Common sense is the talent to see things as they are and to do things the way they should be done.

Calvin Ellis Stowe

Compliance & Validation

Above all, compliance needs to be addressed with common sense and a sense of balance – as well as specialist expertise and knowledge about standards and regulations. Staying true to this mantra/value, we support you in:

  • computerised system validation according to GAMP
  • developing a validation strategy
  • creation of validation documentation
  • review of validation documentation, e.g. in the role of a project quality manager
  • GxP compliant process design and implementation
  • supplier assessments
  • internal compliance checks
  • awareness activities and training (CSV, GxP, Records Management, Good Documentation and Good Testing Practice)

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Our principles
We are honest and transparent partners to our customers, who have told us that our reliable and verifiable results have let to mutual trust.

We value and keep a constructive dialogue with your and your team, which leads to pragmatic and appropriate solutions. These, in turn, are the solutions that you and your teams will implement and embed, so that desired benefits can be realised. That your organisation is not only legally compliant but ultimately benefits from the compliance and validation solution is paramount to us.

We support you in realising these benefits by providing training, coaching or expert consultancy. We deliver bespoke solutions instead of ready-made concepts.

Gabriele Vollmar