A CASE STUDY: The modification of a legacy process control system

Values That Stand The Test of Time

A CASE STUDY: The modification of a legacy process

control system

[The case for data integrity without “Part 11" compliance]Presented by John T. English

Validation & Regulatory Compliance

TECHNIP BIOPHARM, INC.


A Case Study: Legacy and Data IntegrityA Case Study: Legacy and Data Integrity

Preliminary ObservationsPreliminary Observations

Part 11 compliance has meta-expectationsPart 11 compliance has meta-expectations

Not every system is a mainframe or networkedNot every system is a mainframe or networked

Criticality is in the eye of the beholder! Criticality is in the eye of the beholder!

Not all data is created equally.Not all data is created equally.




Response to a production needResponse to a production need

Adapt an existing custom application platformAdapt an existing custom application platform

Use ‘proven’ technologies to avoid delayUse ‘proven’ technologies to avoid delay

Have all calculations and record-keeping be as Have all calculations and record-keeping be as automated and paperless as possibleautomated and paperless as possible

Let the operators do their jobs andLet the operators do their jobs and ‘just walk away’ ‘just walk away’




What were the results?What were the results?




SYSTEM DESIGNSYSTEM DESIGN

INFRASTRUCTURE:INFRASTRUCTURE:Intel Processor/ Windows 9XIntel Processor/ Windows 9XPLCPLC

APPLICATION ENVIRONMENT:APPLICATION ENVIRONMENT:Custom/bespoke applicationsCustom/bespoke applications

Higher level language program for instructionsHigher level language program for instructionsGraphic tool for HMIGraphic tool for HMIStandard tool for Ladder LogicStandard tool for Ladder Logic

ORGANIZATIONALORGANIZATIONALProceduresProceduresDocumentationDocumentationTrainingTraining




ISSUES: 1. SDLCISSUES: 1. SDLCInformal Methodology, not an elaborate Model.Informal Methodology, not an elaborate Model.

2. SECURITY2. SECURITYThe ‘ ON/OFF’ switch security approachThe ‘ ON/OFF’ switch security approachLocked doors do not = locked systemLocked doors do not = locked system

3. PROCEDURES3. PROCEDURESCovered system operationCovered system operationNOT system dataNOT system data

4. DATA ARCHIVING4. DATA ARCHIVINGSee Number 3 – ‘NOT’See Number 3 – ‘NOT’

5. AUDIT TRAILS5. AUDIT TRAILSNone apparent.None apparent.




Response: Lack of Data IntegrityResponse: Lack of Data IntegritySolution: Solution:

A. Write the SOP to documentA. Write the SOP to documentthe existing data backup “practice”the existing data backup “practice”

‘Take credit for …’ copying file,‘Take credit for …’ copying file, maintaining drive, storing transmittal media maintaining drive, storing transmittal media and archive of date to network directoryand archive of date to network directoryunder security under security

B. Overcome Objections:B. Overcome Objections:It’s not fully compliantIt’s not fully compliantThe FDA won’t like itThe FDA won’t like itThey only want to see optical mediaThey only want to see optical media




Response: Lack of Data IntegrityResponse: Lack of Data IntegritySolution: Solution:

C. Demonstrate the ability to retrieve dataC. Demonstrate the ability to retrieve data

All files were availableAll files were available

Rapid retrievalRapid retrieval

IT security combined with departmental proceduresIT security combined with departmental procedures

Time and date stampingTime and date stamping




Source for the following :Source for the following :

US FDA Office of Regulatory AffairsUS FDA Office of Regulatory Affairs

Investigation Operations Manual (2003)Investigation Operations Manual (2003)

Chapter 5 Establishment InspectionChapter 5 Establishment Inspection

Subchapter 520 - Evidence Development Subchapter 520 - Evidence Development Sections 527-529Sections 527-529




527.44 Data Integrity of Records Provided by Firm 527.44 Data Integrity of Records Provided by Firm Many manufacturers are using computers to store records concerning Many manufacturers are using computers to store records concerning

complaints, failure data, returned goods, servicing, testing results and complaints, failure data, returned goods, servicing, testing results and others. Record traceability and data integrity are always concerns when others. Record traceability and data integrity are always concerns when you copy or use computerized data. you copy or use computerized data.

It is difficult to determine what records are to be designated as originals It is difficult to determine what records are to be designated as originals or copies of original records. It is important, when obtaining hardcopy or or copies of original records. It is important, when obtaining hardcopy or copy of computerized data, for you to capture some method of dating. copy of computerized data, for you to capture some method of dating. The date of an electronic file can be captured by recording The date of an electronic file can be captured by recording the date and time from a file listing in DOS or with File Manager in the date and time from a file listing in DOS or with File Manager in Windows.Windows.

This may not always be possible, but some attempt should be made to This may not always be possible, but some attempt should be made to date and time stamp electronic data.date and time stamp electronic data.




FINAL NOTESFINAL NOTES

Compliance is not supposed to an unattainable goalCompliance is not supposed to an unattainable goal

Errors are expected – and expected to be controlledErrors are expected – and expected to be controlled

‘‘A good procedure today is better than A good procedure today is better than a plan to make a perfect system a plan to make a perfect system some time in the future.’some time in the future.’

In a perfect world, data integrity In a perfect world, data integrity will NOT be an issue. will NOT be an issue. For the rest of us, there is still the FDA.For the rest of us, there is still the FDA.




A Reflection:A Reflection:““Machines are built by menMachines are built by men

and will always be at risk of failing. and will always be at risk of failing. All we can do is make themAll we can do is make themas safe as possible as safe as possible and ensure that those who operate and ensure that those who operate the machines act responsibly."the machines act responsibly."

A CASE STUDY: The modification of a legacy process control system

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