GMP training management in pharmaceutical companies
GMP training for automated systems to manufacture products
Current Good Manufacturing Practices (GMPs or CGMPs) compliance by pharmaceutical companies is key to producing regulatory-compliant products. It means all employees become and remain aligned to safety standards.
Most pharma rely on automated systems to manufacture products. Hence the need to include the risks linked to automation in a Good Automated Manufacturing Practice set of rules, also called GAMP5.
- A Risk-Based Approach to Compliant GxP Computerized Systems
- Electronic Data archiving
- A Global Information Systems Control and Compliance.
GMP training with a regulatory compliant LMS
Therefore, GMP training needs to validate:
- the employees standardized manufacturing skills
- the electronic system used to train them.
If this system is a LMS (Learning Management System), it needs to be a regulatory compliant LMS able to ensure full traceability with features like:
- Electronic Signature
- Individual Training Files and
- SOPs (Standard Operating Procedures) management
Case study: GMP training at Adents
The Adents company is a fast growing company. It has developed an innovative traceability solution applicable to drugs transport, storage, identification and authentication that enables you to track an unlimited volume of products worldwide.
To ensure their GMP compliance at all levels of decision, action and automation, the Adents Quality Management department has selected the Dokeos LMS solution so to include the training process in the overall traceability process.
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