Reference

Consultancy / project management as part of computer system validation


Client

Sector : Medical technology/pharmaceutical industry

Country : Germany

Location : Bad Homburg

Staff : Approximately 800 (about 250,000 in the total group)

Performance specifications

Consultancy/project management as part of computer system validation. Tasks included, in detail:

  • Preparation of validation concepts.
  • Creation of computer validation master plans and validation documents.
  • Implementation and evaluation of risk analyses.
  • Consultancy/support in quality assurance (GxP, FDA).
The work packages were specified and to be independently processed and documented, taking into account prescribed test procedures and timelines. Faults were to be categorized and submitted to departments for validation.

provativ solution

Bereitstellung eines Beraters / Projektmanagers mit mehrjähriger Erfahrung im Bereich der Computersystemvalidierung und guten SAP-Kenntnissen.

Project duration

Over 12 months

Client's benefit

Short-term provision of resources and cost-efficient compensation of load peaks occurring in the course of the project. Relief for the internal project team. Professional and dependable mediation of resources enabling highly accurate mapping of the vacancy to requirements.

Risk data
aggregation
Professional consultancy in implementing regulatory requirements (risk data aggregation). provativ supported the data management sub-project, in particular.

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