Achieving Regulatory Compliance – Life Sciences

Quality Management and Regulatory Compliance are core business processes within the Life Sciences environment, with the FDA, the MHRA and the EMEA requiring that products, services and processes are provided and performed in a robust Quality-Assured environment that meets standards such as 21 CFR 820 and GxP.

Many organisations approach Quality Management and Regulatory Compliance in a disjointed manner resulting in a duplication of effort, an increase in unnecessary overheads and ultimately a missed opportunity to gain valuable business advantage from such actions.

Life Sciences organisations across the globe are turning to software systems and support that rid them of the bureaucratic burden of compliance, enabling them to meet their regulatory commitments in a streamlined manner, whilst unlocking the latent business improvement opportunities within their management system data.

FDA and MHRA regulations also require when introducing any new software system into your production environment, you may be required to follow a validation process before the system is live. Gael can provide you with a Validation Project Management Service to assist and support you throughout your validation process.

Whether you are a Medical Device or Pharmaceutical manufacturer, a Biotechnology company, or a Blood Services provider, your organisation need look no further than Q-Pulse.

Regulatory Compliance in Life Sciences – A Holistic Approach

Q-Pulse is a fully integrated compliance management solution that covers regulatory activities such as Auditing, Document Control and CA/PA Management, in compliance environments including ISO 9001, GxP and ISO 13485.

The Q-Pulse Advancement Framework provides a seven-step solution with which you can advance your organisation through regulatory compliance. These seven simple steps can make a lasting difference to your organisation by transforming necessary compliance activities from a costly overhead into a business benefit with proven competitive and commercial advantage.