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Agenda
Validation Effort
Client vs Supplier
Validation Responsibility
How to Maintain the Validated Status US CFR Part 11 vs. EU cGMP Annex 11
Agenda
Validation Effort
Client vs Supplier
Validation Responsibility
How to Maintain the Validated Status US CFR Part 11 vs. EU cGMP Annex 11
What is computer system validation? The most quoted definitions of validation process of a Computerized System come from the FDA:
The collection and evaluation of data, from the process design state through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.
Guidance for Industry, Process Validation: General Principles and Practices, January 2011.
Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.
FDA Guideline on general principles of process validation, May, 1987
Computer System Validation is the documented evidence that a Computerized System, while performing its intended functions consistently and reliably, ensures the integrity of quality product data
Validation shows that the system does what you say it does and is under control
Validation does not prove that a SW application works in any condition (to be ensured by SW Vendor through his own Quality System)
NOT just to satisfy regulations: To gain knowledge of the system To achieve in-depth knowledge necessary to Control the system To allow safe, effective changes to the system To Recognize system failures To investigate thoroughly system failures
More than just testing: DEFINE the system DESIGN the system DEMONSTRATE performance of intended function & does not perform unintended function DOCUMENT the system
Problem Statement Do I have confidence that my results are complete and accurate?
Comment
Users need documentation that explains how to use the system and how to confirm that results are accurate. Testing is one of the biggest user concerns.
Problem Statement
Did the construction and maintenance of the system the company uses meet regulations?
Comment
CSV scope
The Computerized System is composed by: The controlling system The controlled process in an operating environment
(PICS/S - Good Practices For Computerised Systems In Regulated GxP Environments).
Computerized system
SOFTWARE
INFRASTRUCTURE (NETWORK)
COMPUTERIZED SYSTEM
OPERATING ENVIRONMENT
(PICS/S - Good Practices For Computerised Systems In Regulated GxP Environments).
Definitions (1/2)
Process: A set of specified, ordered actions required to achieve a defined result. System: A group of related objects designed to perform or control a set of specified actions Function: A set of specified, ordered actions that are part of a process.
Definitions (2/2)
PROCESS START COMPUTER PRESS FUNCTION A ON MENU PRESS FUNCTION C ON MENU TURN OFF COMPUTER
Computerized Systems determined to have an impact on pharmaceutical quality and/or patient safety must be maintained in a validated status within the whole lifecycle (i.e. from implementation to retirement)
Prospective validation
Prospective Validation is establishing documented evidence that a system does what it is intended to do based upon a pre-planned protocol, implemented prior to distribution of either a new product or a product made under a revised manufacturing process, where the revisions may affect the products characteristics.
Retrospective validation
Retrospective Validation is establishing documented evidence that a system does what it is intended to do whereby historical data that has been reviewed and analyzed can be used to support the validation
Prospective Validation is not an option. The Validation process must be part of the implementation project.
NEW SYSTEM IMPLEMENTATION DEFINITION NEW SYSTEM DESIGN VALIDATION TEST GO-LIVE
Agenda
Computer System Validation Computer System Life Cycle Validation Effort Client vs Supplier Validation Responsibility How to Maintain the Validated Status US CFR Part 11 vs. EU cGMP Annex 11
Requirements
System
Selection
Documentation
Validation is a PROCESS
not an event
Validation Testing
Supplier
Testing
Build
To build a case that the software is validated requires time and effort. The final conclusion that the software is validated should be based on evidence collected from planned efforts conducted throughout the software life cycle
General Principles of Software Validation; Final Guidance for Industry and FDA Staff January 11, 2002; Par. 2.4
related to
Performance Qualification
Functional Specification
related to
Operational Qualification
Design Specification
Installation Qualification
GAMP 5 Guideline
GAMP 5 Approach
to
UK
industry from
for 31
comments
As Second Draft, but incorporating EC GMP Annex 11 Revision and new content, incorporating further comments from Europe and the USA Revision and new content. Separation into User and Supplier Guides. Addition of Volume Two
Version 3.0
March 1998
GAMP IV
December 2001
Major revision and new content in line with regulatory and technological developments. Broadened scope to include regulated healthcare industries. Greater coverage
GAMP V
Major revision providing a flexible and robust quality risk-based approach to compliant GxP regulated computerized systems, based on a scaleable life cycle from concept to retirement. New information on topics of special interest also provided