Quality
SGS PSI is part of the world’s leading testing, inspection and certification company, known as the global benchmark for quality and integrity
Quality forms a core foundation of SGS PSI and permeates everything we do. This foundation ensures we follow sound scientific practices as well as good business practices when dealing with clients, vendors, and regulatory bodies. Our entire company, from our laboratory staff to our support staff, must know and adhere to established quality practices. This is reflected through the quality frameworks, systems and compliances that we have developed internally to gauge our testing, performance and service delivery. Our dedication to achieving and maintaining the highest standards when it comes to quality assurance, audits and accreditations gives our customers the confidence that we will provide the technical excellence they expect.
Quality Assurance
Our unparalleled quality assurance protocols and processes deliver reliable data. Our dedicated Quality Assurance Team and Quality Management System mandate that we pay superior attention to detail and work with strict confidentiality to produce defensible documentation and results. We utilize an electronic document management system (EDMS) that is 21 CFR Part 11 compliant to ensure security and traceability of our documents and records. We also meet or exceed the stringent QA requirements of the ISO/IEC 17025 International Standard General requirements for the competence of testing and calibration laboratories.
We work with you to:
- Develop custom methods (if necessary) and method validation plans.
- Provide release testing for production lots.
- Investigate and provide resolutions for failures and complaints.
- Provide unique cGMP reports to support your Food and Drug Administration (FDA) submissions.
Audits
SGS PSI has an established Internal Audit Program and a Supplier Evaluation Program including an Annual Management Review that provides continuous assessment and improvement of our procedures, processes, and systems. This allows us to maintain our facility in a prepared state of audit readiness, to host any external second or third-party audit. We invite and extend welcome to onsite client audits and any client auditor who may want a first-hand examination of our ISO/IEC 17025 accredited and cGMP compliant facility.
Through our internationally recognized accreditation body, ANAB, our ISO/IEC 17025 accreditation is thoroughly audited and maintained for compliance on an annual basis. We have a proud and satisfactory inspection history that continues to meet the rigorous challenges and expectations of various regulatory bodies including the FDA.
Accreditations
SGS PSI is an accredited and cGMP compliant independent testing lab with several registrations and accreditations including ISO/IEC 17025, FDA Registration, and DEA Registration. Our accreditations and registrations testify to our strong commitment to providing quality testing using great science in a regulated and controlled environment.
SGS PSI was awarded ISO/IEC 17025 accreditation in 2000. In 2007, as a result of increased work with medical device and pharmaceutical companies who strictly follow and rely upon cGMP compliance, SGS PSI became FDA Registered to 21 CFR Parts 11, 210, 211, 610, and 820, as applicable to laboratory testing. In 2008, we obtained a DEA license to receive, handle, and test controlled drug substances and/or controlled chemicals on List I and List II (Schedule 2, 2N, 3, 3N, 4, 5).
Through these accreditations and registrations, we have demonstrated that we operate a robust Quality Management System with technically competent staff who can generate technically valid and reliable results. We are also in compliance with all Virginia Department of Environmental Quality (VADEQ) rules and regulations and are capable of providing ITAR (International Traffic in Arms Regulations) compliance on applicable projects. If you have a project that requires compliance to ITAR or have general questions about our Quality System, please reach out to us.