FR

§ 1

1.10

(c)

DX

Adv

/AS

1 st

orag

e m

edia

can

be

arch

ived

for

long

-ter

m s

tora

ge a

nd r

etrie

val,

or f

iles

can

be c

opie

d to

oth

er lo

ng-t

erm

arc

hive

med

ia s

uch

as C

DR

OM

. Vie

wer

sof

twar

e ca

n be

sto

red

on C

DR

OM

with

the

data

file

s to

ens

ure

long

-ter

m r

eten

tion

of c

ompa

tible

vie

win

g so

ftwar

e.T

here

are

no

avai

labl

e m

eans

to c

hang

e sa

ved

data

thro

ugh

the

DX

Adv

/AS

1 or

DA

QS

TAN

DA

RD

sof

twar

e.

Lim

iting

sys

tem

acc

ess

to a

utho

rized

indi

vidu

als.

21 C

FR

§11

.10

(d)

The

DX

Adv

/AS

1 su

ppor

ts a

thr

ee-le

vel

acce

ss a

utho

rizat

ion

feat

ure

usin

g U

ser

Nam

e, U

ser

ID,

and

Pas

swor

d.U

p to

thre

e (3

) A

dmin

istr

ator

s an

d ni

nety

(90

) U

sers

can

be

conf

igur

ed. A

dmin

istr

ator

s ha

ve a

cces

s to

al

l fun

ctio

ns a

nd m

enus

. Use

r ac

cess

per

mis

sion

s ca

n be

furt

her

defin

ed b

y th

e A

dmin

istr

ator

s.

Use

of

secu

re,

com

pute

r-ge

nera

ted,

tim

esta

mpe

d au

dit

trai

ls

to

inde

pend

ently

re

cord

th

e da

te

and

time

of

oper

ator

ent

ries

and

actio

ns t

hat

crea

te,

mod

ify,

or d

elet

e el

ectr

onic

rec

ords

. R

ecor

d ch

ange

s sh

all

not

obsc

ure

pre

vio

usl

y re

cord

ed

in

form

atio

n.

Su

ch

au

dit

tra

i l do

cum

enta

tion

shal

l be

reta

ined

for

a pe

riod

for

at le

ast a

s lo

ng a

s th

at r

equi

red

for

the

subj

ect e

lect

roni

c re

cord

s an

d sh

all b

e av

aila

ble

for

agen

cy r

evie

w a

nd c

opyi

ng.

21 C

FR

§ 1

1.10

(e)

The

DX

Adv

/AS

1 m

aint

ains

rec

ords

of a

ll al

arm

s, a

larm

ack

now

ledg

emen

ts, e

rror

mes

sage

s (in

clud

ing

unau

thor

ized

atte

mpt

s at

acc

ess)

, ch

ange

s to

con

figur

atio

n an

d ca

lcul

atio

n se

tting

s, a

nd c

urre

nt u

ser

auth

oriz

atio

n le

vels

in

bina

ry f

iles.

The

se f

iles

can

be v

iew

ed t

hrou

gh t

he D

AQ

STA

ND

AR

D s

oftw

are

but

cann

ot b

e ch

ange

d by

use

rs o

r ad

min

istr

ator

s. E

ach

log

crea

ted

by t

he D

XA

dv/A

S1

softw

are

is

linke

d to

the

nex

t da

ta f

ile c

reat

ed a

fter

the

chan

ge. T

he l

ogs

are

copi

ed a

utom

atic

ally

whe

neve

r th

e or

igin

al d

ata

file

is c

opie

d, a

nd t

hey

are

tran

sfer

red

to t

he F

TP

ser

ver

for

long

-ter

m s

tora

ge a

long

with

th

e as

soci

ated

dat

a fil

e.

YE

S

YE

S

YE

S

YE

S

YE

S

YE

S

Feb. 15, 2010-00


13Yo

kog

awa

DA

QS

TAT

ION

Ph

arm

aceu

tica

l Mo

del

DX

Adv

ance

d A

dvan

ced

Sec

uri

ty F

un

ctio

ns

21 C

FR

§ 1

1 C

om

plia

nce

Su

mm

ary

Tabl

e

Mee

t R

equ

irem

ent?

