Validation & Qualification — IQ/OQ/PQ, CSV, Sterilization
Regulators do not accept "it works" — they require documented evidence that processes, equipment, and software consistently produce conforming results. That evidence is validation, and thin validation packages are among the most common audit findings in regulated manufacturing.
Confiquora plans and executes validation end-to-end: process validation protocols (IQ/OQ/PQ) with statistical rationale, computer system validation right-sized under GAMP 5 and 21 CFR Part 11, sterilization and packaging validation, and master plans that scale as your operation grows.
What you get
- Defensible validation packages
- Right-sized CSV / CSA approach
- Sterilization & packaging assurance
- Validation master plans that scale
Standards & frameworks we work in
How an engagement runs
Discovery → Gap Assessment → Strategy → Implementation → Certification → Ongoing Support. Every engagement follows the same spine — scoped in the first call, priced before we start, and handed over with your team trained to run what we build.
Frequently asked questions
What is the difference between CSV and CSA?
Computer Software Assurance (CSA) is the FDA-encouraged, risk-based evolution of traditional CSV — focusing test effort where patient and product risk actually lives instead of documenting everything equally. We implement either, or a pragmatic blend.
Do you author protocols or just review them?
We author complete protocol packages — validation plans, IQ/OQ/PQ protocols, test scripts, and summary reports — and can execute alongside your team on site.
Which sterilization methods do you cover?
EtO (ISO 11135), radiation (ISO 11137), and steam — including revalidation strategy and parametric release considerations.
Talk it through with us
Free 30-minute consultation. No obligation — just a clear read on where you stand and what it takes.
Book Free Consultation