At Microrite we excel at development and implementation of phase appropriate quality systems. We support start-up as well as established companies in implementing the framework for their quality program. Through quality system procedures and functions we ensure that GMPs are followed and maintained as required by regulations. Our quality assurance team members range from former FDA inspectors to hands-on quality professionals at all levels. This ensures that no matter the project need or duration we have the right fit for your company.
- GAP assessment
- Mock PAI audits/regulatory inspection readiness
- Development, assessment and phase specific quality systems
- SOP development, batch record preparation and review
- Resolving deviations, CAPAs, OOSs, OOTs, and complaints
- Contract manufacturing organization (CMO) and vendor audits
- FDA 483 responses and remediation
- Assistance with regulatory submissions
- Computer System Validation (CSV) and Data Integrity audits