Co

ntr

ols

for

Clo

sed

Sys

tem

s

21 C

FR

§ 1

1 R

efer

ence

Co

mm

ents

NO

YE

S

Use

of

auth

ority

che

cks

to e

nsur

e th

at o

nly

auth

oriz

ed

indi

vidu

als

can

use

the

syst

em,

elec

tron

ical

ly

sign

a

reco

rd,

acce

ss t

he o

pera

tion

or c

ompu

ter

syst

em i

nput

or

outp

ut d

evic

e, a

lter

a re

cord

, or

per

f orm

the

ope

r atio

n at

ha

nd.

21 C

FR

§ 1

1.10

(g)

The

DX

Adv

/AS

1 su

ppor

ts t

wo

or t

hree

-leve

l ac

cess

aut

horiz

atio

n fe

atur

e us

ing

Use

r N

ame,

Use

r ID

(s

elec

tabl

e), a

nd P

assw

ord.

The

sam

e au

thor

ity c

heck

s ar

e ap

plie

d at

the

time

of e

lect

roni

c si

gnat

ure

affix

atio

n.

Use

of

devi

ce (

e.g.

, te

rmin

al)

chec

ks t

o de

term

ine,

as

appr

opri

ate,

th

e va

lidity

of

th

e so

urce

da

ta

inpu

t or

op

erat

iona

l ins

truc

tion.

21 C

FR

§ 1

1.10

(h)

The

DX

Adv

/AS

1 fu

nctio

ns a

s a

clos

ed s

yste

m t

hat

can

be c

onfig

ured

at

the

loca

l us

er i

nter

face

. A

cqui

red

DX

Adv

/AS

1 da

ta c

an b

e se

nt t

o a

net w

ork

dire

ctor

y vi

a a

one -

way

sec

ure

inte

rfac

e in

corp

orat

ing

avai

labl

e ne

twor

k se

curit

y fe

atur

es s

uch

as u

ser

ID a

nd p

assw

ord

verif

icat

ion.

Det

erm

inat

ion

that

per

sons

who

dev

elop

, m

aint

ain,

or

use

elec

tron

ic r

ecor

d/el

ectr

onic

sig

natu

re s

yste

ms

have

the

ed

ucat

ion,

tr

aini

ng,

and

expe

rien

ce

to

perf

orm

th

eir

assi

gned

task

s.21

CF

R §

11.

10 (

i)

Doc

umen

tatio

n of

tra

inin

g an

d us

er q

ualif

icat

ions

is

the

resp

onsi

bilit

y of

the

ind

ivid

ual

orga

niza

tion.

Yo

koga

wa

prov

ides

ope

ratin

g m

anua

ls f

or e

ach

DX

Adv

/AS

1 an

d th

e D

AQ

STA

ND

AR

D s

oftw

are

that

ca

n be

inco

rpor

ated

into

a c

ompa

ny’s

ow

n tr

aini

ng p

roce

dure

s.

The

est

ablis

hmen

t of

, an

d ad

here

nce

to,

writ

ten

polic

ies

that

ho

ld

indi

vidu

als

acco

unta

ble

and

resp

onsi

ble

for

actio

ns i

nitia

ted

unde

r th

eir

elec

tron

ic s

igna

ture

s, i

n or

der

to d

eter

rec

ord

and

sign

atur

e fa

lsifi

catio

n. 21 C

FR

§ 1

1.10

(j)

Wri

tten

po

licie

s ho

ldin

g in

divi

dual

s ac

coun

tabl

e fo

r ac

tions

pe

rfor

med

un

der

thei

r el

ectr

onic

si

gnat

ures

are

the

res

pons

ibili

ty o

f ea

ch c

ompa

ny.

The

DX

Adv

/AS

1 pr

ovid

es a

sec

ure

elec

tron

ic

sign

atur

e op

tion

the

will

faci

litat

e co

mpl

ianc

e in

con

junc

tion

with

a c

ompa

ny’s

inte

rnal

pro

cedu

res.

Use

of

oper

atio

nal

syst

em c

heck

s to

enf

orce

per

mitt

ed

sequ

enci

ng o

f ste

ps a

nd e

vent

s, a

s ap

prop

riate

.21

CF

R §

11.

