Quality Assurance

At Microrite we look at quality assurance of healthcare products as a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. Using this totality of arrangements we make sure that pharmaceutical products are of the quality required for their intended use.

  • Design and Implement Quality Systems
  • Establish Quality Plans
  • Quality Risk Management
  • Quality Mapping
  • GAP Analysis
  • Quality policy and objectives
  • Quality System Analysis and Improvements
  • Establish Risk Management Programs
  • Quality system upgrades to new standards and requirements
  • Quality Investigations
  • Corrective and preventive actions (CAPA)
  • Failures, deviations, and out of specification (OOS) investigations
  • Preparation for Pre-Approval Inspections, routine FDA Inspections and State licensure Inspections
  • Internal, External and Vendor Audits
  • Standard operating procedures (SOP) and forms
  • Regulatory documentation preparation
  • Establish quality agreements and service agreements with CMOs
  • Technology Transfer Documentation
  • Data compilation, review and reports for regulatory filings
  • GMP 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!