Validation: controlled processes and evidence that stands up to audit.

We plan and perform validation of your device's manufacturing, sterilisation, cleaning and software (CSV) processes, with IQ/OQ/PQ protocols and traceable evidence for ANVISA and MDSAP audits.

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Validation: controlled processes and evidence that stands up to audit.
What we deliver

We bring your critical processes to a validated, documented state.

  1. Validation master plan (VMP) and risk-based prioritisation.

  2. Installation, operational and performance qualification (IQ/OQ/PQ).

  3. Validation of sterilisation processes (EtO, radiation and moist heat).

  4. Validation of cleaning and special processes.

  5. Validation of production software and quality system software (CSV).

Deliverables

What you receive

A validation master plan (VMP).
IQ/OQ/PQ protocols and reports.
Sterilisation and cleaning validation reports.
CSV documentation for computerised systems.
References

Reference standards

  • ISO 11135 (EtO), ISO 11137 (radiation) and ISO 17665 (moist heat/steam).
  • ISO 13485:2016 - process validation within the QMS.
  • Software validation requirements (e.g. FDA CSV/CSA principles).
FAQ

Frequently asked questions

Let's talk

Are your critical processes validated and ready for audit?

We structure IQ/OQ/PQ and sterilisation validation.

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