The FDA’s Case for Quality initiative seeks to shift the focus from validation as a check-the-box regulatory activity to one that centers around quality. The shift will ensure that patients and end users have access to safe, effective care. Recognizing that innovation drives continuous improvement, which, in turn, leads to higher quality and efficiencies in products and… Read More

There are a number of features of artificial intelligence (AI) that make it well suited for use in software validation. Some of these features are its capacity for pattern recognition and the ability to learn and adapt continuously. An emerging use for AI is in laboratory information management system (LIMS) validation. A LIMS is instrumental… Read More

The goal of a manufacturing department is to get the product out the door on time and within specifications. With large batches of products being produced, some sort of quality management system (QMS) is needed to ensure the best and most compliant product is delivered to consumers. A QMS may start out as a paper-based… Read More

In today’s corporate landscape, Learning Management Systems (LMS) play a pivotal role in delivering, tracking, and managing training programs. The LMS supports an organization’s overall regulatory compliance by tracking the needed certifications of all employees and ensuring that records are centralized. Ensuring the dependability, security, accessibility, and adherence to regulations of an LMS is crucial… Read More

Good manufacturing practices are the underpinning of every life sciences business. At the heart of the organization, ensuring end user safety is everyone’s goal. In many organizations, the quality management system (QMS), learning management system (LMS), and manufacturing execution system (MES) work together in service of this goal. This blog describes the essential functions of… Read More