Service 11
Quality Management Systems (QMS) for CROs, Labs & Institutions
A Quality Management System is the documented framework that makes your work consistent, traceable and defensible—how procedures are written and controlled, how people are trained, how deviations are investigated and corrected, and how leadership knows the system is working. For CROs, laboratories, schools and research programs, sponsors, accreditors and inspectors expect that framework to exist and to be followed. Building and running it in-house takes time most scientific teams do not have. Priestly Consulting acts as your third-party quality partner: we build the system with you, keep it current, and prepare you for the audits and inspections that test it—so your scientists can stay focused on the science.
Scope of support
What this engagement covers
- QMS gap assessments against your target framework
- QMS design and build-out from the ground up, scaled to your size
- Quality manual, quality policy and quality objectives
- SOP writing, review and lifecycle management
- Document control and records management (including 21 CFR Part 11 considerations for electronic records)
- Training programs, competency assessment and training records
- Deviation, nonconformance and CAPA management with root cause analysis
- Internal audits and audit program scheduling
- Vendor and supplier qualification
- Risk management and change control
- Management review and quality metrics
- Sponsor audit, accreditation and regulatory inspection preparation, plus response to findings
- Ongoing outsourced quality support ("quality as a service")
What you can expect
- An audit-ready quality system that matches how your organization actually works
- The burden of quality administration lifted from your scientists and leadership
- Senior quality expertise without a full-time quality hire
- A stronger position when sponsors, accreditors or inspectors review your work
FAQ
Quality Management Systems (QMS) for CROs, Labs & Institutions: common questions
Related services
Often paired with
Let's discuss your quality needs.
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