Compliance features in PLA 3.0

PLA 3.0 is fully compliant software, which is the most commonly used software for biostatistical analysis in highly regulated pharmaceutical and biotech industries.

21 CFR Part 11 compliance

Compliance with 21 CFR Part 11 is one of the most important requirements for software that is to be used in regulated environments. PLA 3.0 uses a variety ... Read more

Electronic Signatures

PLA supports electronic signatures for entire documents and parts of the document. A document signature protects the entire... Read more

Digital signatures

Digital signatures are signatures that follow cryptographic standards. PLA 3.0 automatically applies a digital signature to... Read more

Traceability and audit trail

PLA records every change anyone makes to a document in the audit trail of... Read more

Security

PLA 3.0 requires a login to access its data. Various policies... Read more

GAMP Compliance

PLA is a commercial off-the-shelf software solution for analyzing biological assays. Various properties allow you to... Read more

Validation

We deliver PLA 3.0 as a verified software system. The PLA Validation Package automates several tasks in the validation process on the target computer... Read more