GLP Compliance

Labstat’s SOPs and infrastructure are compliant to 21 CFR Part 58.  Labstat has made a significant investment in writing and enforcing GLP compliant SOPs that cover all aspects of its Toxicology, Chemistry, Measures of Exposure and Method Development offerings.  The Company’s Quality Assurance department is well versed in all aspects of GLP and is responsible for ensuring that:

1. All SOPs are documented and compliant with 21 CFR Part 58 requirements;
2. All GLP studies are conducted and audited to GLP standards; and
3. All external audits, Client or Agency driven, are handled in a transparent and knowledgeable manner.

ISO 17025:2005 Accredited

Labstat believes laboratory accreditation (ISO 17025:2005) is of primary importance. It is an objective assessment of a laboratory’s capability and commitment to produce repeatable, defendable and accurate data.

To maintain the integrity of our accreditation and protect the interests of our clients Labstat has created a quality assurance department solely dedicated to complying with these standards. The Quality Assurance Department achieves these objectives by:

1. Documenting compliant procedures for the services we render;
2. Managing the training of personnel in the aforementioned procedures and in the standards we subscribe to; and
3. Conducting regular audits of projects and procedures to ensure compliance .

The audit process is as important to our clients as it is to us. Our clients and Labstat need to be assured that the results we produce are reliable, defendable and supported by audit trails.

Labstat undergoes audits by internal auditors, clients and our accrediting body (Standards Council of Canada). Quality Assurance is mandated to audit all areas of our laboratory to ensure compliance with our quality system. Furthermore, this group routinely audits specific projects to ensure compliance with our documented standards.

Our Quality Assurance staff conducts internal audits according to a specific protocol, as dictated by our standard operating procedures. This involves the actual audit, creation and review of an audit report, a post-audit meeting with the individuals involved, issuance of any requests for corrective actions, development of an action plan for corrective actions, and follow-up and verification of implementation of actions.