Compliance
Compliance isn’t a module. It’s the foundation.
YourDocVault is engineered around the controls regulated teams are audited on — electronic signatures, a tamper-evident audit trail, controlled copies, and immutable change control. Here’s how it maps to 21 CFR Part 11 and ALCOA+ data integrity.
21 CFR Part 11
Control by control
YourDocVault provides the technical controls; your validated deployment and SOPs complete the picture.
Unique electronic signatures
Each signature is written to an append-only store recording the signer, meaning, method and GMT time — no shared or reusable signatures.
Signature re-authentication
Signing requires a fresh, contemporaneous credential / MFA re-auth against the identity service before the action commits.
Signature ↔ record linkage
Every signature links to its audit record and the exact version acted on, tying who signed to what changed.
Audit trail (§11.10(e))
A hash-chained, append-only audit log plus per-table history capture every action; nothing is editable after the fact.
Copies for inspection
Controlled copies render a cover page, watermarked pages, print footer and a full signature manifest — ready for an auditor.
Record protection
Immutable, change-controlled versions and deny-wins access rules protect records throughout their retention period.
YourDocVault provides technical controls that support 21 CFR Part 11 compliance. Compliance is achieved by the regulated organization through validation, procedures and controlled use of the system.
Data integrity
ALCOA+ by design
Attributable
Every action is tied to an authenticated user and their e-signature.
Legible
Consistent mastheads, versions and renditions keep records readable and unambiguous.
Contemporaneous
Signatures and audit entries are captured at the moment of the action, in GMT.
Original
Immutable version snapshots preserve the original record; copies are clearly stamped.
Accurate
Change-control numbers and reasons, plus tamper-evident hashing, keep the record trustworthy.
Compliance FAQ
What auditors ask
Yes. YourDocVault is designed around GxP document control: unique, re-authenticated electronic signatures; an append-only, hash-sealed audit trail; controlled copies with server-burned watermarks and signature manifests; and immutable, change-controlled versions. Final compliance depends on your validated deployment and procedures.
Signing requires a fresh re-authentication, and each signature is written to an append-only, hash-sealed store recording the signer, meaning, method and GMT time. Signatures cannot be edited or deleted, and each links to its audit record.
Only the effective version is the one users read. Releasing a new version automatically supersedes the previous one, advances the current-version pointer, and flags any outstanding controlled copies for recall.
It can. YourDocVault runs in a controlled (GxP) mode with full effective/supersede/retention/e-signature discipline, or a lighter simple (review-only) mode — selectable per document category, so strict SOPs and casual internal docs live in the same system.
Bring your next audit forward with confidence.
See the audit trail, e-signatures and controlled-copy register in a live YourDocVault walkthrough.