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Health & Pharma

Quality Work for a Pharma Diagnostics Group

Over 40 fixed-price packages since 2022 under a framework work contract

Lab technician in protective clothing at a microscope next to a bioreactor
40+fixed-price packages since 2022

Project

Health & Pharma · Test, Validation & Integration

  • Pharma diagnostics group, production and laboratories at two German sites
  • Framework work contract since 2019, individual project contract per package
  • Risk analyses, qualification documentation, SOPs, CAPA, equipment, method verification
  • Scope: over 40 quality packages since 2022
  • up to €170,000 per package
  • Acceptance every two months

Challenge

  • Testing and documentation tasks in many departments at once, with capacity lacking
  • Equipment logbooks, risk analyses and qualification documents must be auditable in the client’s system
  • Every gap puts releases, audits and delivery capability at risk

Solution

  • Every task as a package with a results list, fixed price and acceptance
  • Pharma quality experts moderate risk analyses, verify methods, review according to GDP and ALCOA+
  • Qualification and validation documentation, equipment management with logbooks
  • SOPs, deviations and CAPA, batch record reviews; GMP responsibility stays with the client

Result

  • Every package accepted against its results list
  • Departments have kept reordering since 2019, change request chains of up to nine extensions
  • Backlogs cleared without the client having to add staff

Test, Validation & Integration

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