ResLabQ&C Ltd
Clinical Research Laboratory
Quality and Compliance
Audit and Assessment
Another crucial component of quality assurance within your facility is regular audit. Both the MHRA and HTA expect regulated establishments to have a system for auditing their activities in an independent manner, to verify compliance with the quality standards and to identify areas where corrective and preventative actions are required to maintain compliance and to drive improvement. At regulatory inspection, you will need to demonstrate that you have this in place.
How can we help?
By employing ResLabQ&C as an independent third party to carry out an audit, you can ensure that the results are impartial and credible. We can conduct audits of facilities or individual studies. We will work with you to agree the scope and standard for the audit and develop a robust audit plan based on your needs. Audits will always be conducted in a sensitive and confidential manner (confidentiality agreements will be put in place). You will receive an insightful and well documented interim report to review for accuracy, and once agreed, the report and remedial action(s) will be finalised.
Good Clinical Laboratory Practice (GCLP) audits will normally cover facility management, quality management (QMS review, training, internal audit), sample receipt, management, and analysis, result reporting, data management, computer systems, and archiving. Looking at all of these activities together will provide assurance that the principles of GCP are being applied whilst also ensuring that the reliability and integrity of the data generated are adequate.
Audits of establishments covered by an HTA research licence will focus on the four standards published by the HTA (Consent, Governance and Quality, Traceability, Premises, Facility and Equipment).
Audits of facilities covered by an HTA application licence are more extensive, with additional emphasis on donor selection and screening, procurement, processing, quality control, distribution, coding, adverse events, and record keeping.
You may prefer to commission a complete audit of all relevant activities (either in one short period or in several phases), or you may prefer to focus in one or more particular area(s) of work. We can tailor the service to your preferences and requirements.
ResLabQ&C also offers an alternative to a formal audit process and can undertake an assessment of compliance within your facility. The assessment will involve a review of your processes, quality systems, and documentation. You will receive a comprehensive report that identifies gaps and provides recommendations tailored to your size and function. If required, we can then assist with the implementation any of the suggested improvements to your quality program.
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