21 CFR Part 11 Compliance

Compliance with the FDA 21 CFR Part 11 regulation is one of the most important requirements for a software which is meant for regulated environments. The challenge is to develop a software that is fully compliant at the core yet user-friendly on the surface. With PLA 3.0, we managed to achieve exactly that. 

PLA 3.0 uses several techniques to accomplish 21 CFR Part 11 compliance. Please take a look at this PDF should you require more details.

Electronic Signatures

Electronic Signature
Apply electronic signatures directly from the editor. Authorized with your password you can select the signature's meaning from a configured list of default meanings or override it.

PLA supports electronic signatures for entire documents and parts of the document. A document signature protects the entire document from modification. A document part signature is capable of protecting certain parts of the documents (e.g. you might want to sign and thereby protect the raw data).

Several policies allow the fine-tuning of electronic signatures according to your company standards.

Digital Signatures

Digital signatures are signatures that follow cryptographic standards. PLA 3.0 automatically applies a digital signature to every document. When you open, export or import the document, PLA validates the digital signature to ensure the document's integrity.

One of the benefits of this approach: you can transfer your documents and templates even with unsafe media (such as E-mail) and don't have to worry about it. PLA ensures the integrity of the information on its own.

Audit Trail

PLA records every change anyone makes to a document in the audit trail of the software. The audit trail can be searched and exported.

Database Policies
The images shows the various policies for fine-tuning the password rules in PLA.

Access Control

PLA requires a login to access its data. Various policies define password strength and rules. There is a fully featured role based security model allowing you to set up your databases to enforce security models suitable even for global teams. The role based approach allows you to define all required roles. The roles and permissions are organized by security context, which can easily be assigned to folders in the database.

Please read this PDF to find out more about how PLA 3.0 complies with 21 CFR Part 11 requirements.