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), we need to ensure that she is authenticated, meaning that no one else was logged in to read the SOP for her. This is a part of individual responsibility in […]
Why a pharma LMS matters in audit trail management
The pharmaceutical industry has stringent regulatory requirements, one of which is audit trail management. An audit trail provides a secure and detailed chronological record of user activities. This is often in relation to the lifecycle of a critical product, as is often the case in pharmaceutical manufacturing. The primary purpose of audit trail management in […]
The 5 Best HIPAA-Compliant Video Training Software Tools
Video conferencing tools, like Dokeos Live, have seen a sudden rise in popularity among healthcare practitioners due to the difficulties many have faced during the COVID-19 pandemic. However, not just any video-sharing tools are appropriate for use by professionals in this industry. The Health Insurance Portability and Accountability Act (HIPAA) sets clear rules for healthcare […]
3 Keys to Training on SOPs in the Pharmaceutical Industry
Training on SOPs in the pharmaceutical industry is critical for success. Follow these 3 keys from Astella Pharma to increase compliance with SOP-led training. Compliance has always been a cornerstone of pharmaceutical excellence. Regulations are in place for a good reason: they protect the public, further medical innovation, and protect your business from liability. However, […]
As Your Pharmaceutical Company Becomes Increasingly Digitized, Make Sure Your LMS Does, Too
The right digital LMS supports your pharma company’s digital transformation. Evaluate your LMS options against these 7 criteria. Digital LMS Supports Transformation of Pharma Industry Pharmaceutical companies are becoming increasingly digitized as they lean into environments that are changing around them. This digitization is a response to opportunities to improve their production processes, analytics, and […]
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 and updated tool in the approach for the validation of GxP computer systems. If computer systems employed in the pharmaceutical industry do not follow GAMP 5 guidelines, they have a […]
How Dokeos Can Help With HIPAA Compliance Training
The Health Insurance Portability and Accountability Act (HIPAA) is a US law that protects patient data and security in the healthcare industry. Since 1996, this law has ensured patients receive the best care possible without sacrificing their personal security. Today, HIPAA requires all healthcare organizations processing Protected Health Information (PHI) to comply with its privacy […]
How To Train Your Employees to Cybersecurity
And suddenly, everything changed. In early 2020, much of the world went into lockdown to minimize the effects of a highly contagious virus. Businesses closed their doors and employees began working from home. Companies had to make rapid and sometimes massive shifts in how they run their operations. Part of this shift involved bringing in […]
Neuroscience Training For Online Training
Boost Retention and Engagement with These 5 Neuroscience Training Methods When your company invests in professional development training—especially with an LMS—you need it to be as effective as possible. One way to get there? Neuroscience. In contrast to the behavioral focus of psychology, neuroscience analyzes the biological processes of the brain. You have little control […]
A Rollout Plan for Your Learning Management System (LMS)
Do you have a learning management system rollout plan? Follow this six-step checklist to plan your LMS launch from goal-setting to post-mortem metrics. A Proven 6-Step Learning Management System Rollout Plan You’ve chosen your learning management system (LMS) and are ready to implement it. But how can you be sure employees will use the LMS? […]
