 Save time and make FDA validation easer.
FaciliWorks simplifies the validation process with its backup/restore feature, built-in referential integrity checks, field-level input validation, standard reports and a sample validation database for end-user testing and verification. And, because FaciliWorks 8i can now incorporate calibration management, our 8i Calibration Validation Kit supports both CMMS and calibration to meet requirements for single-track FDA validation.
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 both making sure that the software itself works properly and that it works under the
purchaser's actual conditions.
FDA GMPs require that purchasers of vendor-supplied software perform 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 Validation Kit includes a step-by-step Validation Guide and a sample validation database to help you: |
