analytical equipment lifecycle management
TRANSCRIPT
Rick Jairam, M.Sc., PMP
GlaxoSmithKlineGlaxoSmithKline
What is Analytical Equipment LifecycleWhat is Analytical Equipment Lifecycle Management?
Purchasing through decommissioning. Includes equipment selection, validation, calibration, q p , , ,incident handling/troubleshooting, change control, periodic review.
Focus on GxP COTS (Commercial Off the Shelf) equipment following SILC (software implementation lifecycle)
Impacts: business cost lab efficiency complianceImpacts: business cost, lab efficiency, compliance
GAMP quote: “In a typical regulated laboratory, if the validation process is not well devised and executed, lab computerized systems may cost nearly as much to validate as they do to purchase.”to validate as they do to purchase.
About 10% of COTS instrumentation will not meet i f d li I i l duser requirements after delivery. Issues may include
software bugs, method requirements, pharmacopeia requirements, throughput requirements (automated q , g p q (systems), 21 CFR 11etc.
Poor Management of the lifecycle can lead to:Poor Management of the lifecycle can lead to:
Delay the use of new systems for severalDelay the use of new systems for several months.I fl t lid ti tInflate validation costsExposure to unnecessary compliance risk
d bReduce return on investment by increasing equipment down time.
1. Validation Plan2. Risk assessment3. User requirements4 Supplier assessment4. Supplier assessment5. IQ/OQ6. PQ/PM/Calibration7 Configuration Management7. Configuration Management8. Tracematrix & VSR9. Training, Use SOPs
Ch C l10. Change Control11. Data Backup/recovery & System administration12. Incident handling and troubleshooting13. Periodic Review14. Decommissioning
Select right equipment to meet userSelect right equipment to meet user requirementsSingle set of global requirements desirableSingle set of global requirements desirable but often difficult to achieve.Supplier Assessment looking for evidence ofSupplier Assessment – looking for evidence of a quality management system – based on equipment risk categorizationequipment risk categorization.Initial installation/validation and ongoing support from vendorsupport from vendor.
>90% of analytical equipment in a typical lab>90% of analytical equipment in a typical lab is Commercial Off The Shelf (COTS)COTS systems allow a streamlined simplifiedCOTS systems allow a streamlined, simplified validation process without dealing with design elementsdesign elements.Relies on vendor to have a good quality management system – risk deflectionmanagement system – risk deflectionNeed to have COTS definitionRisk based approach: GAMP categorizationRisk based approach: GAMP categorization
Attributes:Attributes:Exist a priori – not to be developedNon trivial install base (more than a fewNon trivial install base (more than a few copies)B h t dBuyer has no access to source codeVendor controls developmentV.Basili, B.Boehm. “COTS-Based Systems Top 10 List” IEEE Computer 34(5), May 2001, pp 91-93
Risk Based approach cGMPs for 21st centuryRisk Based approach cGMPs for 21st centuryScale validation effort based on equipment complexity and likelihood of problemcomplexity and likelihood of problem detection (risk to data integrity) - GAMP
C C C C C CCat A Cat B Cat C Cat D Cat ESimplefirmware
Simple firmware
Complex firmware
Software Software
No computer No computer No computer computer computer
No data output
Calibration storage
Method storage
Data storage Data storage andprocessingprocessing
Stirrers,sonicators
pH meters, balances
HPLC connected to validated CDS
HPLC with Chemstation control only
HPLC with Chemstation
y
May be generic for COTS equipmentMay be generic for COTS equipmentSpecifies approach (risk based)Key DeliverablesKey Deliverables ResponsibilitiesD il d j W k B kd SDetailed project Work Breakdown Structure (WBS), task duration, task sequencing,
i t b t h dl d bresource assignments best handled by a business (non GxP) project plan, e.g. MS ProjectProject.
Operation rangeOperation rangePerformance requirementsSoftware inputs outputs calculationsSoftware inputs, outputs, calculations Data integrity 21CFR11 requirementsM b ifi blMust be verifiableMust be traceable to test cases
Correct installation of hardware and softwareCorrect installation of hardware and softwareIdentification of all hardware and software -Inventory updateInventory update
Configuration:D fi iti f tDefinition of systemSecurity settings
d dCommunication, data acquisition and processing settingsData Backup - Automated means preferred.
