Services [ Validation - Risk Analyses ]
Consulting
GMP Office
Design&Construction Validation Production

To define what is really important and critical and to reduce the amount of effort to a minimum

Our Offer

Preparation, moderation and documentation of risk analyses according to

  • HACCP
  • HAZOP
  • FMEA
  • Failure Tree Analysis
  • And others

Our Procedure

A risk analysis is a very important instrument in reducing the amount of work in qualification and validation processes to a minimum and directing new or re-construction activities towards the given target in accordance with given requirements.

We show you feasible ways to undertake such risk analyses efficiently and effectively and, upon request, support you with advice and coordination activities.

We support you during the transfer and implementation of the results of the risk analyses into the relevant process, cleaning, and plant concepts and help you create a User Requirement Specification (URS) that, amongst other things, is the basis for the design qualification.

Your Result

Documented risk analyses. List of equipment to be qualified and a list of process steps, cleaning steps and analytical methods needing validation. List of quality-critical instruments that need calibration.



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