data integrity nov 2018 webinar pda 06nov18.pptx [read-only] · data review sop approved? sop...
TRANSCRIPT
![Page 1: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/1.jpg)
© Vaisala
Data IntegrityBeyond Bytes and Signatures
Paul Daniel Sr. Regulatory Compliance [email protected]
![Page 2: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/2.jpg)
© Vaisala
Vaisala Team
Speaker:
Paul DanielSr. Regulatory Compliance Expert
Chat operator:
Janice Bennett-LivingstonMarketing Manager
2
![Page 3: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/3.jpg)
© Vaisala
Vaisala in Brief We serve customers in weather and controlled environment markets
80 years of experience in providing a comprehensive range of innovative observation and measurement products and services
3
![Page 4: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/4.jpg)
© Vaisala
Vaisala - Life Science
Our Goal is to help customers• Reduce their risk of lost or
adulterated product
• Reduce their risk of failing to meet GxP regulations and/or guidelines
Our OfferingProvides measurement instrumentation, continuous monitoring systems and validation systems for regulated or highly controlled life science environments.
4
![Page 5: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/5.jpg)
© Vaisala
Data IntegrityBeyond Bytes and Signatures
Paul Daniel Sr. Regulatory Compliance [email protected]
![Page 6: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/6.jpg)
© Vaisala
History How did we get here? What is Data Integrity?
New Guidance Recent Publications
Data Integrity Practices as recommended by PIC/S for a Monitoring System Application
Goals
6
![Page 7: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/7.jpg)
© Vaisala 7
![Page 8: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/8.jpg)
© Vaisala
Your First GMP Data Correction
8
![Page 9: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/9.jpg)
© Vaisala
Your First GMP Data Correction
9
![Page 10: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/10.jpg)
© Vaisala
Your First GMP Data Correction
10
![Page 11: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/11.jpg)
© Vaisala
Your First GMP Data Correction
11
![Page 12: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/12.jpg)
© Vaisala
Your First GMP Data Correction
12
![Page 13: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/13.jpg)
© Vaisala
Your First GMP Data Correction
13
![Page 14: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/14.jpg)
© Vaisala
Your First GMP Data Correction
14
![Page 15: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/15.jpg)
© Vaisala
Moresthe customs, values, and behaviors that are accepted by a particular group, culture, etc.
www.merriam-webster.com
Sociological Mores
15
![Page 16: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/16.jpg)
© Vaisala 16
![Page 17: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/17.jpg)
© Vaisala 17
![Page 18: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/18.jpg)
© Vaisala
Mobile Phones
18
![Page 19: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/19.jpg)
© Vaisala
Mobile Phones
19
![Page 20: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/20.jpg)
© Vaisala
1. Quality Culture teaches the unspoken GxP Rules.
2. Learning the GxP Rules takes time.
3. Established Quality Culture is most effective at teaching GxP Rules.
4. Quality Culture adapts slowly to new technologies.
“Recipe for disaster”:
Summary
Immature quality culture at young companies.
New technology with computerized systems.
20
![Page 21: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/21.jpg)
© Vaisala
The Big Bang of Data Integrity
21
![Page 22: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/22.jpg)
© Vaisala
The Big Bang of Data Integrity
22
![Page 23: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/23.jpg)
© Vaisala
Data Integrity: What is it?
23
![Page 24: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/24.jpg)
© Vaisala
Money
24
![Page 25: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/25.jpg)
© Vaisala
Making Money
25
![Page 26: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/26.jpg)
© Vaisala
Checks/Cheques
Bank Name Routing Number Account Number Check Number Recipient Date Amount Authorized Signature
26
![Page 27: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/27.jpg)
© Vaisala
Measurement
05-NOV-1805-NOV-17
27
![Page 28: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/28.jpg)
© Vaisala
The Core of Data Integrity
“Ensuring that our data are sufficiently reliable that we may trust it as a basis for making GxP decisions.”
