cGMP Facility Validation

Expertise in construction management , commissioning, and validation phases can accelerate the start-up effort, reduce the validation effort and costs, produce superior documentation, and ensure that the product is produced in cGMP-compliant facilities.

  • Early programming
  • Develop User Requirement Specification (URS)
  • Manage conceptual design and BOD
  • Develop high level estimate and schedule
  • Selection of Engineering firm
  • Design Management
  • Selection of Construction firm
  • Construction Management
  • Manage construction budget and schedule
  • Develop commissioning plan
  • Develop Validation Master Plan (VMP)
  • Manage full facility validation (IQ,OQ & PQ) - facility equipment and utilities
  • Project close-out and budget reconciliation
  • cGMP Gap Analysis for existing facilities for regulatory compliance and resolution
  • Manage retrofit projects - design, construction, validation
  • Training
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!