GxP vision system an auditor can follow
Machine vision for regulated production with data integrity built in: a SHA-256 hash-chained audit trail, electronic signatures following 21 CFR Part 11, immutable batch records and a validation kit for GAMP 5-based qualification.
Data integrity by design, not by SOP.
A vision system that is fast but not trustworthy creates a documentation problem instead of solving one. Regulators expect computerized systems in GxP production to create records that are attributable, contemporaneous, original, accurate and protected for their whole life: the ALCOA+ principles behind 21 CFR Part 11, EU GMP Annex 11 and data integrity guidance.
- Attributable
- Every action is recorded against a named user, from local accounts or Active Directory, with password policy and account lockout.
- Contemporaneous & original
- Results are written at the moment of capture, together with the annotated evidence image the verdict was based on.
- Protected
- The audit trail is append-only and SHA-256 hash-chained. A built-in verification re-walks the chain and exposes any change.
- Complete
- Settings changes, model loads, logins, captures and signatures all land in the same trail, including which model version, by SHA-256, was active.
Electronic signatures with meaning.
Closing a batch requires re-entering username and password and choosing the meaning of the signature. The signature is bound to the record, shown in the PDF report and logged in the audit trail. Once closed, a batch is immutable.
Role permissions are defined in an editable matrix, while safety-critical settings stay admin-only and are enforced on the server, not just hidden in the interface.
A validation kit in the box.
Steadeye is classified as a GAMP 5 category 4 configured product. It is delivered with a computerized system validation (CSV) starter kit your QA team can execute as-is or adapt to its SOPs.
- Installation Qualification (IQ)
- Confirms correct installation on qualified hardware, including the SHA-256 of the build and of the model.
- Operational Qualification (OQ)
- Challenge tests for every function, with the deepest coverage on audit trail, batch immutability, e-signatures, access control and count correctness.
- Performance Qualification (PQ)
- Demonstrates that the station performs in your real production process, with your products.
- Traceability matrix (RTM)
- Maps every requirement to design, automated tests and OQ test cases.
The built-in simulation mode runs the complete workflow with synthetic trays and a known count, ideal for OQ dry-runs before the cameras are mounted.
One qualified process. No cloud to audit.
The whole station, including detection, web interface, database and PLC drivers, runs as one signed application on a single Windows PC, installed with one setup and licensed offline. There is no cloud service or external dependency to assess, and your production data never leaves the site.
Questions quality teams ask.
What makes a vision system GxP compliant?
No software is compliant on its own; compliance comes from a validated system used under controlled procedures. What the vision system must provide are the technical controls: unique user accounts, a secure audit trail, electronic signatures, protection of records against change, and documentation that makes validation possible. Steadeye provides these controls and ships the validation templates.
Does Steadeye support 21 CFR Part 11?
Steadeye provides the technical controls Part 11 expects: audit trail, electronic signatures with meaning, account security and record protection. Procedural controls and system validation remain with the regulated company; the included IQ, OQ and PQ templates support that work.
Which GAMP 5 category is Steadeye?
Category 4, configured product. The validation approach in the included kit is risk-based and concentrates on data integrity, access control and count correctness.
Can the audit trail be exported and verified?
Yes. The audit trail can be exported and its hash chain verified; the verification result is one of the attachments recommended for the OQ.
Does it work with Active Directory?
Yes. You can switch between local accounts and AD/LDAP with group-to-role mapping.
Keep reading.
Pharmaceutical vision system
Counting and damage inspection with GxP-grade evidence, from trigger to signed batch record.
Read more →Tablet & capsule counting
Up to six cameras compare every tray with its expected quantity: OK, SHORT, OVER or NO_TRAY.
Read more →The complete station
Check logic, batch record, audit trail, training, PLC integration and installation on one page.
Read more →See it count your product.
Book a live demo and walk through the complete workflow, from capture to signed batch record, on the running station.