Approval clicks in regulated workflows have to be legally defensible. Aproove's are.
Aproove supports electronic signatures on workflow decisions that meet the requirements of FDA 21 CFR Part 11. Each signature is tied to a uniquely identified user, captured with secure timestamps, attributed to the specific decision and document version, and recorded with intent-of-signing in the audit trail. The result is electronic approval that an FDA inspector or compliance auditor recognizes as legally equivalent to a handwritten signature.
Choose Aproove as a 21 CFR Part 11 compliant software.
What it is
21 CFR Part 11 is the FDA regulation governing electronic records and signatures. It establishes the conditions under which electronic signatures can be considered legally equivalent to handwritten signatures in FDA-regulated industries (pharma, life sciences, medical devices, clinical research, and others).
Aproove implements e-signature support at the workflow step level. Administrators configure which decisions require a signature. When the assignee reaches that step and clicks the decision button (Approve, Reject, Sign-Off), Aproove prompts for credential confirmation, optionally with two-factor authentication. The signed decision is recorded with user identity, timestamp, decision content, file version, and intent-of-signing in the project audit trail.
How it works
Per-step configuration. E-signature requirements are configured per workflow step, not platform-wide. Routine review steps stay frictionless; signature-required steps invoke the credential prompt at the moment of decision.
Credential confirmation at signing. The assignee re-enters their credentials at the moment of signing, even if they are already logged in. This satisfies the 21 CFR Part 11 requirement that the signature be the deliberate act of the identified user, not a session artifact.
Optional 2FA. When the regulatory bar is highest, two-factor authentication can be required at the signing step as an additional identity check (see Two-Factor Authentication).
Recorded in the audit trail. Every e-signature event is captured in the project audit trail: who signed, what they signed, when, on which file version, and the decision they took. The record is exportable as part of the project's full audit history for inspections, audits, or regulatory submissions.
Benefits
- Legally defensible electronic approvals. Signatures meet 21 CFR Part 11 conditions for legal equivalence to handwritten signatures in FDA-regulated environments.
- Per-step requirement, not platform-wide. Routine steps stay light; regulated steps invoke the signature ceremony. The same workflow handles both.
- Tied to the decision, not just the session. Credential confirmation at the moment of signing satisfies the regulation's intent-of-signing requirement.
- Optional 2FA for the highest sensitivity. Two-factor authentication can be required at signing for steps where identity assurance is paramount.
- Audit-ready records. Signatures are part of the project audit trail, exportable for FDA inspection, GxP audit, or internal compliance review.
Who it's for
- Pharmaceutical and life sciences organizations working under FDA inspection scope.
- Medical device manufacturers managing design review, validation, and documentation under FDA quality system requirements.
- Clinical research organizations capturing protocol approvals, study documentation sign-offs, and regulatory submissions.
- Healthcare organizations requiring auditable electronic approval of patient-facing or regulatory documentation.
- Compliance and quality teams in any regulated industry where electronic signatures in their marketing compliance software must withstand audit.
Built for regulated environments where failures create real risk
Insurance, healthcare, and enterprise teams face unique approval challenges. Aproove handles state-by-state variations, mandated language, FDA submissions, and multi-geography brand governance without breaking a sweat.
Trusted by leaders
Used by teams that cannot afford uncertainty in their approval process.
"Implementing Aproove has dramatically reduced errors, increased motivation and satisfaction across the teams and importantly, saved the operation significant hard costs."
“The Aproove team are the best team in the world. I feel like I'm their only customer, they are always there for me.”
"Within a short period, we were able to reduce 25 workflows into a single workflow. The team saw a 15-week reduction in getting new marketing packages from idea to market. More importantly, it ensured that all the packages were compliant with regulatory requirements. All steps, comments, and approval are captured and saved for any audits."
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