HunterBirnie

Expert Auditing Services

There's a lot more to a Quality System than auditing – but audits remain a key element.

  • Are you auditing at the right time?
  • Do audits meet their objectives?
  • Do you need help in dealing with audit findings?
  • Are you getting the best value from audits?
  • Are you assured of adequate corrective and preventive action in response to found deviations from required GxPs and agreed standards?
We can prepare a plan for an individual audit, for an entire clinical trial project, or work to your audit plan, if preferred.

"Excellent work."

- Vendor Qualification Audit, Director of QA and Regulatory Affairs

We conduct routine, non-routine and for-cause audits in many areas governed by Good Clinical Practice, Good Laboratory Practice and Good Manufacturing Practice, for example:

Master File audits : Our renowned TMF audit service - building on 14 years’ solid experience of TMF audits, has assessed numerous electronic (e-TMF) paper or hybrid TMFs, as routine and for-cause compliance audits and as part of regulatory inspection preparation.

We have expanded this service to auditing other master files – for example Product Specification File (PSF); Sponsor Oversight File (SoF)

Contractor or vendor qualification audits: GCP, GLP and GMP Laboratories

Systems Audits, for example Data Management, Biostatistics, IMP management, IT, Records Management, Regulatory Affairs, Project Management. Audits conducted at CROs/vendor sites, internally within Sponsor organisations – and some-times cross-function and focusing on interface areas.

Project and study audits, for example clinical trial investigator sites, clinical safety and endpoint analytical laboratories, Phase I, GLP study conduct or reporting, IMP stability studies.

Responding to an audit

Do you need help to respond to an internal or external audit?

The value of an audit is rapidly eroded if there is no process to deal with or understand how to deal with audit findings.

Recent feedback from regulatory inspectors, as well as growing Data Integrity guidance, is a reminder of the need to do a much better job in taking action in response to audits, both corrective and preventative action.(CAPA)

If you need help in handling and responding to audits, please contact us.