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2nd May 2012

Gael advice: Why is Quality and Compliance important across the life sciences sector?

Why is Quality and Compliance important across the life sciences sector?

Quality Management and Regulatory Compliance are core business processes within the Life Sciences sector. Whether your company operates within the Pharmaceutical, Medical Devices, Stem Cell, Research or Biotechnology sectors, regulatory bodies including the FDA, AABB, EMEA and the MHRArequire that your products, services and processes are provided and performed in a robust Quality-Assured environment.

Achieving and effectively maintaining regulatory compliance is vitally important, and the consequences of not doing so are huge.  In addition, as more and more life science organisations are outsourcing activities to specialised companies e.g. Clinical Research Organisations, external labs, service organisations or partnership companies, any non-compliance by an outsourcing company could also compromise the activities of the organisation.

Compliance activities such as Document Control, Audit Management, Staff Training and Supplier/Asset Management, all require to be effectively managed; however, ensuring your regulatory requirements are being met is not just about these activities.

What should you do to help ensure your compliance requirements are met?

  • Build a Relationship with the Regulator – they are not something or someone to be feared! He/she only has a job to do.  Early engagement with the regulatory body should be encouraged and will build a rapport.  A positive approach works wonders and planning for success is key.
  • Practise effective People Management – Engage your staff in the Auditing process, so that everyone is aware of what they should be doing and where everything is.  Senior management commitment and support is also key – they should lead by example.  Your staff selection process is also important, as is on-going Training and Performance Management – this will enable all your staff to be fully prepared if and when an audit takes place.
  • Keep up with Regulatory Changes – be aware of what you need to comply with, and the consequences if you don’t.  Compliance is important for patient safety and business reasons.  There are human and business consequences to getting it wrong.
  • Implement an effective and reliable Quality Management System (QMS) – a process that works for you and your company will enable you to effectively manage your quality procedures in order to achieve and maintain regulatory compliance.
  • Collaboration is Key – Not only between other life science companies, any fresh thinking or best practice does not necessarily have to come from the life sciences industry, and could be incorporated into your current processes to enable you to perform more effectively.  Companies should be encouraged to push the boundaries with quality not just the science.

About Gael Ltd

Since 1992, Scottish software company Gael Ltd has developed solutions to manage quality, safety, and risk to encourage organisations to focus on what’s important.

Within the Scottish Life Science sector, Gael works with organisations such as Roslin Cells, Symbiosis Pharmaceuticals and Hycor Biomedical, helping and supporting them in demonstrating compliance to auditors, customers, regulators and third party organisations as required.  A member of the Scottish Life Sciences Association, Gael is also involved with the Scottish Academic and Healthcare sectors, helping to facilitate cross-sector collaboration in working together more closely and effectively.

Gael’s Quality Management solution, Q-Pulse, helps life science organisations across the world successfully meet and maintain their regulatory requirements, helping to increase efficiency and productivity, and reduce the time and cost spent managing compliance.