Validation

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.

You are looking for details on compliance with 21 CFR Part 11?
Please consult our 21 CFR Part 11 Compliance brochure.

The Installation Qualification process (IQ process) of the PLA 3.0 Validation Package checks the completeness and correctness of the PLA 3.0 installation.

  • Fully automated
  • Certificate upon successful execution
  • Detailed report

The Operational Qualification process (OQ process) of the PLA 3.0 Validation Package verifies the correctness of mathematical calculations performed by PLA 3.0 on the target system, using data sets verified by Stegmann Systems.

  • Fully automated
  • Certificate upon successful execution
  • Detailed report

The Performance Qualification process (PQ process) of the PLA 3.0 Validation Package verifies the correctness of mathematical calculations performed by PLA 3.0 on the target systems, using data sets verified by the customer.

  • Semiautomated
  • Certificate upon successful execution
  • Detailed report