COMPUTER AND COMPUTERIZED SYSTEM VALIDATION
The manner in which the Pharmaceutical and medical device industries use computers has lagged behind the world of computers and information systems used in other areas. Investigations by the U.S. Food and Drug Administration (FDA) have revealed deficiencies that have caused serious adverse effects and events resulting in illness, disease and death. These deficiencies trace their causes back to inadequate or non-existent computing practices in the pharmaceutical industry. Information acquired during research, manufacturing, clinical trials and distribution has been tainted. This is due conflict of interest, malicious intent, fraud or a basic lack of understanding the necessity for good practices in the area involving computers, their applications and use. The enactment of 21 CFR Part 11 (Code of Federal Regulations) by the FDA, forces the issue to the forefront of the industry as a whole.

The implementation of system and procedural controls are mandated to reduce human, eliminate vested interests and potential fraudulent situations. The FDA has issued written guidelines regarding computerized systems. It is expected that the Pharmaceutical companies adopt these and make them practices. Validation of all systems is now required. Compliance with 21CFR Part 11 , Electronic Records; Electronic signatures, means that all computerized systems used in environments that are required to comply with current Good Manufacturing Practices (cGMP), current Good Clinical Practices (cGCP), current Good Laboratory Practices (cGLP) and current Good Distribution Practices (cGDP), collectively known as cGxP , must also be validated and sustained in a validated state. The first requirement of 21 CFR Part 11 is “ Validation of systems to ensure accuracy, reliability, consistent intended performance and the ability to discern invalid or altered records”

To validate computer systems and ensure that they remain in validated state, procedural and technical controls have to be put in place. Documented evidence must be provided to this effect. The rule applied is, if it isn't documented, it did not happen ! Validation in accordance with part 11 requirements involves using the full System Development Life Cycle Methodology
( SDLC ). It also involves Planning, Assessment, GAP Analysis, prospective Validation, Ongoing operations, Remediation and Retrospective validation.

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