QMS Development & Licensing
If you wish to apply for new licences or expand into new GxP areas you must first ensure that you have a robust Quality Management System (QMS) appropriate for the type of operations prior to changing activities or initiating the licence application process. Orion Consulting can help you design and implement effective quality management systems that comply with current EU and UK GxP standards.
An effective QMS will consist of all of the business processes, personnel responsibilities and standards including manuals, policies and procedures required to ensure that regulated processes are carried out in a controlled manner and ensure the manufacture of high quality, safe and effective products. We work with our clients to develop a bespoke set of QMS documentation that is written with all your company proposed facilities, products and manufacturing or business processes in mind. We then follow up to ensure that the written processes are trained out and can be effectively implemented and bedded in at your manufacturing and distribution facilities.
One benefit of designing and implementing an effective and comprehensive QMS is that it provides consistency. So that every time a process is completed, it is carried out in the same way and to the same high standards. This will mean that employees can access the Standard Operating Procedures (SOPs) and get detailed instructions on how to carry out each task without any deviation from the expected highest standards of research, investigation, reporting and documentation. An effective QMS will also ensure compliance with the relevant competent authority, notified body, corporate standards and regulatory GxP standard to be applied.
Orion GXP Consulting can assist from the outset in designing and implementing your QMS, in supporting an existing QMs and also as part of remediation where deficiencies have been noted by competent authorities.
