Transform Your TMF Management With A Validated LMS

TMF Management

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 […]

Ensuring 21 CFR Part 11 Compliance With Dokeos: A Guide For Quality Control

21 CFR Part 11 Compliance

Since its introduction in 1997, the FDA’s 21 CFR Part 11 has provided rules on the management of electronic records and electronic signatures in the pharmaceutical and biotechnology industries. The latest update was published on October 1, 2024. It provides a guide to using electronic records in clinical investigations, helping stakeholders adhere to good clinical […]

Ensuring Good Distribution Practice (GDP) Compliance With GxP Training

Good Distribution Practices

Between 2020-2023, the U.S. reported 107 medical device recalls; the most common recall was due to quality control. Emphasizing the need for manufacturers to maintain medical device quality and safety throughout the supply chain. Good Distribution Practice (GDP) is a set of international standards and guidelines that protect a medical device’s quality, safety, and efficacy […]

Workplace Safety: OSHA Compliance for Manufacturing Companies

Workplace safety : OSHA

The Occupational Safety and Health Administration (OSHA) has strict standards for the manufacturing sector. The aim is to prevent and reduce workplace injuries and fatalities, many of which are preventable and due to negligence. In fact, there were 373,300 recorded incidences of non-fatal injuries on the manufacturing work floor in 2020, according to a  U.S. […]

Safety and Compliance training in Pharmaceutical Manufacturing

gxp training

GmP guidelines establish compliance and safety standards for work floor operations and product quality assurance. The regulations are set by governing bodies like the World Health Organization (WHO) and the Pharmaceutical Inspection Cooperation Scheme (PIC/S). The guidelines are extensive and can be cumbersome to navigate. Fortunately, training in pharmaceutical manufacturing can be managed on a […]

How to Develop your employees skills in the manufacturing industry?

Innovative manufacturing Training

With the emergence of technology and AI in particular, manufacturing processes are evolving at an unprecedented pace. With this comes new practices on the warehouse and assembly lines. The key is to develop innovative training approaches in a way that’s convenient, flexible, and time-efficient. The solution for fostering employee skills in this manner lies in […]

Boosting Productivity: Integrating LMS with HR Workflows

training with an LMS

Boosting productivity should be at the core of every HR corporate resolution plan. Employees who are productive and maximize their time on the clock impact the company’s bottom line, directly or indirectly. LMS as part of a broader digital adoption initiative can be a significant game-changer in positively changing employee attitudes, confidence, and productivity. Learn […]

Safety and Compliance in Manufacturing: A Guide to E-learning Solutions

Manufacturing and Safety e-learning

Safety is paramount in an industry that involves heavy use of assemblies and machinery. Employee welfare should be at the core of every safety and compliance plan. It starts with education, and the optimal way to get your employees up to speed is via e-learning solutions. Learn how online training fosters adherence to compliance and […]