“Confirmation by examination and provision of objective evidence that computer systems specifications conform to user needs and intended uses, and that all requirements can be consistently fulfilled”

FDA Guidance for Industry 21 CFR Part 11, Glossary Draft Version August 2001

• Computer System Validation (CSV) is the documented process of assuring that a computer system does exactly what it is designed to do in a consistent and reproducible manner.
• The validation process begins with the system proposal/requirements definition and continues until system retirement and retention of the e-records based on regulatory rules.

What needs Validation?

New and existing

Computerized systems and devices which collect, process, capture, store, archive, retrieve, transmit   or manipulate data that may be included in a submission to a regulatory authority are involved in manufacturing, controlling, testing, packaging, holding or distributing products or substances for human or veterinary use

A computer system is defined as:

• Any programmable device including its software, hardware, peripherals, procedures, users, interconnections and inputs for the electronic processing and output of information used for reporting or control.

Approach to Validation and Lifecycle

Validation of computer systems is not a onetime activity. Starts with user requirements and continues validation activities until finished lifetime of the system and last record.

Historical Perspective and Guidance

• FDA guide to Inspection, 1983
• Compliance Policy Guide, 1987
• Notable problems in the late 80’s
• NASA
• Connecticut Blood Bank
• EMA GMP GUIDE, Annex 11 1989
• GAMP Guide, 5^th Edition , February 2008
• PDA (Parenteral Drug Association) Technical Report 18, 1995
• Software development guidelines
  • ISO 9000-3
  • IEEE
  • …

Current EU Regulations

• GMP Directive, 2003
• (EudraLex Vol.4) New in January 2011

For Computer and Control systems , two sections are important

• Chapter 4 :  Documentation
• Annex 11 :   Computerized System

• FDAD, Code of Federal Regulations (21 CFR Part 11)

Official Guidance

• PIC/S : INSPECTION OF COMPUTERISED SYSTEM
• FDA : COMPUTERISED SYSTEM IN CLINICAL TRIALS
• FDA : GENERAL PRINCIPLES OF SOFTWARE VALIDATION
• ASTM E2500-07:GUIDE TO THE VERIFICATION OF PHARMACEUTICAL AND BIOTECHNOLOGY MANUFACTURING EQUIPMENT
• ENO 27001 : INFORMATION SECURITY MANAGEMENT

GAMP5 Approach
Good Automated Manufacturing Practice

“GAMP5 Guidance aims to achieve computerized system that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner”