Compliance and validation: DQ, IQ, OQ, PQ
XiltriX supplies the full validation package: URS and functional specification for design qualification, IQ documents recording exactly what was installed, an OQ protocol proving the system meets its specification, and PQ procedures you repeat in normal use. Together they form the validation report you hand to an auditor.
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URS, functional specification and DQ
XiltriX provides the User Requirement Specification and the functional specification that start the validation process. Both are compared against your actual requirements, and the outcome is captured in a review document: the first part of the validation report. Any later change is recorded on the supplied change request forms. This stage is commonly called design qualification.
Installation Qualification
After installation, the IQ documents record every detail: part numbers, serial numbers, delivery dates, firmware and software versions, and how the installation was carried out. The finished IQ is a blueprint of the system as built, component by component, and forms the second part of the validation report.
Operational Qualification
The OQ protocol confirms the installation meets the functional specification. It describes each test and produces printed evidence that the system performs as specified. The completed OQ is captured in a review document that also joins the validation report.
Performance Qualification
PQ is the recurring exercise that proves the system still performs correctly under normal daily conditions. XiltriX provides documents and procedures that largely automate it, and the results are archived inside the system itself.
Validation and calibration answer different questions. Calibration asks whether a sensor reads correctly; validation asks whether the whole system does what it was specified to do. You need both, on different intervals.
Frameworks the documentation supports
- FDA 21 CFR Part 11 electronic records and signatures
- GxP and GAMP 5
- ISO 15189 and ISO 17025 laboratory accreditation regimes
- CAP laboratory accreditation
- Joint Commission International
- HACCP for food and related processes
XiltriX International itself is certified to ISO 9001 and ISO 27001. The certificates are available on the company page.
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