Validation Accelerator Pack Standards - Consistency and Excellence

In the life science industry, it is important that clients define and document a consistent approach for implementation and validation of computerized systems. A vast number of Standard Operating Procedures and Work Instructions are created each year to this end.

Our Validation Accelerator Packs (VAPs) are configurable to meet our client's needs. They are ready to be updated with your user requirements, your policies and procedures. Headers and footers are easily changed to meet your own requirements. Test scripts can be added or removed depending on your intended use of the system. Most test scripts are ready to be used after a dry run to ensure that the configuration of your system has not affected the way they run.

Each of our VAP documentation sets is built carefully around a formal set of standards. This allows us to produce documentation with consistent terminology and methodology across systems.

  • Templates are developed with good formatting practices and use standardized technology.
  • Risk analysis is performed for each system to focus testing on critical functionality, reducing unnecessary testing.
  • A consistent terminology is developed for each set of VAPs.
  • A consistent dictionary of definitions and acronyms is utilized across VAPs.
  • Good documentation practices are adhered to by our technical writers.
  • Our Subject Matter Experts (often the vendors themselves) review the documentation to ensure technical accuracy.
  • All protocols are dry run as a part of the review process. This helps to ensure that the instructional steps and expected results are accurate. As well, it verifies that the proper prerequisites for execution are in place.
  • Our internal Quality Assurance team reviews each document individually to ensure consistency in formatting, styles are adhered to, and there are no spelling or grammatical errors.
  • At the completion of a VAP set, the documents are once again reviewed by our internal QA team to verify that the set is consistent prior to release. Are you automating compliance?

Our Validation Accelerators will feed automated testing systems with the best content for compliance.

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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