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 […]
Selecting a validated LMS for manufacturing: ensuring SOP compliance and workforce training precision
The global pharmaceutical industry generated $576.64 billion in 2024 and is projected to grow to $929.9 billion by 2030. While these metrics highlight the sector’s rapid expansion, patient safety remains the top priority. Calling attention to the need for manufacturers to prioritize risk management, quality assurance, and safety protocols. How can manufacturers take advantage of […]
The Importance of LMS Validation in Enhancing GMP Training in the Pharmaceutical Industry
What happens when Good Manufacturing Practices are ignored? Between 2013 and 2022, inspections revealed over 1,400 deficiencies, with hundreds classified as major or critical. These findings emphasize the urgent need for thorough training and compliance in pharmaceutical manufacturing. To meet regulatory requirements, companies must provide employees with precise, up-to-date training while keeping detailed records for […]
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 […]
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 […]
5 Best Practices For Managing Training Records In Medical Device Manufacturing
So far, in 2024, there have been 100 medical device and radiation-emitting product recalls, highlighting the ongoing challenge medical device manufacturers face in maintaining device quality, safety, and efficacy post-approval. How do you prioritize quality throughout the supply chain? Through training records. Medical device companies must establish protocols to identify employee training requirements and to […]
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 […]
