What is a validated LMS ?
FDA 21 CFR 11.10(a) explains that a validated system is required to guarantee the accuracy, reliability, and consistency of electronic records and processes. For pharmaceutical companies, validation is a non-negotiable requirement. How are systems validated? Does training content need to be validated? This article unpacks the following subjects: Let’s dive in. What is a Validated […]
How to build a Training program that meets FDA Standards? A Comprehensive Guide for Quality Managers
The global pharmaceutical industry is estimated to reach $1.6 trillion in 2025. Ensuring regulatory compliance for industry operations is essential for safeguarding patient health and maintaining operational efficiency and reputation. The importance of regulatory complaint training cannot be understated in pharmaceutical operations. In this article, our quality experts detail how quality managers can build training programs […]
Master TMF And ISF Management: Training For Regulatory Compliance Success in Clinical Trials
Clinical trials are known to be both time-consuming and costly, with delays setting back a CRO an average of $40,000 daily. Regulatory compliance and data management are common causes of trial delays. At the foundation of data integrity and compliance is the Trail Master File (TMF). Properly maintaining these files can determine whether a drug progresses […]
Choosing the right LMS for a CRO: meeting regulatory demands and enhancing training efficiency
The latest market research predicts that the LMS market will reach a value of $28.1 billion by the end of 2025, with adoption rates in North America of 70% from 2020. In other words, e-learning platforms have become essential to the life and growth of a company. For the pharmaceutical Industry? Even more so, especially for the […]
Clinical Trial Training: Ensuring GCP Compliance with Dokeos LMS
Clinical trials must be conducted with due diligence and adherence to good clinical practices (GCP). This is non-negotiable and is for the well-being of the patients and test subjects who are entrusting their safety to your hands. GCP compliance doesn’t begin in the lab or clinic. Rather, it begins in the office or at home […]
