Our service ...

You are working in a GxP-regulated environment (e.g. pharmaceuticals, biologics, medical devices, food and beverages) and need qualified automation equipment and validated computer systems? Either retrospectively or prospectively?

As part of an internationally operating healthcare group we can offer you qualification and validation services which are state of the art and focus on the operator's requirements.

We know from experience - experience we are only too happy to share with you - that with qualification and validation procedures a lot of money can be saved if the requirements are appropriate and the whole concept is right. We can therefore perform the following tasks for you:

• Preparation or review of the required instruction system
  • taking your QM system into account (gap analysis and action plan)
  • on the basis of the life cycle model
• Project management for qualification and validation so that the GxP requirements are integrated into the project process from the start.

Our services related to the execution of qualifications and validations extend from the project idea right up to assistance with product approval. Our range of services includes the following:

• Preparing the validation master plan
• Examining the existing system documentation (gap analysis) in the case of retrospective validation
• Drawing up plans for system qualification under the V model (in accordance with GAMP)

We also offer the following modules:

• GxP review of requirements and performance specifications
• Preparation/review of risk analysis (FMEA, HACCP)
• GxP review of tender documents
• Execution of supplier audit
• Drawing up/review of qualification test schedules for IQ, OQ and PQ taking FAT and SAT into acount
• Design qualification (DQ) and drawing up of the requirement traceability matrix
• Execution and GxP-compatible documentation of IQ, OQ and PQ
• Drawing up of qualification and validation findings
• Assessment and documentation of conformity with 21 CFR Part 11
• Assistance in drawing up system documents for product submission in accordance with CTD

Once the system has been qualified or validated, this status must also be maintained in day-to-day operation. To ensure this we assist you by:

• Establishing procedures for configuration and change management
• Drawing up SOPs for system operation
• Training employees in the GxP-compatible supervision of qualified and validated systems
• Carrying out system reviews and audits

If this is too much for an initial order, the services described can be obtained from us as a complete package or individually in line with your requirements, either on a stand-alone basis or as an integral part of our range of process control engineering and operational management services.