Testing that the system will functionTesting that the system will function according to operational specifications throughout intended operational range -g p gverification of correct operation of hardware and software.
d l b d b d bVendor protocol can be used, but need to be reviewed to ensure that it meets user requirements offers time and resourcerequirements – offers time and resource savings.Responsibility for validation is on customerResponsibility for validation is on customer, not vendor.
System reliably meets user requirements inSystem reliably meets user requirements in production - Ongoing testing to maintain validated statevalidated stateDetermine appropriate system suitability, calibration tests and limitscalibration tests and limitsScheduling systemSystem for OOT investigations and businessSystem for OOT investigations and business notification
Trace requirements to testingTrace requirements to testingSummarize validation activitiesIncidents/deviations resolution of exceptionIncidents/deviations – resolution of exception reportsLi it tiLimitations on useRelease system for use
Mechanism for requesting evaluatingMechanism for requesting, evaluating, authorizing, testing and implementing changes to a validated systemchanges to a validated system.Emergency – repairProceduralized pre approvedProceduralized – pre-approvedPlanned - futureM t d fi h t t f i tMust define what aspects of equipment lifecycle will be under formal change controlCh l b il llChange control system must be agile to allow rapid changes
Incident/Problem reporting and resolution –Incident/Problem reporting and resolution –input to change control processVendor/internal resourceVendor/internal resourceGenerally more cost effective to use internal resource however need to consider:resource, however need to consider:Internal skill setR Ti i dResponse Time required
Setup user groups and accounts to meet dataSetup user groups and accounts to meet data integrity requirementsControl access to system and any externalControl access to system and any external dataComputer system maintenanceComputer system maintenanceSystem restoration in event of failureI id t ti d tIncident reporting and managementTypically independent of user to maintain d i idata integrity
Maintaining validated stateMaintaining validated stateWhat category of system will require formal reviewreview.How often? 1-3 yearsWh t t iWhat to reviewChanges to hardware, software, locationDocumentation is current – user requirementsSecurityIncidents
May be driven by usage metrics age/supportMay be driven by usage metrics, age/support, incidents.Inventory updatesInventory updatesClose out calibrationR l f ft & h dRemoval of software & hardwareRecord retention – software and data
Validation expectations and equipmentValidation expectations and equipment complexity /computerization has increased.Most medium/large pharma companies have gresponded by having dedicated resource/ group to manage the lifecycle efficientlyAlternatively have contracted aspects to vendorAlternatively have contracted aspects to vendor or third party.Cost of contracting generally about 50% higher.Cost of contracting generally about 50% higher. Still need to have internal accountability (audits) and governance. Training and retention of kill d l i k f l i lskilled personnel is key to a successful internal
group.
Parts of the lifecycle may be handled as projects,Parts of the lifecycle may be handled as projects, e.g validation – benefit from the application of good project management best practices (PMBOK®)(PMBOK ).Others are ongoing operationsNeed to have integration between projects and g joperations.Detailed knowledge of equipment that is developed during validation may be needed laterdeveloped during validation may be needed later in the lifecycle (calibration, use, troubleshooting etc.)Integration is helped by a good electronicIntegration is helped by a good electronic equipment management system.
Validation Plan Risk A
COTS Equipment Lifecycle Management
Generic and C biValidation Plan Assessment Combine
Project start Project end
IQUser Requirements
Configuration Management
Traceability matrix and
VSR
Supplier Assessment OQ/PQ
Use
Data Backup and Recovery
TrainingUse,
Calibration SOPsElectronic
Equipment Management
System
PQ / C lib ti
Change C t l
Incident Handling & Periodic
R iSoftware
Ad i i t tiCalibrationControl gtroubleshootingReview Administration
Decommissioning
Proper management of the analyticalProper management of the analytical equipment lifecycle is required to meet business and regulatory requirementsbusiness and regulatory requirements.Efficient control of the lifecycle can be achieved using good project and riskachieved using good project and risk management practices.Equipment validation adds business value andEquipment validation adds business value and should not be viewed as only a regulatory exercise that is measured by the amount ofexercise that is measured by the amount of paper generated.