Evidence to support your software validation.
Introducing software to a regulated production environment means qualification, documentation and change control. The admission gate was designed around the same questions, so its records can support your qualification and change-control procedures.
Where an agent fits the quality system.
- Deviation
- Observed state disagreeing with the batch record, captured when it happens rather than at reconciliation
- NCR
- A nonconformance raised with the frame that triggered it already attached
- CAPA
- Corrective action supported by retained evidence rather than by recollection at the review
- GAMP 5
- Risk-based categorisation of the software being introduced, and the validation effort that follows from it
- IQ / OQ / PQ
- Installation, operational and performance qualification. Device-fit evidence can support IQ; it does not constitute a complete qualification protocol
- CSV
- Computer system validation, which is the activity this is trying to make cheaper rather than replace
21 CFR Part 11
Part 11 applies to certain electronic records and electronic signatures used to meet FDA requirements. Validation, access controls and record integrity must be assessed for the intended use and applicable predicate rules. Read the FDA scope guidance.
Every admission decision produces a signed manifest, a timestamped verdict, the identity and version of the model that produced it, and the device it was admitted against. That is the attributable, contemporaneous, original shape the rule asks for — retained rather than reconstructed.
Drug manufacturing operates under 21 CFR Parts 210 and 211. Device manufacturing quality systems are governed by the Quality Management System Regulation (QMSR), effective 2 February 2026, in 21 CFR Part 820. It incorporates ISO 13485:2016 by reference. FDA QMSR overview.
What a deviation costs before it is found late.
A deviation requires investigation and an assessment of product impact. Finding it after release can widen that investigation and may require field action. Timely observations help the quality team establish scope and decide the response.
Assess the impact using your own downtime, rework, investigation and operating costs. Agree a baseline and success criteria for the evaluation.
The argument here is not that fewer deviations occur. It is that the evidence needed to close one is captured when it happens, with its model, device and source context available for review.
How admission evidence supports validation.
The Oddy test was not designed against a regulatory framework. It arrived at the same three questions because they are the questions anyone introducing software to a controlled environment has to answer. The mapping is not a claim of compliance — it is an observation that the work overlaps.
- Identity
- Publisher, version and SHA-256 digest match the signed manifest — configuration item identification
- Fit
- Memory, runtime and accelerator sit inside the measured envelope of the named device — supporting evidence for Installation Qualification
- Reach
- Nothing beyond what you granted on that device — access control and least privilege under 21 CFR Part 11
This automates documentation your team currently produces by hand. It does not replace validation, and Indagate holds no certification against any regulation named on this page.
Configure the platform around your equipment.
Start with a relevant industry pack, then tailor its equipment points, monitoring rules and alerts to your specifications. Combine it with compatible custom models and map checks to the standards and procedures your team works to.
Bring your validation protocol.
Send the qualification protocol you use for new software today. The free audit comes back with which sections the admission record already satisfies and which it does not.