The document outlines the GAMP approach to data integrity, electronic records, signatures, and the operation of GxP computerized systems crucial for the pharmaceutical industry. It emphasizes the importance of data integrity, electronic data, and proper validation processes to ensure compliance and quality in pharmaceutical practices. Key responsibilities and methods for maintaining data integrity and validation of computerized systems are also discussed, along with definitions of GXP regulations.

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