Quality Assurance Consultancy has established and implemented more than 100 GLP programs for clients that include the following:
- Research and discovery units required to conduct a phase of or an entire GLP study
- CRO’sand existing or start-up companies preparing to conduct regulatory studies
- Sponsor laboratories requiring an internal GLP quality management system
- University laboratories needing to develop GLP capabilities
- Government laboratories needing to develop GLP capabilities
Our comprehensive solutions and team of specialists support these organizations by helping them:
- Perform gap analysis of an existing quality system, regardless of how developed it is
- Establish a quality assurance unit (prepare QA SOPs, set up file structure, implement reporting format)
- Develop and customize technical and equipment SOPs
- Harmonize SOPs with other quality systems, such as the ISO 17025, OECD and GMP
- Conduct GLP training, basic thru specialized
- Develop and standardize documentation forms
- Assist management and the QAU during implementation
- Assist clients during regulatory GLP inspections
- FM-200™ fire suppression system
- Vesda ® early-warning fire detection system that analyzes air for smoke particles
- Security system with 24-hour monitoring
- Room temperature archiving for:
- Documents and electronic media
- Test/control/reference substances/articles
- Wet-tissue specimens
- Paraffin-embedded blocks
- Microscopic slides
- Retention of samples
- -20 ºC freezer archiving
- 1 to 8 ºC refrigerator archiving
- Temperature and humidity-controlled environment to prevent deterioration
- Limited and controlled access
- In-house developed archive database for prompt retrieval
