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Technical Writing Tip of the Month - Key Elements of a Good Document
4th February 2020

Update on Three Medical Device-Related ISO Standards
19th December 2019

ISO 14971:2019 has been just been published!
11th December 2019


Computer Systems and Software Validation

Northridge can help you to comply with the latest FDA and European regulations on Computer Systems and Software Validation, and Electronic Records and Electronic Signatures (ERES).

Our qualified and experienced personnel can complete part or all of your Computer System Validation project. We specialise in the generation of;

  • URS / Intended Use Specifications
  • ERES and GxP relevance assessments
  • Validation Plans
  • Functional Specifications
  • Traceability Matrices
  • IQ, OQ and PQ protocols
  • Test Scripts
  • Validation Reports

    We specialise in the efficient validation of existing systems. We can save you time and money by the application of risk management to target the validation to the parts of the system that pose most risk to your business and to the users of your products.

    Our experts can help to take the mystery out of 21 CFR 11 compliance and develop a roadmap for full compliance on Electronic Records and Electronic Signatures of both new and existing systems.


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