Quality Management Systems
An organisation’s quality management system should be simple, meaningful and consistent with the relevant standards. It must be flexible to grow with your organisation.
Tower Mains designs bespoke QMS or a QMS development plan for your organisation which is consistent with the principles of GCP, GLP or GMP or for non-regulatory research. We are also experienced in developing Quality Management Systems for Medical Device companies and non-commercial organisations.
The team at Tower Mains has extensive experience in developing and managing Quality Systems for regulatory and non-regulatory systems.
Our experience includes:
- Building regulatory QMS for a new facility
Extending a GLP laboratory QMS to comply with EMA GCP laboratory requirements
- Adjusting a non-regulatory QMS to meet regulatory requirements
- Independent review of an existing QMS against a standard and providing an action plan
Understand
the context of your organisation
Evaluate
current systems and processes
Action Plan
detailing what is required, prioritised
Implement
the action plan
Assess
QMS compliance with independent audit
QMS Evaluation
- Tower Mains can evaluate your current system to identify regulatory compliance deficiencies.
- Our evaluation 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.
Documented Procedure Development
Complementing our QMS consultancy you may just require support with documented procedures. Whether they be the site master file, Quality Manual, SOPs, Work Instructions, forms and templates Tower Mains has the expertise.
Our approach is flexible for your specific needs:
- Mapping processes
- Revising documents to simplify content
Using other technologies for documenting instructions such as video instructions