Understanding the Impact of 21 CFR Part 11 on Your Organization
21 CFR Part 11 is the legal framework that controls how businesses handle their electronic documents and signatures. To comply with the FDA’s statutory inspection […]
Technical Controls for Electronic Records and Signatures
The Food and Drug Administration (FDA) has a regulation called 21 CFR Part 11 that specifies requirements for digital records and electronic signatures. It was […]
21 CFR Part 11 : Electronic Signature & LMS compliance
The FDA’s data integrity requirement calls for evidence of authenticity. In other words, when someone—let’s call her Mary—is validated on a standard operating procedure (SOP), […]
Pharmaceutical industries & e-learning: does your LMS follow the new GAMP 5 guidelines?
The fifth version of ISPE’s The Good Automated Manufacturing Practice (GAMP 5) Guide for Validation of Automated Systems in Pharmaceutical Manufacture represents the most recent […]
How a Sales LMS Helps Reps Thrive in a Highly Regulated Environment
A sales LMS helps reps in highly regulated industries stay up-to-date, navigate difficult conversations, and disseminate critical information to clients Sales reps face great challenges […]
Moodlepreneur Monday (er, Wednesday): The Supernatural Powers Of (Part) Eleven (Compliant LMS)
As an educational technologist, chances are you are not in this field out of your love for data traceability or your passion for ensuring your […]
Training external partners in the healthcare sector
What are the key objectives when training external partners? Reducing risks, improving quality of care, and engaging patients to cut costs. Healthcare sector: 3 key […]
8 tips to improve your GMP online training for medical device and pharmaceutical companies
QA guidelines, strong compliance culture, microlearning, branching scenarios and feedback are key ingredients to improve quickly your GMP online training. Is your Quality Assurance online […]
Training external partners in the healthcare sector
What are the key objectives when training external partners? Reducing risks, improving quality of care, and engaging patients to cut costs. Healthcare sector: 3 key […]
2016, the year of compliance e-learning
With the New Year comes new resolutions. Compliance e-learning will be increasingly popular in 2016, helping you turn promises into action! The post 2016, the […]
What does the Food Safety Modernization Act mean for your business?
If you’re in a food-based business, you know how important food safety is. Foodborne illnesses cost businesses over $75 billion each year. In the past, […]
Business case: assuring training standards in pharma
Dokeos has published a new business case on how Astellas Pharma ensures its teams training standards at the right level. The post Business case: assuring […]
