Pharmaceutical, food manufacturing, bio-technology, medical device, clinical laboratories and other life sciences organisations operate under intense regulatory scrutiny and an on-going 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 organisations use AITalent’s validated electronic Learning Compliance Solution (LCS) to deliver SOP and GxP training compliant to FDA’s 21 CFR Part 11 guidance for electronic records, documents and signatures.
AITalent’s Learning Compliance Suite streamlines processes and helps to 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
- Centralise 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 organisations
- Integrate with quality or document management systems