10 (

f)

Dat

a ca

n be

rev

iew

ed a

nd s

igne

d on

ly a

fter

the

colle

ctio

n ha

s be

en s

topp

ed.

If a

data

set

is c

olle

cted

in a

bat

ch c

ompr

ised

of

mor

e th

an o

ne d

ata

file ,

tha

t da

ta c

an n

ot b

e si

gned

un

less

all

asso

ciat

ed fi

les

are

pres

ent.

Use

of

appr

opria

te c

ontr

ols

over

sys

tem

s do

cum

enta

tion

incl

udin

g:(1

) A

dequ

ate

cont

rols

ove

r th

e di

strib

utio

n of

, ac

cess

to,

an

d us

e of

doc

umen

tatio

n fo

r sy

stem

ope

ratio

n an

d m

aint

enan

ce.

(2)

Rev

isio

n an

d c-

hang

e co

ntro

l pro

cedu

res

to m

aint

ain

an

audi

t tr

ail t

hat

docu

men

ts t

ime-

sequ

ence

d de

velo

pmen

t an

d m

odifi

catio

n of

sys

tem

s do

cum

enta

tion.

21 C

FR

§ 1

1.10

(k)

Pro

cedu

res

for

prep

arat

ion

and

cont

rol

of d

ocum

enta

tion

mus

t be

est

ablis

hed

by e

ach

indi

vidu

al

com

pany

.N

/A

N/A

N/A

YE

S

YE

S

YE

S

Feb. 15, 2010-00


14Yo

kog

awa

DA

QS

TAT

ION

Ph

arm

aceu

tica

l Mo

del

DX

Adv

ance

d A

dvan

ced

Sec

uri

ty F

un

ctio

ns

21 C

FR

§ 1

1 C

om

plia

nce

Su

mm

ary

Tabl

e

Mee

t R

equ

irem

ent?

Co

ntr

ols

for

Op

en S

yste

ms

21 C

FR

§ 1

1 R

efer

ence

Co

mm

ents

NO

YE

S

Per

sons

who

use

ope

n sy

stem

s to

cre

ate,

mod

ify, m

aint

ain,

or

tran

smit

elec

tron

ic

reco

rds

shal

l em

plo y

pr

oced

ures

an

d co

ntro

ls

to

ensu

re

the

auth

entic

ity,

inte

grity

, an

d,

as

appr

opria

te,

the

conf

iden

tialit

y of

ele

ctro

nic

reco

rds

from

the

po

int

of t

heir

cre

atio

n to

the

poi

nt o

f th

eir

rece

ipt.

Suc

h pr

oced

ures

an

d co

ntro

ls

shal

l in

clud

e th

ose

iden

tifie

d in

§1

1.10

, as

app

ropr

iate

, an

d ad

ditio

nal

mea

sure

s su

ch a

s do

cum

ent

encr

yptio

n an

d us

e of

app

ropr

iate

dig

ital

sign

atur

e st

anda

rds

to e

nsur

e, a

s ne

cess

ary

unde

r th

e ci

rcum

stan

ces,

re

cord

aut

hent

icity

, int

egrit

y, a

nd c

onfid

entia

lity.

21 C

FR

§ 1

1.30

The

DX

Adv

/AS

1 is

a c

lose

d sy

stem

. Acc

ess

to r

ecor

ds is

con

trol

led

by t

he s

ame

pers

ons

resp

onsi

ble

for

the

cont

ent o

f tho

se r

ecor

ds.

Sig

ned

elec

tron

ic r

ecor

ds s

hall

cont

ain

info

rmat

ion

asso

ciat

ed

with

the

sign

ing

that

cle

arly

indi

cate

s al

l of t

he fo

llow

ing:

The

prin

ted

nam

e of

the

sign

er;

The

dat

e an

d tim

e w

hen

the

sign

atur

e w

as e

xecu

ted;

and

The

mea

ning

(su

ch a

s re

view

, ap

prov

al,

resp

onsi

bilit

y, o

r au

thor

ship

) as

soci

ated

with

the

sign

atur

e.

