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By Master Control
Computer Systems Validation Overview
FDA-regulated companies are very familiar with a variety of validation processes ranging from full process and facilities validation to that of qualifying individual utilities, equipment, instruments and everything in between. When it comes to 21 CFR Part 11 and computer systems validation, however, regulated companies are purchasing configurable electronic quality management systems from software manufacturers that may have little or no experience with validation. This is especially important since the vendor is responsible for managing the ongoing development and maintenance of the system.
The use of vendor-supplied “off-the-shelf” configurable software offers many challenges to validation, including supplier audits. A knowledgeable and “validation-ready” supplier can make the process much easier and faster. To this extent, regulated companies must continually educate themselves about validation of computer systems for electronic documentation management as applied in 21 CFR Part 11. FDA expectations for Part 11-compliance and validation of computer systems were seen initially in the FDA 483s and Warning Letters issued during inspections.
Now we are operating within the new FDA enforcement discretion under the September 2003 Guidance for Industry; Part 11, Electronic Records; Electronic Signatures – Scope and Application.
This white paper will provide an overview of computer systems validation and what FDA is requiring companies to do to become or stay compliant.
 Click Here to read the complete Whitepaper...
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