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:
- All SOPs are documented and compliant with 21 CFR Part 58 requirements;
- All GLP studies are conducted and audited to GLP standards; and
- 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
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
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.
- Documenting compliant procedures for the
services we render;
- Managing the training of personnel in the aforementioned procedures
and in the standards we subscribe to; and
- Conducting regular audits of projects and
procedures to ensure compliance .
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.