Implementation and Validation
For a GxP compliant system, CSV (computer system validation) is followed to ensure consistent quality proving cGxP guidelines, where the implementation is documented fully to the extent to establish and prove compliance.
As a GxP compliant system, BizNET is compliant to CSV norms (part 11 compliance – 21 CFR part 11 and Annex 11) of electronic records and electronic signatures.
Normally, CSV is dependent on the complexity of the project implementation which are guided by Master plans, Project plan, establishing the UR and FS followed by scripts (IQ, OQ, PQ) + other CSV documents. To identify here that software development and SDLC is closely linked with implementation and CSV, which, thus, establishes a thoroughly tested application. Which meets the quality standards in day-to-day operations.
Sarjen offers its expertise in validation (CSV) of the clinical trial management solution – comprehensive CSV with documentation and help in CSV execution complete validation package. This empowers users with knowledge and information to independently manage: