Quality & Validation

Validation is an integral part of the computer system life cycle, from the planning stage to the stage of retirement. This is clearly stated in Annex 11 of the European GMP and the FDA’s 21 CFR Part 11.

Based on our experience in the Life Sciences industry, we understand that the validation of READY! is a fundamental requirement for our clients.

READY! is fit for the purpose from a regulatory and business perspective, including operational benefits.

The Nanokinetik Quality Management System (QMS) is based on our extensive industry experience and up-to-date with the latest regulatory developments and industry trends.

We have successfully passed all audits performed by our clients.

GAMP5 methodology followed:

  • Stage 1: Planning and Specification
  • Stage 2: Installation on the test and production environments
  • Stage 3: Installation qualification (IQ)
  • Stage 4: System acceptance testing (OQ and PQ)
  • Stage 5: System operation

Validation documentation delivered:

  • Project implementation plan
  • Validation plan
  • Validation risk assessment
  • URS, FS, RTM
  • Guides (User, Admin)
  • Training records and materials
  • Project tracking documentation (meeting minutes, progress reports, etc.)
  • IQ (plan, records)
  • OQ (protocol, test scenarios & cases, records, report)
  • PQ (protocol, test scenarios & cases, records, report)
  • Validation report
  • Handover report

Preparation of IQ/OQ documentation and execution of the protocols is performed by the client and Nanokinetik.

PQ scripts preparation and execution is performed by the client and are supported by Nanokinetik.

Nanokinetik provides hands-on support for validated implementations through the Service Level Agreements(SLA).”