The

ite

ms

iden

tifie

d [a

bove

] sh

all

be s

ubje

ct t

o th

e sa

me

cont

rols

as

for

elec

tron

ic r

ecor

ds a

nd s

hall

be in

clud

ed a

s pa

rt

of a

ny h

uman

rea

dabl

e fo

rm o

f th

e el

ectr

onic

rec

ord

(suc

h as

el

ectr

onic

dis

play

or

prin

tout

).21

CF

R §

11.

50

The

use

r na

me,

and

dat

e an

d tim

e of

sig

ning

are

aut

omat

ical

ly l

inke

d to

the

sig

ned

reco

rd w

hen

the

sign

atur

e is

affi

xed.

The

use

r m

ust

choo

se e

ither

“P

ass”

or

“Fai

l” an

d ha

s th

e ad

ditio

nal

optio

n of

en

terin

g a

cust

omiz

ed te

xt m

essa

ge fo

r ea

ch s

igna

ture

. The

ele

ctro

nic

sign

atur

e is

link

ed to

the

reco

rd

and

can

not

be d

elet

ed. A

ll in

form

atio

n as

soci

ated

with

the

ele

ctro

nic

sign

atur

e is

ava

ilabl

e fo

r re

view

bo

th a

t the

DX

Adv

/AS

1 an

d th

roug

h th

e D

AQ

STA

ND

AR

D s

oftw

are

via

elec

tron

ic d

ispl

ay o

r pr

into

ut.

Ele

ctro

nic

sign

atur

es a

nd h

andw

ritte

n si

gnat

ures

exe

cute

d to

el

ectr

onic

rec

ords

sha

ll be

link

ed t

o th

eir

resp

ectiv

e el

ectr

onic

re

cord

s to

ens

ure

that

the

sig

natu

res

cann

ot b

e ex

cise

d,

copi

ed,

or o

ther

wis

e tr

ansf

erre

d to

fal

sify

an

elec

tron

ic r

ecor

d by

ord

inar

y m

eans

.21

CF

R §

11.

70

Eac

h el

ectr

onic

sig

natu

re is

per

man

ently

link

ed t

o th

e as

soci

ated

dat

a se

t. U

p to

thr

ee (

3) e

lect

roni

c si

gnat

ures

can

be

appl

ied

to e

ach

file.

Bec

ause

the

sig

natu

re i

s pe

rman

ently

ass

ocia

ted

with

the

dat

a fil

e th

at i

s st

ored

in

a pr

oprie

tary

bi

nary

form

at, i

t is

not p

ossi

ble

to e

ither

rem

ove

or c

opy

any

elec

tron

ic s

igna

ture

s.

Eac

h el

ectr

onic

sig

natu

re s

hall

be u

niqu

e to

one

indi

vidu

al

and

shal

l not

be

reus

ed b

y, o

r re

assi

gned

to, a

nyon

e el

se.

21 C

FR

§ 1

1.10

0 (a

)

The

DX

Adv

/AS

1 us

es t

he s

ame

perm

issi

on le

vels

use

d at

logi

n to

app

ly e

lect

roni

c si

gnat

ures

. Thu

s,

the

elec

tron

ic s

igna

ture

is a

lway

s ba

sed

on a

uni

que

user

nam

e, ID

, and

pas

swor

d co

mbi

natio

n.

N/A

YE

S

YE

S

YE

S

Sig

nat

ure

Man

ifes

tati

on

s

Sig

nat

ure

/Rec

ord

Lin

kin

g

Ele

ctro

nic

Sig

nat

ure

s

Bef

ore

an o

rgan

izat

ion

esta

blis

hes,

ass

igns

, ce

rtifi

es,

or

othe

rwis

e sa

nctio

ns a

n in

divi

dual

’s e

lect

roni

c si

gnat

ure,

or

any

elem

ent

of s

uch

elec

tron

ic s

igna

ture

, th

e or

gani

zatio

n sh

all v

erify

the

iden

tity

of th

e in

divi

dual

. 21 C

FR

§ 1

1.10

0 (b

)

The

se c

ontr

ols

mus

t be

impl

emen

ted

by th

e in

divi

dual

com

pany

.N

/A

Feb. 15, 2010-00


15Yo

kog

awa

DA

QS

TAT

ION

Ph

arm

aceu

tica

l Mo

del

DX

Adv

ance

d A

dvan

ced

Sec

uri

ty F

un

ctio

ns

21 C

FR

§ 1

1 C

om

plia

nce

Su

mm

ary

Tabl

e

Mee

t R

equ

irem

ent?