- Paul Daniel
28
![Page 29: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/29.jpg)
© Vaisala
Data must beAccurateLegibleContemporaneousOriginal Attributable
Plus “+”Complete, Consistent, Enduring, Available
What is Data Integrity? “ALCOA +”
29
![Page 30: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/30.jpg)
© Vaisala
MHRA – March 2015 “GMP Data Integrity Definitions and Guidance for Industry”
PIC/S – August 2016 (Draft) “Good Practices for Data Management and Integrity in Regulated GMP/GDP
Environments”
WHO – May 2016 “Guidance on Good Data and Record Management Practices”
FDA – April 2016 (Draft) “Data Integrity and Compliance with cGMP – Guidance for Industry”
Latest Publications
30
![Page 31: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/31.jpg)
© Vaisala
Section 2.4 Data Integrity “…is fundamental in a pharmaceutical quality system which
ensures that medicines are of the required quality. Poor data integrity practices and vulnerabilities undermine the quality of records and evidence, and may ultimately undermine the quality of medicinal products.”
Section 3.4 “This guide is not intended to impose additional regulatory burden upon
regulated entities, rather it is intended to provide guidance on the interpretation of existing PIC/S GMP/GDP requirements relating to current industry practice.”
PIC/S Data Integrity
31
![Page 32: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/32.jpg)
© Vaisala
9. Specific data integrity considerations for computerised systems 9.1 Structure of QMS and control of computerised systems 9.2 Qualification and validation of computerised systems 9.3 System security for computerised systems 9.4 Audit trails for computerised systems 9.5 Data capture/entry for computerised systems 9.6 Review of data within computerised systems 9.7 Storage, archival and disposal of electronic data
PIC/S Table of Contents
32
![Page 33: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/33.jpg)
© Vaisala
1. Quality Management System2. Validation3. Security4. Audit Trail5. Data Capture6. Data Review7. Data Storage
PIC/S Simplified
33
![Page 34: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/34.jpg)
© Vaisala
PIC/S QMS Recommendations
Manage per existing GxP Requirements
Manage Critical Systems with MATURE QMS
Follow Part 11 / Annex 11 / PI 011
Reminder that a system is more than just computers…– It is also people and processes.
34
![Page 35: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/35.jpg)
© Vaisala
PIC/S Validation Recommendations
Assemble Specifications on Data Integrity Controls – Approved Users and Privileges–Data Review– Procedures - Managing Users and Protecting System
“Normal” Validation–Master Validation Plan–GAMP-Style Qualification– Periodic Revalidation
Manage Data Through System Transitions
35
![Page 36: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/36.jpg)
© Vaisala
1. Quality Management System2. Validation3. Security4. Audit Trail5. Data Capture6. Data Review7. Data Storage
PIC/S Simplified
36
![Page 37: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/37.jpg)
© Vaisala
1. Quality Management System2. Validation3. Security4. Audit Trail5. Data Capture6. Data Review7. Data Storage
PIC/S Reorganized
Data Protection Software Functions
Security Procedures
IT Procedures
Data Capture Sensor Location
Sensor Calibration
Review Of Data
37
![Page 38: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/38.jpg)
© Vaisala
Data CaptureSensor LocationSensor CalibrationReview of Data
Data ProtectionSoftware FunctionsSecurity Procedures IT Procedures
Data Integrityfor Enterprise Monitoring Systems
38
![Page 39: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/39.jpg)
© Vaisala
Verifications:
Is the correct sensor installed? –Model– Serial Number
Is the sensor in the correct location?
Is the sensor fixed in place?
Data Capture 1: Location Verification
39
![Page 40: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/40.jpg)
© Vaisala
Data Capture 2: Calibration Verification
Verifications: Calibration Management SOP– SOP approved?– SOP applies to CMS sensors?
Calibration Certificate– Passed calibration?– Shows valid calibration dates?– Stored appropriately?
Sensor–Calibration sticker present?
40
![Page 41: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/41.jpg)
© Vaisala
Verifications
Data Review SOP approved?
SOP includes the following:–Responsibilities for Data Review.–Clear definitions of acceptable data.– Actions to take for unacceptable data.
