21 CFR Part 11

Electronic Records & Signatures Aligned with 21 CFR Part 11

TurboPlatform supports electronic records and electronic signatures aligned with expectations under 21 CFR Part 11.

Part 11 establishes requirements for ensuring that electronic records and electronic signatures are trustworthy, reliable, and equivalent to paper records and handwritten signatures.

TurboPlatform Supports

Electronic records are maintained with traceability, controlled access, and documented history of changes.

Electronic Signatures

Electronic signatures are securely linked to their corresponding records and include:

Signer identity

Complete identification of the signing party

Date and time stamp

Precise recording of signature timing

Signature meaning

Clear indication of signature purpose

These controls support the creation, review, approval, and long-term retention of regulated electronic records.

TurboPlatform Supports

Electronic signatures are securely linked to their corresponding records and include:

TurboPlatform provides the structured workflows, traceability, and governance controls necessary to support GLP-aligned nonclinical study execution.

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