A GAMP Approach to Data Integrity, Electronic Records & Signatures & Operation of GxP Computerized Systems

1. DRUG
INTERNATIONAL
LTD (UNIT-2)
TRN-23
Topic:
A GAMPApproach to Data Integrity, Electronic Records & Signatures &
Operation of GxP Computerized Systems.
Trainer:
Sazal Sutradhar
HR In-charge
Drug International Ltd. (Unit-2)

2. Contents:
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 GAMP
 Data Integrity
 Electronic Data
 Electronic signatures
 Operation of GxP Computerized Systems.

3. GAMP-Good Automated Manufacturing Practice
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 A technical sub-committee of the International Society for Pharmaceutical Engineering
(ISPE).
 GAMP was initiated in 1991 by David Selby (founding chair) and Clive Tayler in the
United Kingdom.
 A system for producing quality equipment using the concept of prospective validation
following a life cycle model.
 Specifically designed to aid suppliers and users in the pharmaceutical industry.
 Guide for Validation of Automated Systems in Pharmaceutical Manufacture
 Latest Version: GAMP-5
 GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems provides
a framework for the risk-based approach to computer system validation where a
system is evaluated and assigned to a predefined category based on its intended use
and complexity.

4. Data Integrity
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 Protection of data from unauthorized and unaccountable changes.
 Overall Safety, accuracy, completeness, and consistency of data regard to
regulatory compliance.
ALCOA
 Attributable: Information is captured in the record
 Legible, traceable and permanent: Data are readable, understandable, and
allow a clear picture of the sequencing of steps or events
 Contemporaneous: Recorded at the time they are generated or observed
 Original: First or source capture of data or information
 Accurate: Correct, truthful, complete, valid and reliable

5. Data Integrity
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Responsibility for ensuring data integrity, including:
• Executives and managers
• Process and data owners and data stewards
• Technical system owners
• System developers, maintainers, and users
• Quality Assurance and Quality Control
• Clinical, manufacturing, and laboratory personnel
• Validation and compliance specialists
• Suppliers of systems and services
• IT and engineering professionals

6. Data life cycle
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 Raw data: The original record /source data
 Metadata: Contextual information about data: unit, milligram, gram, kilogram, and so
on.

7. Ways to Ensure Data Integrity
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 Perform Risk-Based Validation.
 Select Appropriate System and Service Providers.
 Audit your Audit Trails.
 Change Control.
 Qualify IT & Validate Systems.
 Be Accurate.
 Archive Regularly.

8. Electronic Data
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 Everything that is stored electronically: emails, adverse event reports, complaints,
batch records, quality control records
 Examples :
 Desktop, laptop and tablet computers, Smart phones, Servers, hard drives and
monitors.
 Network-connected printers and copiers.
Importance of Electronic data
 Detection of data integrity failures: deletion, amendment, duplication, reusing and
fabrication.
 Making batch release decisions
 Approval of stability results,
 Analytical method validation etc.

9. Electronic signatures
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 A digital form (bio-metric or non-biometric) representing the signatory
 An electronic signature should be:
 attributable to an individual;
 free from alteration and manipulation; and
 date- and time-stamped, where appropriate.
 validated;

10. How should the company design and control paper documentation system
to prevent unauthorized recreation of data?
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Expectations to consider Template (Blank) Form|:
 Have a unique reference number (including version number)
 Corresponding SOP number
 Should be stored in a manner which ensures appropriate version control
 If signed electronically, should use a secure e-signature
Distribution of template records:
 Using logbook with numbered pages, distribution date, a sequential issuing number, the
number of the copies distributed, the department name.
 Photocopying using a secure stamp or appropriate system.
What control should be taken to preserve original electronic data?
 Make provisions such that original data cannot be deleted
 Retention of audit trails reflecting changes made to original data.

11. GxP: “Good x Practice”
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 GxP is a set of regulations and quality guidelines formulated to ensure the safety of
life sciences products (manufacturing, control, storage, and distribution.)
 Calibration: A process that demonstrates a
particular instrument or device produces results
within specified limits.
 Validation: Documented evidence which provides a
high degree of assurance to a desired result with
predetermined compliance.
 QMS: A quality management system & regulatory
requirement that FDA and other global regulatory
bodies consider critical.

12. LIMS (Laboratory Information Management System)
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13. Operation of GxP Computerized Systems.
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 Computer System Validation (CSV)
 Software Validation– Computer systems validation services : LIMS
 Spreadsheet Validation – Spreadsheet security and compliance
How to validate a computer system?
 Develop Clear and Precise Functional and User Requirements.
 Perform risk-based CSV.
 Create a Good Validation Plan.
 Create a Good Team.
 Avoid Ambiguous Test Scripts.
 Create Good Documentation.
 Audit third-party Providers.

14. URS: (User Requirement Specification)
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 Computer system requirements:
 Hardware
 Operating System
 Network system
 Data Base Management System
 System software
 Strategy
 Compliance
 Software life cycle.

15. Computer System Validation Steps
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 DQ:
performs the requirements outlined in the Functional Requirements.
 IQ:
verifies the proper installation and configuration of a System.
 OQ:
to verify the proper functioning of a system.
 PQ:
to verify that a system performs as expected under simulated real-world conditions.
DQ
IQ
OQ
PQ

16. IQ: Verification Components:
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System No:
Meet Acceptance Criteria (Yes/No)
Processor RAM
Graphics
Card
Hard Disc
Power
Supply
Monitor
Network
Host
Operating
System
S1
S2
S3
SYSTEM NO
MODEL & SPECIFICATION
Processor RAM Graphics Card Hard Disc Power Supply Monitor Network Host
Operating
System
S1
S2
S3

17. OQ Verification Components:
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 Operating condition:
 On/off condition of all the system
 Data restore and backup system of all software Documents.
 Hardware matches with its assign function
 Security and safety verification
 Functional testing of software to assess the computer program
 Verification of Operation- Function of input and output of result in software

18. PQ Verification Components
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 Audit Trail
 Change Request
 Approval of change
 Back-up
 3rd Party Access
 Risk Assessment
 Validation Plan
 Validation Report
 User Instructions
 Training Records
 Performance Qualifications
 Database Lock
 Change Control

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End of The Session