Data Capture 3: Data Review Verification
41
![Page 42: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/42.jpg)
© Vaisala
Monitoring systems can capture data directly from sensors.
To apply “Data Capture” to other types of computerized systems, you may need additional verification activities.
Data Capture: Additional Thoughts
42
![Page 43: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/43.jpg)
© Vaisala
Data Protection 1: Software Functions
Software Function Verifications
Access Control Features–Uniquely identifies user
Example: username–Controls entry to program
Example: password–Controls access within program
Example: user profile
Audit Trail–Records all changes to data.
Secure Reporting Format– Provides data in format that cannot be edited.
Example: .PDF File
43
![Page 44: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/44.jpg)
© Vaisala
Verifications Site Physical Security SOP Password Management SOP Periodic User Review SOP Audit Trail Review SOP
All SOPs must be: Approved? Include the monitoring system?
Data Protection 2: Security SOPs
44
![Page 45: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/45.jpg)
© Vaisala
Data Protection 3: IT SOPs
Verifications Change Management SOP Disaster Recovery SOP Data Back-Up SOP–Daily (Local)–Weekly (Protected Local)–Monthly (Protected Off-Site)
All SOPs must be: Approved? Include the monitoring system?
45
![Page 46: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/46.jpg)
© Vaisala
Data CaptureSensor LocationSensor CalibrationReview of Data
Data ProtectionSoftware FunctionsSecurity Procedures IT Procedures
Data Integrityfor Enterprise Monitoring Systems
46
![Page 47: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/47.jpg)
© Vaisala
“Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and to provide controls to prevent omission of data.”
“The computerized system lacked access controls and audit trail capabilities.”
“All employees had administrator rights and shared one user name.”
“Electronic data could have been manipulated or deleted without traceability.”
Recent FDA Warning Letter – May 2016
47
![Page 48: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/48.jpg)
© Vaisala
“Failure to maintain complete data derived from all laboratory tests conducted to ensure your API complies with established specifications and standards.”
“…the software was configured to permit continuous use of the “preview run” function and routine overwriting of previous runs.
“Our review of the audit trail demonstrated that multiple distinct runs were performed.”
“Only the final “preview run” in each project folder was retained.”
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm611369.htm
FDA Warning Letter – China, December 2017
48
![Page 49: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/49.jpg)
© Vaisala
“Failure to maintain complete data derived from all laboratory tests conducted to ensure your API complies with established specifications and standards.”
“Your firm does not ensure that complete data from testing of your API are included in the official batch record and reviewed by your quality unit.”
“…our investigator found unreported analyses including out-of-specification (OOS) results for [a released lot] ... You failed to include this data to be reviewed by your quality unit prior to the release of the lot.”
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm614609.htm
FDA Warning Letter – Japan, November 2017
49
![Page 50: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/50.jpg)
© Vaisala
“Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)).”
“You recorded results for tests you admitted that you did not conduct.”
Your firm also failed to document critical information on microbiological worksheets.”
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm620002.htm
FDA Warning Letter – USA, September 2017
50
![Page 51: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/51.jpg)
© Vaisala
Review
History How did we get here?What is Data Integrity?
New Guidance Recent Publications
Data Integrity Practices as recommended by PIC/S for a Monitoring System Application
51
![Page 52: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/52.jpg)
© Vaisala
Other information on Data Integrity
Data Integrity White PaperData Integrity InfographicBlogs:Q&A from our recent Data Integrity WebinarData Integrity Redux: Two New Guidance DocumentsCustomer Cases:Read how Teva Pharmaceuticals maintained data integrity during a Hurricane
52
![Page 53: Data Integrity Nov 2018 Webinar PDA 06NOV18.pptx [Read-Only] · Data Review SOP approved? SOP includes the following: –Responsibilities for Data Review. –Clear definitions of](https://reader030.vdocuments.us/reader030/viewer/2022040116/5eb70bca05838848e81490e8/html5/thumbnails/53.jpg)
© Vaisala
Paul DanielSenior Regulatory Compliance ExpertVaisala, Inc.
Email: [email protected]
Send Questions & Comments to:
53