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Digital Signatures Built to Comply with FDA 21 CFR Part 11
PharmaDoX gives life-sciences teams cryptographically secure, tamper-evident signatures with permanent legal evidence – engineered from the ground up to satisfy 21 CFR Part 11 for clinical, quality, and regulatory records.
Every control the regulation expects – built in, not bolted on
PharmaDoX maps directly to the technical requirements of Part 11, so electronic signatures are as trustworthy and enforceable as handwritten ones in FDA-regulated processes.
Signer Authentication
Signers are positively authenticated before they can access or sign a record – satisfying Part 11's identity-verification and access-control requirements.
Integrity & Security
Each signature is cryptographically bound to the document with PKI, so any unauthorized change after signing is immediately detectable.
Comprehensive Audit Trails
Time-stamped, computer-generated audit trails capture every relevant action – sending, viewing, signing – and cannot be altered or obscured.
Non-Repudiation
Once applied, signatures and their meaning, signer, and timestamp cannot be repudiated – meeting FDA expectations for enforceable electronic records.
Long-Term Validation
Signatures carry their own permanent legal evidence and remain independently verifiable for decades – without depending on SIGNiX's continued existence.
Accurate Record Copies
Generate complete, human-readable copies of records and their audit trails for FDA inspection – in both display and portable formats.
A compliant signing flow, start to evidence
Prepare the record
Upload the protocol, batch record, or SOP and place signature, initial, and date fields with required signing reasons.
SOPs · protocols · batch recordsAuthenticate the signer
Signers verify identity via credentials and a second factor before any signature can be applied to the record.
Multi-factor identity checkSign with meaning
Each signature captures the signer, timestamp, and the regulated reason for signing, then is cryptographically bound to the document.
Reason + PKI bindingSeal & preserve evidence
A tamper-evident seal and full audit trail are embedded, producing a permanently verifiable record ready for inspection.
Tamper-evident sealEvidence an inspector can trust
Every action on a record is captured in an immutable, time-stamped audit trail – independently verifiable long after signing, with no reliance on a vendor portal.
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Computer-generated & time-stampedEach event is recorded automatically with a trusted timestamp – never editable by users.
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Cryptographically sealedThe trail is bound to the signed document, so tampering with either is immediately detectable.
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Independently verifiableValidity can be confirmed offline, for decades, supporting FDA audit and legal discovery.
Purpose-built for clinical, quality & regulatory work
PharmaDoX fits the records pharma, biotech, and CRO teams sign every day – replacing paper while keeping every workflow compliant.
Clinical
Keep trials moving without compromising compliance.
- Protocols & amendments
- Informed consent
- Investigator agreements
- Case report forms
Quality
Approve and release with a defensible record.
- SOPs & work instructions
- Batch & device records
- CAPA & deviations
- Change controls
Regulatory
Submission-ready signatures and evidence.
- Submission documents
- Regulatory correspondence
- Validation & audit packages
- Quality agreements
We help you walk into the audit prepared
PharmaDoX ships with the documentation and validation support your team needs to pass FDA audits and validation exercises – so compliance is something you can demonstrate, not just claim.
See PharmaDoX against your Part 11 checklist
Bring your requirements. We'll show you exactly how PharmaDoX authenticates signers, seals records, and produces the evidence your auditors expect.