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 […]
10 ways Dokeos LMS ensures 21 CFR Part 11 and ISO 13485 compliance
Merely complying with FDA (21 CFR Part 11) and ISO standards is not enough – it is the foundation of consistently delivering safe and effective medical devices while leading the field in innovation and trust. Are your training and quality management systems aligned to guarantee compliance? Do you own (or manage) a medical device company […]
Empowering Medical Affairs Teams with E-Learning
Since 2020, the medical affairs industry has grown, with 40% of pharmaceutical companies increasing their medical affairs budgets. These teams play an important role in the medical industry as they bridge the gap between clinical development and commercial operations. Making sure healthcare professionals (HCPs) and other relevant stakeholders receive accurate and up-to-date information. How have […]
From Compliance to Efficiency: How SOPs Drive Pharmaceutical Manufacturing Quality and Consistency
It is said that human error may be responsible for more than 80% of process deviations in pharmaceutical manufacturing. Consider the challenge of producing pharmaceutical products that are high-quality and consistent in the absence of standardized procedures. The result? A recipe for avoidable expenses, miscommunication, human error, and non-compliance. Standard Operating Procedures (SOPs) are critical […]
Identifying the Best Learning Management System (LMS) for Life Sciences
Learning Management System (LMS) have become essential to the daily life and growth of life science companies, ensuring compliance, improving training outcomes, and streamlining processes. The latest market research projects the LMS market is expected to reach a market value of $51.9 billion by 2028. With increasingly complex and stringent regulations, how do Life Sciences companies […]
Medical Affairs: Building Secure, Compliant and Efficient Prescriber Training with Dokeos LMS
Prescribing is a complex task that requires HCPs to be equipped with the necessary skills and knowledge to prescribe medical products effectively and without bias. Prescribing decisions directly impacts patient outcomes, highlighting the imperative for continuous education and ongoing support for healthcare professionals (HCPs). Studies describe how HCPs are more likely to prescribe a particular […]
Training Management System (TMS) Vs. Learning Management System (LMS)
The pharmaceutical and biotechnological industries are accustomed to change. Regulatory updates, new trends, and emerging information are a constant in this industry. In 2024 alone, the CFR Title 21-Food and Drugs saw approximately 229 section updates, emphasizing the importance of keeping employees informed and trained. What software applications—platforms—are available to address your organization’s training requirements […]
Effective GMP Compliance: Ensuring Quality Control in Pharmaceutical Manufacturing
In the manufacturing sector, GMP, or Good Manufacturing Practices, is more than just a buzzword. It’s a set of protocols and operations that should be company doctrine for all businesses involved in the pharmaceutical manufacturing, testing, and release of end-user products. Find out how to implement and enforce GMP compliance and promote quality control. The […]
Transform Your TMF Management With A Validated LMS
The clinical phase accounts for 69% of overall R&D costs, resulting in a need to try to reduce costs. An area that can keep a trial on track both time-wise and financially is addressing delays due to compliance inadequacies. In other words, effectively managing your Trial Master File (TMF) can mean the difference between trial […]
