Controlled documents, built for the regulated life sciences floor.
Controlled documents, electronic signatures, audit trails and role-based approvals for SOPs, quality manuals and training records. Built to support your FDA 21 CFR Part 11 workflows for electronic records and signatures.
Reason: Approved · 12 Aug 2026, 14:22 UTC · locked to record
Audit trail
AuthoredA. Rao
ReviewedS. Mehta
ApprovedQA Head
Signature meanings
AuthorSigned
ReviewerSigned
QA ApproverSigned
When an SOP change has to reach every operator, and prove it did.
A deviation is raised on the injectables line. The CAPA closes with a revised SOP. That revision has to be reviewed, approved with an electronic signature, made effective, and read and understood by every operator, QC analyst and supervisor it applies to, before they touch the process again. The previous version must retire cleanly, stay retrievable, and never be mistaken for the current one.
PolicyCentral.ai gives QA, Regulatory and Manufacturing one controlled system for that: a single document lifecycle, electronic signatures with meaning, an audit trail that cannot be edited, and training acknowledgement tied to the exact revision, built to support your 21 CFR Part 11 workflows.
At a mid-size pharma manufacturer
Two plants. Four hundred SOPs. One version of the truth.
A formulations and injectables manufacturer with two sites, a QC laboratory, an R&D group, and a few hundred controlled SOPs, quality manuals and work instructions. Every month brings revisions: a CAPA-driven SOP update, a change control that touches three documents, a new regulatory guidance that has to cascade to the shop floor, and a training obligation attached to each one.
Shared drives and printed binders cannot prove who read the current version, cannot stop someone working to a superseded revision, and turn an inspection into a scramble. The quality team needs controlled documents, electronic signatures, a clean audit trail, and training records an auditor can read in one filter.
That is what this looks like on PolicyCentral.ai. The operator opens the effective SOP on the shop floor tablet, the system logs the read and the training acknowledgement, and the QA lead watches coverage climb on the dashboard, revision by revision.
The controls a regulated quality system expects.
A controlled lifecycle, Draft to Obsolete.
Every controlled document moves through defined states: Draft, In Review, Approved, Effective, and Obsolete. Only an Effective version is visible to the floor. When a revision is approved, the prior version retires automatically and stays retrievable in the archive. No document goes live without passing through review and approval, and nothing effective can be quietly edited underneath your people.
Each signature records who signed, when, and what the signature means, Authored, Reviewed, Approved, or Acknowledged. The signature is bound permanently to that record and that version. It cannot be copied to another document or transferred to another user. Re-authentication at the point of signing and a captured signing reason make each approval defensible when an inspector asks how it was applied.
Every material action, created, edited, reviewed, approved, made effective, superseded, read, acknowledged, is written to a time-stamped trail that no user, including an administrator, can alter or delete. Where a value changed, the trail holds the previous and the new value. When the auditor asks who approved SOP-QA-014 v4.0 and who was trained on it, the answer is one filter and one export, not a week in shared drives and inboxes.
Operators view and author. Reviewers review and comment. QA managers approve or reject. Administrators configure the system. The person who drafts a document cannot be the one who approves it, so segregation of duties is enforced by the platform, not by trust. Access is granted by role, site and function, and it updates automatically as people join, move or leave.
Can: View effective SOPs, acknowledge, complete training
ReviewerQA
Can: Review, comment, e-sign as Reviewed
QA ManagerApprover
Can: Approve or reject, make effective, retire versions
Every revision on record, none of them lost.
A controlled document cannot be changed in place. Any edit creates a new, numbered revision that carries its change reason, its change-control reference, its approvers, and its effective date. Superseded versions stay in the archive, readable and retrievable for the full retention period, so the history of what was effective, and when, is always answerable.
When a revision goes effective, the read-and-understand and training obligation attaches to it automatically for the roles and sites it applies to. A short quiz backs the read where you need evidence of comprehension, not just a click. The result is a training record linked to the precise document version, so "trained on the current SOP" is a fact you can prove, per person, per revision.
There is no FDA certification for Part 11 software, and any vendor claiming to be "Part 11 certified" is misstating it. What a platform can do is provide the capabilities that let your validated system meet Part 11 for electronic records and electronic signatures. Here is how PolicyCentral.ai maps to those requirements.
Electronic signatures
Signed, attributed, bound to the record
Signer identity, date, time and signing meaning, permanently linked to the version and not transferable.
Audit trail
Time-stamped, tamper-evident
Every material action recorded, with previous and new values, and no ability to edit or delete the trail.
Access control
Role-based, least privilege
Permissions by role, site and function, with maker and checker duties kept separate.
Authentication
Unique identity, MFA, password policy
Every user uniquely identified, with multi-factor authentication and enforced password rules.
Record integrity
Controlled, versioned, protected
Effective records cannot be altered in place; changes create a new controlled revision.
Retention
Readable and retrievable
Records retained for your defined period, retrievable throughout, for inspection and review.
Time-stamping
Date, time and user on every action
Consistent, system-applied timestamps on approvals, acknowledgements and changes.
Validation support
Documentation for your CSV
Materials to support installation, operational and performance qualification within your own quality system.
Compliance note. PolicyCentral.ai provides capabilities that help regulated organizations meet FDA 21 CFR Part 11 requirements for electronic records and electronic signatures. Final compliance depends on the customer's own configuration, standard operating procedures, procedural controls, and system validation. PolicyCentral.ai does not claim to be "21 CFR Part 11 certified" or "HIPAA compliant"; no such certification exists for software, and compliance is achieved by the customer within their validated environment.
Real moments. Real quality teams.
Five situations a pharma quality and regulatory team faces every month.
A CAPA closes with an SOP revision
The revised SOP is authored, reviewed and approved with electronic signatures, made effective, and the prior version retires. Training attaches automatically, and coverage climbs before the line restarts.
Lifecycle → E-signature → Training on revision
The inspector asks "who was trained on v4.0?"
One filter on the document and revision returns every signature, every acknowledgement, every quiz score, per person, per site, exported in minutes rather than reconstructed over a week.
Audit trail → Filter → Export
Someone tries to work to a superseded SOP
Only the effective version is visible on the floor. The superseded revision sits in the archive, clearly marked, retrievable for the record but never mistakable for the current one.
Controlled lifecycle → Effective-only visibility
A new guidance has to reach two sites
A regulatory update cascades to Unit I and Unit II, in the language each site reads, with acknowledgement captured per operator and a clean record for the file. No all-company email, no guessing who saw it.
Controlled distribution → Translation → Acknowledgement
An approver signs, and it has to mean something
The QA Head re-authenticates at the point of signing, the reason is captured as Approved, and the signature is bound to that exact record. When the meaning of a signature is questioned in an audit, the answer is on the record, not in someone's memory.
Signature meaning → Re-authentication → Bound to record
From "which version is current?" to "controlled, signed, and trained on."
1
Document control
From shared drives and printed binders to one controlled lifecycle, effective-only on the floor.
2
Approvals
From a scanned signature on a PDF to an electronic signature bound to the record, with meaning.
3
Inspection readiness
From a week reconstructing who read what to one filter, one export, per revision.
Live Customers
Ready to bring your controlled documents on to one platform?
Bring one SOP, its revision history, and your approval flow. In 30 minutes we'll show you the controlled lifecycle, the electronic signature, the audit trail, and the training record an inspector would ask for.