Ele

ctro

nic

Sig

nat

ure

s

21 C

FR

§ 1

1 R

efer

ence

Co

mm

ents

NO

YE

S

N/A

N/A

YE

S

YE

S

Per

sons

usi

ng e

lect

roni

c si

gnat

ures

sha

ll, p

rior

to o

r at

the

tim

e of

suc

h us

e, c

ertif

y to

the

age

ncy

that

the

ele

ctro

nic

sign

atur

es i

n th

eir

syst

em,

used

on

or a

fter

Aug

ust

20,

1997

, ar

e in

tend

ed t

o be

the

leg

ally

bin

ding

equ

ival

ent

of

trad

ition

al h

andw

r itte

n si

gnat

ures

.21

CF

R §

11.

100

(c)

Thi

s ce

rtifi

catio

n m

ust b

e su

bmitt

ed to

the

FD

A b

y th

e in

divi

dual

com

pany

.

The

cer

tific

atio

n sh

all

be s

ubm

itted

in

pape

r fo

rm w

ith a

tr

aditi

onal

han

dwrit

ten

sign

atur

e, t

o th

e O

ffice

of

Reg

iona

l O

pera

tions

(H

FC

-100

).21

CF

R §

11.

100

(c)(

1)

Thi

s ce

rtifi

catio

n m

ust b

e su

bmitt

ed to

the

FD

A b

y th

e in

divi

dual

com

pany

.

Per

sons

usi

ng e

lect

roni

c si

gnat

ures

sha

ll, u

pon

agen

cy

requ

est,

prov

ide

addi

tiona

l cer

tific

atio

n or

tes

timon

y th

at a

sp

ecifi

c el

ectr

onic

si

gnat

ure

is

the

lega

lly

bind

ing

equi

vale

nt o

f the

sig

ner’s

han

dwrit

ten

sign

atur

e.21

CF

R §

11.

100

(c)(

2)

Thi

s ce

rtifi

catio

n m

ust b

e su

bmitt

ed to

the

FD

A b

y th

e in

divi

dual

com

pany

.

Em

ploy

at

leas

t tw

o di

stin

ct id

entif

icat

ion

com

pone

nts

such

as

an id

entif

icat

ion

code

and

pas

swor

d.W

hen

an in

divi

dual

exe

cute

s a

serie

s of

sig

ning

s du

ring

a si

ngle

, co

ntin

uous

per

iod

of c

ontr

olle

d sy

stem

acc

ess,

the

fir

st s

igni

ng s

hall

be e

xecu

ted

usin

g al

l el

ectr

onic

use

co

mpo

nent

s; s

ubse

quen

t si

gnin

gs s

hall

be e

xecu

ted

usin

g at

lea

st o

ne e

lect

roni

c si

gnat

ure

com

p on

ent

that

is

only

ex

ecut

able

by,

and

des

igne

d to

be

used

onl

y by

, th

e in

divi

dual

.W

hen

an i

ndiv

idua

l ex

ecut

es o

ne o

r m

ore

sign

ings

not

pe

rfor

med

dur

ing

a si

ngle

, co

ntin

uous

per

iod

of c

ontr

olle

d sy

stem

acc

ess,

eac

h si

gnin

g sh

all b

e ex

ecut

ed u

sing

all

of

the

elec

tron

ic s

igna

ture

com

pone

nts.

21 C

FR

§ 1

1.20

0

The

DX

Adv

/AS

1 al

low

s fo

r ei

ther

tw

o or

thr

ee id

entif

icat

ion

com

pone

nts,

eith

er a

use

r ID

/pas

swor

d or

us

er n

ame/

user

ID

/pas

swor

d co

mbi

natio

n. E

ach

com

bina

tion

mus

t be

uni

que.

Eac

h si

gnin

g re

quire

s th

at e

ach

com

pone

nt o

f the

ele

ctro

nic

sign

atur

e be

ent

ered

man

ually

by

the

user

.

