Automated Systems Validation

Automated Systems Validation

Kestrel Life Sciences are industry leaders in the field of automated systems validation.  We can assist your projects or operations at any lifecycle stage from inception to retirement; requirements to redesign; specification to testing and reporting.  Whether you need support with setting up your validation project management organisation for a small project or you want to outsource the generation of specification, test plans, configuration mangement or technical / quality reviews.  We can help you.

We recognise the era of information and technology and can be a part of any team anywhere in the world, at times to suit your requirements.  Whatever your validation requirements are, we will strive to your every need.

With expertise in the integration of various automation systems, for example control systems interfacing with manufacturing sytems via OPC and other such configurations, we not only have expertise in the technical aspects of these niche requirements, we have expert knowledge in the documenting and testing of these systems together with maintenance and support abilities.

Validation Deliverables (Sample Listing of High Frequency Requirements)

  • System Integration
  • Interface Development and Qualification
  • Reporting
  • Prospective Validation – New Systems
  • Retrospective Validation – Legacy or Non-Validated Systems
  • Re-Validation – After Changes or non-maintained validated states.
  • User Requirements Specification (URS)
  • Design Specifications – Scaled as necessary (Unit Specs, Functional Specs (FS), Detailed Design Specs (DDS/DS), etc).
  • Qualification and Test Planning (including DQ, IQ, OQ and PQ (and reports) or ISEB as required)
  • Test Case Execution and Co-ordination.
  • Electronic Records and Electronic Signatures (including specialist knowledge in Eudralex Volume 4 Annex 11 and 21 CFR Part 11)
  • Project and Validation Reporting
  • Hybrid Systems

Why Kestrel Life Sciences?

  • We provide an ‘as required’ service.
  • No employee worries or ongoing costs.
  • When you need to change, we’ll help you change.
  • We adopt the highest possible quality standards to your specification or we can advise on current trends.
  • Extensive experience in the Pharmaceutical Industry which is a qualification in itself for this type of work.
  • Highly experienced in aligning various standards and disparate methodologies to virtually any system.
  • We are unique in our approach.
  • No job too large or too small.
  • Discounts available for reoccurring clients and bulk orders.
 

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