FDA and MHRA Compliance Solutions
Navigating the complex regulatory landscape can be tricky for life science organisations. Compliance with standards set out by regulatory bodies including Medicines and Healthcare Products Regulatory Agency (MHRA), the US Department of Food and Drug Administration (FDA), and the European Medicines Agency (EMEA) require robust processes, management and systems.
A strong quality management system (QMS) protects patients while driving operational excellence. Regulators have long recognised the importance of a quality culture and an effective QMS which assures a state of control, upholds regulatory compliance and drives improvement.
Q-Pulse is a quality management system which is used by hundreds of life science organisations worldwide to meet international standards and regulations, including ISO 13485, GxP, ISO 9001 and FDA 21 CFR Part 11.
Q-Pulse not only supports organisations in their compliance processes and management but provides tangible business insights and improvement opportunities for sustained commercial success.
A System Level Approach Strengthens and Simplifies Compliance
- Management of policies and procedures with full version and change control
- Move data out of paper files, spreadsheets and file servers into a consistent and accessible register
- Anticipate and prevent problems: reduce the probability of process errors
- Generate an audit trail
- Asset and third part management
- Reporting and recording system for managing internal controls and investigations
- Generate a culture of openness and reporting
- Streamline supervision and internal control with staff competency and training tools
- Control access to data for analytical purposes
Q-Pulse makes it easier to achieve compliance with our standards and regulations, providing us with the tools to implement simpler methods and processes to manage quality. It is a user friendly, electronic, QMS solution which is suitable for use in regulated environments, I would thoroughly recommend the product for use at other companies working to GMP standards.
Kevin Bruce, Head of Development Operations at Roslin Cells
Data integrity is a high profile issue in the pharmaceutical industry globally, partly as a result of enforcements, overseas inspections and criminal prosecutions instigated by FDA, MHRA and other European regulatory authorities.
By improving the management of the operational processes involved in clinical trials and other research, the manufacturing of drugs and also contract services such as testing, distribution and packaging, you can dramatically improve the overall performance of your organisation, reduce the risk of non-compliance, prevent failures and damage, and protect your corporate, professional and even personal reputation.
Ideagen's White Paper, entitled 'A Nudge in the Right Direction', discusses a systematic approach to compliance management in the laboratory.