| Saves time and makes FDA validation easier.
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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."
Validation, as it applies to FaciliWorks facilities and maintenance management software, involves making sure that the software functions as designed. Software validation involves both making sure that the software itself works properly and that it works under the
purchaser's actual conditions.
FDA GMP's require that purchasers of vendor-supplied software are responsible for performing software validation under normal operating conditions.
To assist you in accomplishing this validation, CyberMetrics has validated FaciliWorks before its original release and continues to validate it prior to each subsequent update release. The software's
User's Manual serves as the basis by which the software is validated. A sample validation database is included in the Software Validation Kit to further assist you in validating your facility management software package and also provides help in:
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- Testing the software’s functionality.
- Preparing your standard operating procedures (SOPs) for this software.
- Training the users of the software.
- Documenting the formal validation report.
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