In many industries, leaders have traditionally viewed a quality management system (QMS) as an additional burden and cost on a business – ‘quality’ owned the system.  This view is still widespread from where standards are necessary to where they are not. Often the mantra ‘it is only R&D therefore quality doesn’t apply’ being the norm and acceptable practice. However, due to significant errors within scientific and non-scientific organisations in recent times which have reached national and international headlines, quality has become high profile. This has led to more calls for establishing quality systems where previously there was no appetite for one. 

TMQA`s technical toolkit on Quality Management Systems in Non-Regulatory Areas is a practical guide to help you get started with designing a QMS bespoke to your organisation`s business and regulatory needs.  Download a copy by clicking on the link below.

This month’s regulatory news update includes:

• EMA Issues Guidance for Industry to Prepare for the UK’s Withdrawal from the EU
• FDA Publishes Draft Guidance on Use of Electronic Records and Electronic Signatures in Clinical Investigations
• MHRA Updates Information on when a CTA is Needed

This issue of our regulatory news update includes:

• MHRA publishes guidance on common issues with Clinical Trial Applications
• FDA publishes updated Compliance Pogramme Guidance Manual
• EMA and Head of CAs discuss consequences of Brexit

TMQA is delighted to announce that Cate Ovington joins us next week as a Principal Associate. Cate has more than 17 years` experience in research Quality Assurance including GLP, GCP, HTA, ISO 9001 and ISO 17025. Cate will be based in England to provide local support for our expanding client base.  Cate`s full profile will be available next week.