Consultancy
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
Inspection Readiness
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:
Before inspections:
Mock Regulatory Inspections
- Help to prepare for inspections
- Advice on developing procedures for handling inspections
- Guidance on the step-by-step process
- Identify potential areas of risk (systems and procedures)
Mock Interviews
- Help to prepare staff for compliance Inspectors’ questions
Provide feedback and advice to staff on interview performance
Identify any remedial work required to be inspection ready
- Can apply to individuals or teams
Preparing sites for inspection
- Tower Mains can also help you prepare your documentation and facilities for an inspection.
During an inspection:
Opening Meeting
- Guidance and advice to help ensure you get your inspection off to a good start.
Regulatory Inspection Hosting
- Advice on inspection do’s and don’ts to help you achieve an efficient and successful inspection.
Closing Meeting
- Understanding and clarifying any issues raised by the Inspectors
- Preparing constructive responses
After an inspection:
- Review of inspectors’ findings
- Identification of appropriate corrective actions and preventive actions
- Preparing responses for regulatory authorities and clarifying any issues raised by the Inspectors