Quality Systems
An organisation’s quality system should be simple, meaningful and consistent with the relevant standards. It must be flexible enough to grow and adapt with your organisation.
Tower Mains designs bespoke quality systems or a quality system development plan for your organisation which can be consistent with the principles of GCP, GLP or GMP as well as adapting to a wider quality framework such as ISO standards (e.g. ISO 9001). Our expertise also includes developing quality systems for medical device companies and non-commercial organisations.
The team at Tower Mains has extensive experience in developing and managing fit-for-purpose quality systems across both regulatory and non-regulatory systems.
Our experience includes:
Building regulatory quality systems for a new facility
Extending a GLP laboratory quality system to comply with EMA GCP laboratory requirements
Adjusting a non-regulatory quality system to meet regulatory requirements
Independent review of an existing quality system against a standard and providing an action plan for regulatory compliance
Our standard approach includes the following steps:
Understand
Gain a deep understanding of the context of your organisation its objectives, operations, stakeholders, and quality expectations.
Evaluate
Assess your current system and processes to identify gaps and opportunities for improvement.
Action Plan
Develop a prioritised action plan outlining what is required to achieve compliance and strengthen your quality system.
Implement
Tower Mains will support you in implementing the action plan across your organisation.
Assess
Verify quality system compliance with an independent audit.
Quality System 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 performance review.
Documented Procedure Development
Complementing our quality system consultancy, you may just require support with creating or maintaining documented procedures. Whether they be the Site Master File, Quality Manual, SOPs, work instructions, forms and templates – Tower Mains has the expertise in fit-for-purpose, easy-to-use documentation.
Our approach is flexible and tailored to your specific needs:
Mapping processes using custom, organisation-specific diagrams
Revising existing documents to simplify content
Developing fit-for-purpose SOPs and controlled documents
Using other technologies for documenting instructions such as video-based guidance