CerebraQ Automation implements 21 CFR Part 11 compliant SCADA and reporting systems for pharmaceutical and biotech manufacturers in India. We have delivered Part 11 implementations for multiple leading Indian pharmaceutical and vaccine manufacturers — audit trails, electronic signatures, and access control engineered into the system, with the validation documentation to support an audit. This page describes what Part 11 compliance means in a SCADA context and how we implement it.
What 21 CFR Part 11 requires of a SCADA system
Part 11 governs electronic records and electronic signatures in FDA-regulated production. For a SCADA/reporting system, the practical requirements are: secure, computer-generated audit trails that record who did what and when — operator actions, setpoint changes, alarm acknowledgements — in a form that cannot be silently edited; electronic signatures on critical operations, with the identity and meaning of each signature bound to the record; access control — unique logins, role-based permissions, password policy enforcement; and data integrity through the record lifecycle, aligned with ALCOA+ expectations (attributable, legible, contemporaneous, original, accurate). A system can be "capable of" Part 11 out of the box and still fail an audit if these are configured loosely — compliance lives in the implementation.
How we implement it
Audit trail architecture: we design the trail at the database level — SQL Server structures where records are append-only from the application's perspective, timestamps come from a controlled source, and any correction is a new record referencing the old, never an overwrite. Signature workflows: signature points are mapped to your SOPs — which operations require signature, single or double, and what each signature attests — then enforced in the application so the workflow physically cannot proceed unsigned. Access control: integration with your identity practice (local accounts or Active Directory), role definitions matched to your organizational roles, and automatic logout and re-authentication policies tuned to how the plant actually operates. Reporting: batch and production reports generated from the validated data path, so the printed record and the electronic record cannot diverge.
Validation documentation
We support the validation lifecycle rather than leaving it to the client: functional specifications written against your URS, IQ/OQ protocol support with traceability from requirement to test, and configuration documentation that lets your QA team answer an auditor's "show me where this is controlled" without calling us. Our position in an audit is behind your QA team, with the documentation already in their hands.
Beyond pharma: where Part 11 discipline pays off
The same architecture — tamper-evident records, signature workflows, controlled corrections — is what automotive traceability audits and export-market quality requirements increasingly expect. Clients outside pharma sometimes adopt the Part 11 pattern deliberately, because "we can prove exactly what happened" is valuable in any regulated or liability-sensitive production.
Frequently asked
Can you bring an existing SCADA system into Part 11 compliance?
Often, yes — it depends on whether the platform can support controlled audit trails and signatures. We assess the installed system first; sometimes remediation is configuration and procedure, sometimes a component genuinely must be replaced. The assessment tells you which before you spend.
Does Part 11 apply to Indian manufacturers?
If you produce for the US market or for customers who require FDA-aligned records, yes in practice. EU Annex 11 and WHO expectations overlap heavily, so one well-designed implementation typically serves multiple regulatory audiences.
Do you also handle the process control side in pharma?
Our scope is the SCADA, records, and reporting layer. We integrate with existing process control and BMS systems rather than replacing validated control layers — which also keeps your revalidation scope smaller.
Discuss a Part 11 project or read our pharma compliance case study.