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:
the context of your organisation
current systems and processes
detailing what is required, prioritised
of the action plan
QMS compliance with independent audit
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:
Preparing for and managing a regulatory or compliance inspection can be very time-consuming. Good, effective preparation will have a significant impact on the outcome of the inspection, so it is well worth taking the time and getting it right.
The Team at Tower Mains helps many clients manage the preparation process for compliance inspections across all sectors, for GCP, GMP and GLP regulatory inspections.
We can provide support throughout the complete inspection process including preparation, hosting and follow-up, or simply assist with the preparation in any area you feel needs attention. This can include conducting mock inspections and interview training.
Inspection Readiness services we offer:
Mock Regulatory Inspections
Preparing sites for inspection
during an inspection:
Regulatory Inspection Hosting