Quality Management Systems
Our QMS Consultancy is aimed at optimising systems to ensure high quality output. Our experienced team will review your existing QMS to identify gaps and work with you on solutions to nullify the deficiencies.
Assess the effectiveness of your quality management system
Assess the level of compliance
Advise on quality and efficiency improvements
Find out how ADAMAS Consulting can help with your next project
Recent examples of our work:
Deconstruction of global clinical operations and organisational structure to assess reasons for delays in workflow processes, poor quality work and communication failures.
Identified gaps and aligned the quality management system across functions. Developed metrics to monitor quality of the output on an ongoing basis, resulting in increased operational efficiency.
Advised company new to the regulated pharma industry on how to develop and implement a fit for purpose QMS
ADAMAS can provide a range of services to help you to optimise your QMS (SOPs and associated Forms and Templates) and thus improve regulatory compliance as well as efficiency.
Our services include:
- Design and creation of a new QMS (for a function, department or whole organisation)
- Independent evaluation of an existing QMS to assess compliance with current regulations and guidance
- Restructuring and updating the QMS to simplify it and improve compliance
- Consolidation of QMS from two or more companies or complete re-development of the QMS following Mergers and
- Acquisitions or other organisational change
- Globalisation of existing country specific QMS
- Localisation of existing global QMS
We work in all geographies and across all GxPs (GCP, GVP, GcLP, GLP and GMP).
In addition, ADAMAS also has experts that can help you with the development, review or revision of the QMS pertaining to computer systems life cycle development, as well as computer systems validation and deployment.
Irrespective of the GxP and geography, our consultants will work with you to understand your environment and provide you with solutions that are best suited to your requirement and are compliant to applicable regulations.
Companies performing clinical development internally are becoming increasingly concerned about whether their systems are working efficiently and are compliant with current regulatory requirements. There have been many changes in clinical trials legislation over recent years which have increased the complexity of clinical development and commanded more resources. One of the challenges companies face is being able to meet regulatory expectations with limited resources, whilst remaining competitive.
The success of a clinical trial, or a positive outcome from a regulatory inspection, is dependent on the effectiveness of the quality system in place.
ADAMAS Consulting has a team of highly experienced and knowledgeable consultants who can independently and objectively assess existing quality systems to identify gaps or deficiencies. The Consultants provide valuable input into optimising systems to ensure a high quality output.
Thank you for your time and all the hard work you have put in over the last couple of days. I believe it was very productive and a worthwhile exercise. We are compiling all action points now, thank you for your speedy response and summary. We envisage quite a busy time ahead.
If you've got any questions or queries about our services, careers, or training, please get in touch.
We have 500+ years combined experience, working around the globe there isn’t anything we’ve not encountered in our sector. We're very approachable and happy to help.