Ele

ctro

nic

sign

atur

es t

hat

are

not

base

d up

on b

iom

etri

cs

shal

l: Be

used

onl

y w

ith th

eir

genu

ine

owne

rs: a

ndB

e ad

min

iste

red

and

exec

uted

to

ensu

re t

hat

atte

mpt

ed

use

of a

n in

divi

dual

’s e

lect

roni

c si

gnat

ure

by a

nyon

e ot

her

than

its

gen

uine

ow

ner

requ

ires

colla

bora

tion

of t

wo

or

mor

e in

divi

dual

s.21

CF

R §

11.

200

Pas

swor

ds a

nd u

ser

IDs

can

not

be v

iew

ed b

y ot

her

user

s. P

assw

ords

are

sto

red

in e

ncry

pted

form

at

and

can

not

be v

iew

ed b

y ad

min

istr

ator

s, o

nly

re-s

et t

o th

e or

igin

al d

efau

lt. T

he o

rigin

al d

efau

lt is

a

pre-

expi

red

pass

wor

d th

at m

ust

be c

hang

ed b

y th

e us

er i

mm

edia

tely

upo

n in

itial

log

in b

efor

e pe

rfor

min

g an

y ac

tions

on

the

DX

Adv

/AS

1.

N/A

Ele

ctro

nic

Sig

nat

ure

Co

mp

on

ents

an

d C

on

tro

ls

Ele

ctro

nic

sign

atur

es

base

d up

on

biom

etri

cs

shal

l be

de

sign

ed t

o en

sure

tha

t th

ey c

anno

t be

use

d by

any

one

othe

r th

an th

eir

genu

ine

owne

rs.

21 C

FR

§ 1

1.20

0

The

DX

Adv

/AS

1 em

ploy

s a

com

bina

tion

of p

assw

ord

and

user

iden

tific

atio

n fo

r el

ectr

onic

sig

natu

res.

It

does

not

use

bio

met

ric s

igna

ture

s.N

/A

Feb. 15, 2010-00


16

Feb. 15, 2010-00

Yoko

gaw

a D

AQ

STA

TIO

N P

har

mac

euti

cal M

od

el D

XA

dvan

ced

Adv

ance

d S

ecu

rity

Fu

nct

ion

s 21

CF

R §

11

Co

mp

lian

ce S

um

mar

y Ta

ble

Mee

t R

equ

irem

ent?

Co

ntr

ols

for

Iden

tifi

cati

on

Co

des

/Pas

swo

rds

21 C

FR

§ 1

1 R

efer

ence

Co

mm

ents

NO

YE

S

YE

S

YE

S

YE

S

N/A

Per

sons

who

use

ele

ctro

nic

sign

atur

es b

ased

upo

n us

e of

id

entif

icat

ion

code

s in

co

mbi

natio

n w

ith

pass

wor

ds

shal

l em

ploy

con

trol

s to

ens

ure

thei

r se

curit

y an

d in

tegr

ity.

Suc

h co

ntro

ls s

hall

incl

ude:

Ma

inta

inin

g

the

u

niq

ue

ne

ss

of

ea

ch

com

bin

ed

id

entif

icat

ion

code

an

d pa

ssw

ord,

su

ch

that

no

tw

o in

divi

dual

s ha

ve t

he s

ame

com

bina

tion

of i

dent

ifica

tion

code

and

pas

swor

d.E

nsur

ing

that

ide

ntifi

catio

n co

de a

nd p

assw

ord

issu

ance

s ar

e pe

riod

ical

ly c

hec k

ed,

reca

lled,

or

revi

sed

(e.g

., t

o co

ver

such

eve

nts

as p

assw

ord

agin

g).

21 C

FR

§ 1

1.30

0

The

DX

Adv

/AS

1 do

es n

ot a

llow

dup

licat

ion

of U

ser

nam

e an

d P

assw

ord

or U

ser

ID a

nd P

assw

ord

com

bina

tions

.P

assw

ords

can

be

set f

or a

utom

atic

exp

iratio

ns o

f OF

F, 1

, 3, o

r 6

mon

ths.

