Assessing Compliance
"Success is not an accident. It is a direct result of Quality!"
WQATS specializes in assessing and developing quality systems for:
- Good Clinical Practice Audit
- Vendor Qualifications
- Good Manufacturing Practice Audits
- Good Laboratory Practice Audits
- Training (Management & Employees)
- Contract Lab Audits
- SOP Writing
- Batch Records Review & Release
- Developing Corrective Action Plans
- Hosting FDA and HPB Inspections
Clinical Research
Clinical sites and investigator site files are audited to ensure investigators and their
staff observe Good Clinical Practices including adherence to the Declaration of
Helsinki and industry driven good documentation practices when conducting clinical
trials.
Manufacturers
Auditor’s experiences include auditing large and small manufacturing companies to
assess compliance with regulations regarding laboratory facilities, batch records,
product release, sample retention, stability program, and packaging procedures.
Clinical Research Organizations (CROs)
Sponsors invest millions of dollars when they delegate clinical trials responsibilities to
CROs. It is good business sense to qualify the CRO and through auditing, WQATS
ensures there are procedures, trained personnel and adequate resources for the
CRO to perform delegated tasks.
| So, how's your Quality? |
Auditing
The domains of Clinical Governance, extracted
from 'What is Clinical Governance' - N. Starey,
(Director, Centre for Primary Care, University of
Derby), Evidence-based Medicine, Sponsored by
an educational grant from Aventis.
http://www.evidence-based-medicine.co.uk/ebmfile
s/WhatisClinGov.pdf
from 'What is Clinical Governance' - N. Starey,
(Director, Centre for Primary Care, University of
Derby), Evidence-based Medicine, Sponsored by
an educational grant from Aventis.
http://www.evidence-based-medicine.co.uk/ebmfile
s/WhatisClinGov.pdf
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