FDA Compliant SOP Training Management

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

Leading life sciences organizations around the world use Cobent’s validated electronic compliance training management system 'LCS' to deliver SOP and GxP training compliant to FDA’s 21 CFR Part 11 guidance for electronic records, documents and signatures.

Cobent’s compliance training software solutions for the life sciences streamline processes and help ensure "audit ready" FDA regulatory compliance by enabling you to:

Create training from current approved SOP documentation
Quickly publish online learning courses and assessments
Manage e-documents using revision and workflow controls
Track on-the-job training, competencies and proficiencies
Capture evidence of training with e-signatures and audit trails
Centralize and track all GxP, GMP, GCP and GLP training
Ensure FDA compliance with 21 CFR Part 11 for electronic records
Automate re-training or re-certification notifications and alerts to users
Automatically assign and notify users of SOP and procedural changes
Accelerate knowledge transfer across sales and marketing organizations
Integrate with quality or document management systems

To learn more, contact us by calling +44 (0) 1932 268 349 or email info@cobent.com.

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FDA Compliant SOP Training Management

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