validation basics - gxp webinar - vaisala...9.2 qualification and validation of computerised systems...
TRANSCRIPT
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Data Integrity…Beyond Bytes and Signatures
Welcome
Paul DanielSenior Regulatory Compliance Expert
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Challenges with your audio connection? Try calling toll-free: 866-740-1260
Other technical challenges? Try logging in to webinar again.
Participate by: Answering poll questions. Ask questions using “Chat” function.
You will receive a link to the presentation in email.
Practical Webinar Stuff
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Vaisala team
Speaker:
Paul DanielSr. Regulatory Compliance Expert
Chat operator:
Janice Bennett-LivingstonMarketing Manager
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Vaisala in BriefWe 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
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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.
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Data Integrity…Beyond Bytes and Signatures
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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
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I just started1 to 3 years.4 to 10 years.10 to 20 years.More than 20 years…
POLL 1 Q: Years of GMP Experience
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Your First GMP Data Correction
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Your First GMP Data Correction
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Your First GMP Data Correction
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Your First GMP Data Correction
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Your First GMP Data Correction
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Your First GMP Data Correction
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Your First GMP Data Correction
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Moresthe customs, values, and behaviors that are accepted by a particular group, culture, etc.
– www.merriam-webster.com
Sociological Mores
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Mobile Phones
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Mobile Phones
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Summary
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1. Quality Culture teaches the unspoken GxP Rules.
Summary
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1. Quality Culture teaches the unspoken GxP Rules.
2. Learning the GxP Rules takes time.
Summary
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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.
Summary
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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.
Summary
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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.
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The Big Bang of Data Integrity
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The Big Bang of Data Integrity
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The Big Bang of Data Integrity
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The Big Bang of Data Integrity
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Data Integrity: What is it?
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Money
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Making Money
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Checks/Cheques
Bank NameRouting NumberAccount NumberCheck Number Recipient DateAmountAuthorized Signature
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Measurement
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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
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Data must beAccurateLegibleContemporaneousOriginal Attributable
Plus “+”Complete, Consistent, Enduring, Available
What is Data Integrity? “ALCOA +”
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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
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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
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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
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1. Quality Management System
2. Validation
3. Security
4. Audit Trail
5. Data Capture
6. Data Review
7. Data Storage
PIC/S Simplified
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1. Quality Management System
2. Validation
3. Security
4. Audit Trail
5. Data Capture
6. Data Review
7. Data Storage
PIC/S Simplified
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1. Quality Management System
2. Validation
3. Security
4. Audit Trail
5. Data Capture
6. Data Review
7. Data Storage
PIC/S Simplified
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1. Quality Management System
2. Validation
3. Security
4. Audit Trail
5. Data Capture
6. Data Review
7. Data Storage
PIC/S Reorganized
Data Protection
Data Capture
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1. Quality Management System
2. Validation
3. Security
4. Audit Trail
5. Data Capture
6. Data Review
7. Data Storage
PIC/S Reorganized
Data Protection
Data Capture Sensor Location
Sensor Calibration
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1. Quality Management System
2. Validation
3. Security
4. Audit Trail
5. Data Capture
6. Data Review
7. Data Storage
PIC/S Reorganized
Data Protection
Data Capture Sensor Location
Sensor Calibration
Review Of Data
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1. Quality Management System
2. Validation
3. Security
4. Audit Trail
5. Data Capture
6. Data Review
7. Data Storage
PIC/S Reorganized
Data Protection Software Functions
Security Procedures
Data Capture Sensor Location
Sensor Calibration
Review Of Data
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1. Quality Management System
2. Validation
3. Security
4. Audit Trail
5. Data Capture
6. Data Review
7. Data Storage
PIC/S Reorganized
Data Protection Software Functions
Security Procedures
Data Capture Sensor Location
Sensor Calibration
Review Of Data
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1. Quality Management System
2. Validation
3. Security
4. Audit Trail
5. Data Capture
6. Data Review
7. Data Storage
PIC/S Reorganized
Data Protection Software Functions
Security Procedures
IT Procedures
Data Capture Sensor Location
Sensor Calibration
Review Of Data
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Data CaptureSensor LocationSensor CalibrationReview of Data
Data ProtectionSoftware FunctionsSecurity Procedures IT Procedures
Data Integrityfor Enterprise Monitoring Systems
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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
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Data Capture 2: Calibration VerificationVerifications:
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Data Capture 2: Calibration VerificationVerifications: Calibration Management SOP
– SOP approved?– SOP applies to CMS sensors?
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Data Capture 2: Calibration VerificationVerifications: Calibration Management SOP
– SOP approved?– SOP applies to CMS sensors?
Calibration Certificate– Passed calibration?– Shows valid calibration dates?– Stored appropriately?
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Data Capture 2: Calibration VerificationVerifications: Calibration Management SOP
– SOP approved?– SOP applies to CMS sensors?
Calibration Certificate– Passed calibration?– Shows valid calibration dates?– Stored appropriately?
Sensor– Calibration sticker present?
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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
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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
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Data Protection 1: Software FunctionsSoftware Function Verifications
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Data Protection 1: Software FunctionsSoftware Function Verifications Access Control Features
– Uniquely identifies user Example: username
– Controls entry to programExample: password
– Controls access within programExample: user profile
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Data Protection 1: Software FunctionsSoftware Function Verifications Access Control Features
– Uniquely identifies user Example: username
– Controls entry to programExample: password
– Controls access within programExample: user profile
Audit Trail– Records all changes to data.
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Data Protection 1: Software FunctionsSoftware Function Verifications Access Control Features
– Uniquely identifies user Example: username
– Controls entry to programExample: password
– Controls access within programExample: user profile
Audit Trail– Records all changes to data.
Secure Reporting Format– Provides data in format that cannot be edited.
Example: .PDF File
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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
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Data Protection 3: IT SOPsVerifications 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?
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Data CaptureSensor LocationSensor CalibrationReview of Data
Data ProtectionSoftware FunctionsSecurity Procedures IT Procedures
Data Integrityfor Enterprise Monitoring Systems
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“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
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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
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Yes, I’m interested in… LoggersYes, I’m interested in… Validation Mapping KitYes, I’m interested in… Mapping ServicesYes, I’m interested in… Continuous Monitoring SystemYes, I’m interested in… Process InstrumentationYes, I’m interested in… Handheld devicesYes, I’m interested in… OtherNot at this time, thanks.
POLL: QuestionDo you want Vaisala to contact you?
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Paul DanielSenior Regulatory Compliance ExpertVaisala, Inc.
Email: [email protected]
Thanks for Attending!