Process Validation

Process Validation

As industry leaders in the field of Process Validation and have supported clients with Process Validation efforts in bio/pharma and recycling companies to date.  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.

All tasks and activities comprise a process of some description and we understand that your business and manufacturing processes are formed in this way.  Whether you have a manual process that must be controlled and verifiable or a hybrid of a computerised and manual system, we can work with you to ensure that not only is your process validated and documented correctly, but also to ensure that the validated state is maintained, auditable and most importantly that your process is consistently yielding consistent results – time and time again.

Validation Deliverables (Sample Listing of High Frequency Requirements)

  • 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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