Engineering Services
Our engineers work with some of the industry leading vendors on numerous projects from developing the User Requirement Specifications (URS) and project management to cost analysis and Functional Design Specifications.
Track and Trace / Serialization System Implementation
cGMP Consulting has experience specifying, commissioning, and qualifying serialization systems. We have validated the serialization process and converted 70 products from non-serialized to serialized versions.
Equipment / Facilities / Utilities Qualification
cGMP Consulting uses a Risk Based Approach (RBA) to Qualification that aligns with the current FDA thinking on qualification.
Process and Cleaning Validation
Our engineers have the ability to generate cleaning matrixes, assess clean-ability, recommend cleaning agents, and develop the associated documentation to confirm that your process is in compliance.