Software Validation Kit

Saves time and makes FDA validation easier.

The FDA defines validation as “establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specification and quality attributes.”

Software validation, involves making sure that software functions as designed. Software validation involves both assuring that the software itself works properly and that it works under the purchaser’s actual conditions.

FDA Validation GMPs require that purchasers of vendor-supplied software are responsible for performing the software validation under its normal operating conditions and maintaining international standards.

To assist you in accomplishing this validation, CyberMetrics validates software before its original release and continues to validate it prior to each subsequent update release to ensure compliance with ISO 9000 standards along side the FDA regulations. The Validation Guide's User’s Manual serves as the basis by which the software is validated for international standards. A sample validation database is included in the Validation Kit to further assist you in validating your software and also provides help in: