Computerised system validation for maintenance software
Computerised system validation is the documented process of establishing that a computerised system is fit for its intended use in a regulated environment. A maintenance system that holds records required by a predicate rule — such as the 21 CFR 211.182 equipment cleaning and use log — falls within its scope, though no regulator or ISPE guidance addresses maintenance software specifically; the general framework (predicate rules, Part 11/Annex 11, GAMP 5) applies instead.
The shape of the work: a supplier assessment; a user requirement specification you author, because intended use is a statement about your process; functional and design specifications a Category 4 supplier can reasonably author for your formal acceptance; a functional risk assessment, which is yours; IQ/OQ protocols and test scripts a supplier can write and you approve; PQ or user acceptance testing, which is yours; and a validation summary report carrying your QA signature.
A supplier’s deliverables may be leveraged in place of customer-generated ones where the supplier has been assessed as competent, the deliverable has been formally accepted, and the acceptance rationale is recorded. Leveraging reduces your execution effort; it does not transfer your accountability for the conclusion. There is no such thing as “pre-validated” software — no vendor can validate a system for your intended use in your environment.
Two things a vendor should not cite: FDA’s Computer Software Assurance guidance (final, September 2025) is scoped to medical device production under 21 CFR Part 820, not pharmaceutical manufacturing under Parts 210/211; and FDA’s 2024 guidance on electronic systems, records and signatures is scoped to clinical investigations.
What MYREX offers here is set out in full on the validation page, including the parts of the package that do not exist yet — we would rather name items specifically than describe a package generically.
Sources and notes
21 CFR Part 11 (eCFR) · EudraLex Volume 4, Annex 11, Revision 1, January 2011 · FDA, Data Integrity and Compliance With Drug CGMP: Questions and Answers, December 2018 · ISPE, GAMP 5, 2nd Edition, July 2022 · FDA, Computer Software Assurance guidance, September 2025 (scoped to 21 CFR Part 820, cited here only to note its scope) · FDA, 2024 electronic records guidance (scoped to clinical investigations, cited here only to note its scope).
Want the full picture?
Read the canonical definition of a Spatial CMMS, or book a demo to see it on your own machine.