The concept to achieve cGMP / FDA readiness is to produce a scalable remediation plan first, with a resource and cost estimate based on a gap analysis of the company that serves as decision base for the management.
The remediation plan then is tailored to the wishes of and approved by your management before the project is implemented. In the remediation project the internal experts are involved in the decisions and modeling of the improvements as much as possible, so that the distinctiveness of the company is taken into account and the employees consider the improvements as theirs, not as imposed. At the same time the internal experts spend a minimum of their time in the project. Instead, the external experts make sure that the best state of the art practices are implemented and carry most of the workload. A well-tried and standardized process management with templates assures the most effective and transparent project execution.
If you are interested in the concept in detail, get the white paper by means of the form on this page.
If you want to know about our customer’s experience with the concept, please read the references.