GxP Compliant Laboratory Computerized Systems (2 nd edition)
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1 GAMP Good Practice Guide GxP Compliant Laboratory Computerized Systems (2 nd edition) Tom DE RUDDER Vice-Chair GAMP COP Benelux 19 November 2013
2 GAMP 5 GAMP Good Practice Guides Figure : GAMP Documentation Structure (ISPE)
3 GAMP Good Practice Guide Laboratory Computerized Systems Why GPG 2nd Edition?
4 Why GPG 2nd Edition? PAST NOW
5 Why GPG 2nd Edition?
6 Why GPG 2nd Edition?
7 Why GPG 2nd Edition? SUMMARY The automation of laboratory testing and data management operations is increasing in sophistication and complexity. Due to the wide diversity of systems, a single prescriptive approach would be neither practical nor cost-effective. The aim is to achieve compliance, efficiency, and effectiveness within a reasonable budget and timeline for a wide variety of systems.
8 GAMP Good Practice Guide Laboratory Computerized Systems What is NEW?
9 What is NEW? 1. Describes a flexible approach consistent with GAMP 5, based on risks associated with the use of the system to support the relevant business process (scalable Life Cycle approach) 2. Applies the GAMP 5 specification, verification and implementation approach to laboratory computerized systems 3. Emphasizes the importance of leveraging supplier documentation and knowledge to avoid unnecessary duplication of efforts
10 1. GAMP 5 Scalable Life Cycle Approach A flexible approach consistent with GAMP 5 Product and process understanding (business impact) System impact on patient safety, product quality, and data integrity (risk assessment) System complexity and novelty (architecture and system components) Outcome of supplier assessment (supplier capability) Calibration of laboratory systems (instrument impact) see also : GPG A risk-based aproach to Calibration Management (ISPE, 2010)
11 Business Proces System Overview Diagram Figure : Example of Process and Data flow of GC/MS (ISPE, GPG)
12 Categorization of Laboratory Computerized Systems GAMP GPG (1st Edition) GAMP GPG (2nd Edition) GAMP GPG Subcategory A GAMP5 Categrory 3 Non-Configured Products GAMP GPG Subcategory B GAMP GPG Subcategory C GAMP GPG Subcategory D GAMP GPG Subcategory E GAMP GPG Subcategory F GAMP5 Categrory 4 Configured Products GAMP GPG Subcategory G GAMP5 Categrory 5 Customized Products Figure : Comparision of Categories in First and Second Editions of the Guide (GAMP GPG)
13 2. GAMP 5 - System Life Cycle Figure : A General Approach for Achieving Compliance and Fitness for Intended Use (ISPE, GAMP 5)
14 GAMP 5 - Specification stage Define the laboratory computerized systems functions and the intended limits of operation for the equipment as used in the laboratory. User Requirements Specifications (URS) should be produced for ALL laboratory computerized systems, but e.g. Systems with greater technical complexity will have greater available functionality, the requirements documents will reflect this complexity. For simple systems or for multiple installations of the same type of system, generic requirements documentation can be created. Functions to be used need to be tested, functions not intended to be used are not typically documented and tested.
15 GAMP 5 - Verification stage Demonstrates compliance and fitness for intended use Verification of a laboratory computerized system should provide documented evidence. Consider risk based approach Calibration, routine system suitability checks Installation verification and/or configuration Functional testing Equipment qualification versus software validation Requirements testing (performance, security, data integrity,...) Re-execution of functional testing for additional installations
16 3. GAMP 5 Leveraging supplier work Most laboratory computerized systems are configured systems (GAMP cat. 4). Leveraging supplier documentation and knowledge is acceptable, based on the outcome of your Supplier Assessment. Supplier Involvement Supplier Qualification
17 Good Practice Guide Laboratory Computerized Systems
18 Good Practice Guide Laboratory Computerized Systems Tabel of Content : Good Practice Guide (Annexes) Categories of Sofware (e.g. GAMP cat. 3, cat. 4) System Description Data Integrity Categories of Laboratory Systems ( simple, medium, complex systems) System Inferfacing Considerations (LIMS, ELN,...) Robotics systems Electronic Records and Raw Data Security Management for Laboratory Computerized Systems Supplier Documentation and Services
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