Life Sciences & Biotech

Manage training and competency processes to meet FDA & MHRA compliance requirements.

Food manufacturing, pharmaceutical, biotechnology, medical device, clinical laboratories and other life sciences organisations operate under intense regulatory scrutiny. There is an ongoing need to ensure total quality management for good manufacturing, clinical or laboratory practices and compliance. Delivering FDA and MHRA compliant training and well-documented Standard Operating Procedures (SOPs) is key to ensuring business success and compliance with FDA and MHRA regulations.

Leading life sciences organisations around the world are using our Compliance Training Management and Learning Management Systems (LMS) to deliver FDA and MHRA compliant training programmes. Our systems have been built from the ground up to provide the level of granularity and security needed to meet regulatory requirements.

Cobent’s signature product, Learning Compliance Suite (LCS) follows FDA’s 21 CFR Part 11 guidance for electronic records, documents and signatures.

Cobent’s Life Sciences solutions automate training processes and ensure regulatory compliance by helping you:

Create, deliver, track and manage training across your organisation
Centralise the management of all training types: e-learning, classroom, blended and on-the-job
Automate training against individual employee training plans
Implement a closed-loop approach to your quality management processes
Automate the management of SOP and document training to ensure employees are up-to-date on relevant policies
Centralise and track GxP, GmP, GcP and GLP training and initiatives
Store training documents and records through time stamped audit trails, e-signatures and validation
Ensure FDA compliance with 21 CFR Part 11 for electronic records and signatures
Automatically update training plans based on SOP and procedural changes
Accelerate the distribution of knowledge and training across sales and marketing organisations

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Life Sciences & Biotech

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