cGMP Utilities and Equipment Validation

cGMPs necessitate that, items which have impact on the quality of product should be qualified/validated.
Qualification/Validation should provide documented verification that the parameters defined as critical for operation and maintenance are adequately controlled. Microrite ensures that the qualification/validation is practical and achievable.

  • Early programming
  • Validation Master planning
  • Develop User Requirement Specification URS
  • Develop Utility Matrix
  • Develop equipment specification
  • Develop equipment layout
  • Manage equipment procurement
  • Manage/develop/witness FAT and SAT
  • Manage equipment installation
  • Start-up and commissioning
  • Validation Project Management
  • Training
  • Testing
  • AA

Is this working? 

3 Cs for Microrite

Three Cs for Microrite

C1: Creativity - We believe that creativity, not additional capital, generates the most effective solutions. This is the reason why we use a risk based approach and quality by design approach in all our work.

C2:  Communication - We have no secrets and give no surprises. We always will tell you what is happening and teach you everything we know. We communicate!

C3: Cost conscious - We help you succeed by treating your project as our business. Establishing phase specific systems to avoid overkill and overspending is our specialty.

Do it Once...Do it Right!