Recent Projects

hallgrimskirk in Iceland

Contact information:

Tel: +44(0)7720-446015 / +44(0)1828 898 157

Email: jvb@hunterbirnie.com

Reykjavik Newtyle Den Elie, Fife

QA Consultancy

Cost Effective, Expert Services

Quality Assurance and Audit

For various reasons a company might welcome an alternative to full-time in-house permanent QA, or might require additional QA resource during workload peaks, or to meet project development deadlines.

We can provide GLP and GCP QA services as and when needed, including Locum QA.

If you are anticipating a statutory regulatory GCP inspection, we can undertake a "Mock Inspection" to assess your readiness.

We audit facilities, specialist systems, vendors, project management, computer systems validation, clinical trials (sites and data), GLP Test Facilities, GLP studies, IT operations, IT security.

Audit of In-House QA Programme, to meet UKGLPMA Expectations:

GLPMA EXPECTATIONS FOR AUDIT OF THE QUALITY ASSURANCE PROGRAMME (2-page pdf file)

GCP Audits

We can conduct audits to provide or to supplement your QA programme. Recent audit projects have inlcuded routine site audits, pre-FDA inspection audit, CRO selection and approval audits and computer systems audits.

Project audits inlcude protocol, CRF, investigator site, TMF, laboratory, database, report. Systems audits include data management, IT, IMP handling, Pharmacovigilance, CRO management, records management, report production.

IT Audits

Are you an IT vendor or user operating in a regulated environment?

We offer IT audits for compliance with requirements of GLP, GCP or GLP regulations and 21 CFR 11 and data protection act advice.

Alternatively, we can assist you in implementation of appropriate standards and procedures to facilitate your compliance, or even to assure customers of the integrity of your software product (for instance, validating spreadsheets).

Quality Management Services

We can help you to understand the rationale and scope of application of different quality and accreditation schemes to select the system that is right for your organisation. Thereafter we can lead or manage an implementation project, or be on-hand to provide mentoring and support to internal personnel.

Do you:-

  • need SOPs and have none?
  • need some SOPs but have too many?
  • have an SOP system that no longer works for your organisation?

SOPs and written standards are the backbone of any quality system. We can help you to develop standards and procedures that are relevant and practical, or re-engineer an SOP system that's no longer useful.

Quality Management Technical (QMT) Services

We can provide key technical support on-site, that allows scientific staff to focus upon their primary responsibilities.

QMT services include:-

Quality Management Staff

Our staff have nearly 30 years' international experience in development design and direction of research QA programmes in the pharmaceutical, biotech and contract research industries and have provided independent services since 2000.

Our expertise and understanding of business needs have been appreciated by young and emerging companies. Equally important is a pragmatic approach that we have been told is reassuring to scientific organisations and has been welcomed by personnel for whom implementing quality control and quality assurance has been a new experience.