Suc

h co

ntro

ls [

for

iden

tific

atio

n co

des

and

pass

wor

ds]

shal

l in

clud

e:F

ollo

win

g lo

ss m

anag

emen

t pr

oced

ures

to

elec

tron

ical

ly

deau

thor

ize

lost

, st

olen

, m

issi

ng,

or o

ther

wis

e po

tent

ially

co

mpr

omis

ed t

oken

s, c

ards

, an

d ot

her

devi

ces

that

bea

r or

gen

erat

e id

entif

icat

ion

code

or

pass

wor

d in

form

atio

n,

and

to is

sue

tem

pora

ry o

r pe

rman

ent

repl

acem

ents

usi

ng

suita

ble,

rig

orou

s co

ntro

ls.

21 C

FR

§ 1

1.30

0

An

Adm

inis

trat

or c

an d

isab

le a

n ex

istin

g us

er if

an

unau

thor

ized

atte

mpt

at u

se is

det

ecte

d.W

ritte

n pr

oced

ures

wou

ld n

eed

to i

nclu

de t

he s

peci

fic c

ontr

ols

for

mai

ntai

ning

, is

suin

g, t

estin

g, a

nd

trac

king

the

assi

gned

iden

tific

atio

n co

des

and

pass

wor

ds.

Toke

ns a

nd c

ards

are

not

use

d.

Suc

h co

ntro

ls [

for

iden

tific

atio

n co

des

and

pass

wor

ds]

shal

l in

clud

e:U

se o

f tra

nsac

tion

safe

guar

ds to

pre

vent

una

utho

rized

use

of

pas

swor

ds a

nd/o

r id

entif

icat

ion

code

s, a

nd t

o de

tect

an

d re

port

in

an

im

med

iate

an

d ur

gent

m

anne

r an

y at

tem

pts

at t

he u

naut

horiz

ed u

se t

o th

e sy

stem

sec

urity

un

it, a

nd, a

s ap

prop

riate

, to

orga

niza

tiona

l man

agem

ent.

21 C

FR

§ 1

1.30

0

A u

ser’s

acc

ess

will

be

disa

bled

afte

r th

ree

(3)

or fi

ve (

5) fa

iled

logi

n at

tem

pts.

Thi

s ac

tion

is lo

gged

for

audi

t tr

ail.

If, fo

llow

ing

succ

essf

ul lo

gin,

the

DX

Adv

/AS

1 de

tect

s th

ree

(3)

or f

ive

(5)

inco

rrec

t at

tem

pts

to a

pply

an

elec

tron

ic s

igna

ture

to

a fil

e, a

ll el

ectr

onic

sig

natu

re a

cces

s to

tha

t da

ta f

ile w

ill b

e au

tom

atic

ally

dis

able

d. T

he d

ata

may

sti l

l be

pri

nted

and

sig

ned

usin

g tr

aditi

onal

han

d-w

ritte

n si

gnat

ures

.W

hen

the

DX

Adv

/AS

1 de

tect

s an

una

utho

rized

atte

mpt

at

use,

a n

otifi

catio

n sy

mbo

l ap

pear

s on

the

sc

reen

tha

t ca

n on

ly b

e cl

eare

d by

an

adm

inis

trat

or. A

utho

rized

dat

a co

llect

ion

sequ

ence

s w

ill n

ot b

e in

terr

upte

d. A

dditi

onal

em

ail

notif

icat

ion

and/

or r

elay

act

ivat

ion

for

rem

ote

notif

icat

ion

of u

ser

lock

out

are

also

ava

ilabl

e.

Suc

h co

ntro

ls [

for

iden

tific

atio

n co

des

and

pass

wor

ds]

shal

l in

clud

e:In

itial

and

per

iodi

c te

stin

g of

dev

ices

, su

ch a

s to

kens

or

card

s,

that

be

ar

or

gene

rate

id

entif

icat

ion

code

or

pa

ssw

ord

info

rmat

ion

to e

nsur

e th

at t

hey

func

tion

prop

erly

an

d ha

ve n

ot b

een

alte

red

in a

n un

auth

oriz

ed m

anne

r.21

CF

R §

11.

300

Toke

ns a

nd c

ards

are

not

use

d.

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