Quality Management Systems for Labs
OUR CLIENTS
Quest Diognostics
Pharmasol
CoNCERT
Aspenti health
Tarveda
Dr. Reddy's
RTI International
Genzyme
Blend Therapeutics
Abbott
Harvard University
Massachusetts Institute of Technology
Test America
Sunkist
Boston university
Phenomenex
USGS
Pioneer
Schwabe
Pfizer
Translate bio
Amgen
USPS
What Is Quality Management System Services?
Quality Management Services (QMS) provide the framework for ensuring that every process within a laboratory meets established standards for accuracy, reliability, and compliance. It defines how laboratories develop, document, monitor, and continuously improve their operations to maintain consistency and regulatory readiness.
A well-implemented QMS supports all aspects of laboratory function, including equipment qualification and calibration, data integrity, audits, and corrective action programs. It establishes a framework of accountability that enables labs to operate efficiently while maintaining confidence in every result.
At
Overbrook Support Services, we help laboratories establish and strengthen QMS processes that enhance compliance, support audit preparedness, and promote continuous improvement throughout the
lab’s lifecycle.
What is Overbrook QMS Implementation?
Overbrook’s QMS approach combines regulatory expertise with a strong understanding of laboratory operations. We guide labs through each phase of implementation, from initial assessment to ongoing improvement.
Our Quality Management Services include:
- Developing or revising SOPs and documentation structures
- Assessing existing systems for regulatory alignment
- Supporting ISO, GMP, and GLP compliance readiness
- Conducting internal audits and mock inspections
- Establishing CAPA and nonconformance management processes
- Training laboratory staff on QMS principles and best practices
- Supporting IQ/OQ/PQ validation and qualification activities
By integrating quality principles into daily operations, Overbrook ensures that your QMS is both practical and compliant.
What Are the Core Elements of a Laboratory QMS?
A successful laboratory QMS integrates key components that provide oversight, documentation, and continuous improvement across every aspect of the lab. These include:
- Document Control: Managing and maintaining all SOPs, records, and controlled documents for traceability.
- Training and Competency Management: Ensuring personnel are properly trained and qualified for their assigned responsibilities.
- Equipment Qualification and Calibration: For GxP laboratories, verifying instrument performance through IQ/OQ/PQ processes and ongoing maintenance.
- Nonconformance and CAPA Management: Tracking issues, identifying root causes, and implementing corrective and preventive actions.
- Audit and Compliance: Conducting internal reviews and maintaining readiness for external regulatory inspections.
- Management Review and Continuous Improvement: Using performance metrics to evaluate system effectiveness and drive improvement.
Together, these components establish a process that promotes consistency, transparency, and sustained operational excellence.
Partner with Overbrook
A reliable Quality Management System is essential to maintaining compliance, consistency, and confidence in laboratory operations. Overbrook provides the structure, technical expertise, and ongoing support your lab needs to perform efficiently at every stage of its lifecycle.
Audit and Compliance Support for Laboratories
A Quality Management System should not only define how a laboratory operates but also ensure continuous readiness for audits, inspections, and regulatory reviews. Overbrook’s audit and compliance support helps laboratories proactively identify risk, strengthen documentation, and approach audits with confidence.
Our audit and compliance services include:
- Internal Audits and Readiness Reviews
- We conduct structured internal audits and readiness assessments to evaluate alignment with regulatory and quality standards. These reviews help uncover gaps before external inspections and reduce the risk of findings.
- Mock Audits and Inspection Preparation
- Overbrook supports laboratories through mock audits that simulate real inspection scenarios. This process helps teams understand expectations, identify weaknesses, and prepare documentation and workflows ahead of formal audits.
- Documentation and Record Review
- We assess SOPs, policies, training records, equipment logs, and quality documentation to ensure consistency, traceability, and compliance with regulatory requirements.
- Compliance Gap Analysis and Remediation Planning
- When issues are identified, our team develops clear remediation plans with prioritized actions, timelines, and accountability to strengthen compliance and improve audit outcomes.
- Ongoing Compliance Support
- As laboratories grow, change, or relocate, we help maintain compliance through continuous QMS oversight, documentation updates, and audit preparedness aligned with evolving regulatory expectations.
By integrating audit and compliance support into your Quality Management System, Overbrook helps laboratories reduce risk, improve operational consistency, and maintain long-term regulatory confidence.
How Does QMS Integrate with Overbrook’s Lifecycle Services?
A Quality Management System functions across every part of the laboratory lifecycle. Each of Overbrook’s services contributes to a stronger foundation of quality.
| Equipment Planning | Establishes documentation and validation standards from the start. |
|---|---|
| Lab Relocation Services | Maintains compliance, traceability, and validation during transitions. |
| Contract Maintenance | Provides records for calibration, preventive maintenance, and audits. |
| Asset Management | Ensures lifecycle traceability, performance data, and reliability. |
| Audit and Compliance Support | Offers readiness reviews, documentation audits, and remediation plans. |
By connecting quality with every service, Overbrook helps laboratories maintain reliability, compliance, and performance from design through daily operation.
Why Partner with Overbrook for Quality Management Services?
Overbrook Support Services brings decades of experience in laboratory operations, compliance, and engineering. Our team helps clients implement systems that meet regulatory standards while improving daily efficiency.
Each QMS solution is customized to fit the laboratory’s environment, scientific goals, and compliance requirements. The result is a practical and sustainable system that strengthens both operational performance and quality assurance.
