Achieving compliance with ISPE GAMP® 5 requires software to be validated in the target environment. To support you during the validation process, we offer the PLA 3.0 Validation Package.
The PLA 3.0 framework and its add-ons come equipped with protected installation reference data. Data analysis add-ons additionally come equipped with protected operational reference data. Customers with a license for the PLA 3.0 Validation Package can decrypt the protected reference data and use it for validating PLA 3.0 in their environment.
The PLA 3.0 Validation Package provides fully automated functions for Installation Qualification (IQ) and Operational Qualification (OQ) and a semi-automated Performance Qualification (PQ) process.