Quality Management Systems (QMS)

TMQA provided wonderful assistance during the initiation of the company; setting up and monitoring the Quality Management System and thereafter actively supporting my membership of the MHRA GLP Compliance Programme.

Managing Director, UK GLP Compliance Programme Member

An organisation’s quality management system should be simple, meaningful and consistent with relevant regulatory standards. It should also be able to grow with your organisation and meet any future requirements – regulatory or commercial – without unnecessary re-working.

The TMQA team has extensive experience working with our clients auditing, developing and managing their Quality Systems. This experience ranges from:

  • Developing a bespoke QMS
  • Gap Analysis of your QMS to help identify areas for improvement
  • Independent audit of your QMS to identify any risks of regulatory non-compliance
  • Acting as your Quality Assurance Unit

Development of a QMS

TMQA can design a bespoke QMS or a QMS development plan for your organisation which is consistent with the principles of GCP, GLP or GMP. We are also experienced in developing Quality Management Systems for Medical Device companies and non-commercial organisations.

QMS Gap Analysis

TMQA can conduct a Gap Analysis of your current systems to help identify GxP compliance deficiencies. All quality management systems include:

  • Organisation and management
  • Planning
  • Delivering the services
  • Measuring and review

Our gap analysis will identify any areas for improvement against regulatory standards or your own quality standards. We can advise on the actions to close the gaps and assist in your continuing review of your performance.

Review of QA systems

The TMQA team can perform an independent audit using standard tools such as checklists, questions and audit techniques to ensure an organisation’s QA function is aligned with the relevant “good practice” standards.

Acting as your Quality Assurance Unit (QAU)

Employing your own Quality Assurance resource can be costly and inefficient. TMQA can provide your full QA and audit services so that you only pay for what you use. Use of external QA resource is recognised and accepted by the MHRA and other international regulatory authorities.