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Validation & Qualification — IQ/OQ/PQ, CSV, Sterilization

Regulators do not accept "it works" — they require documented evidence that your 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.

IQ/OQ/PQ CSV Sterilization

What you get

• Defensible validation packages
• Right-sized CSV / CSA approach
• Sterilization & packaging assurance
• Validation master plans that scale

Standards & frameworks we work in

GHTF / FDA Process Validation 21 CFR Part 11 ISO 11135 / 11137 IEC 62304

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 the complete protocol package: validation plans, IQ/OQ/PQ protocols, test scripts and summary reports. We can also 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.