Quality Management System

To meet the regulations, we can deliver a complete set of 5 primary and 5 supporting CSV procedures (see picture below) and more than 50 templates for every possible validation document related to the processes described by the procedures.

The procedures and templates can be used immediately after authorization. The company specific details are gathered and maintained in a separate compact document. A standard implementation plan controls that the new approach is introduced in a natural way.

Although the regulations state that IT can be treated as in internal supplier with their own validation approach, we pay special attention to acceptance by the internal customers!

CSV Outsourcing

We can take care of all or a subset of your CSV activities. This can vary from one to all of the processes mentioned above and from one to all of your computer systems or projects.

Resources can work remote or on site. To minimize the costs you can also use your own resources. As the approach is easy to use, your resources can be persons with little CSV background, changing jobs or returning from illness or maternity leave.

Ad-hoc Services

Services such as: System Inventory, System Validation or Remediation, CSV Training, Period Review, Supplier Audit, Infrastructure Qualification or Inspections Readiness can be provided on request.