All Industry Welcoming the Medical Device Regulation in 2021 May 4, 2025 / October 7, 2026 by Keren | Leave a Comment Standards are necessary to keep things going in a flow. And when it comes to something as important as medical devices, which are responsible for ensuring our health and safety, standardization is necessary. Among the different standardization bodies present today, ISO, BSI, UKAS, and FDA are some of the most important and renowned. EU also […] Read more »
All Industry FDA Guidance on QMS Validation: 4 Major Changes May 4, 2025 / May 14, 2025 by Keren | Leave a Comment QMS validation is critical to your company’s day-to-day management, and its ability to manage complex reams of data is essential for internal and external auditing purposes. Also, your overall competitiveness relies on high-quality data from a superior QMS system. A system that is agile enough to absorb changes is invaluable. The U.S. Food and Drug Administration […] Read more »
All Industry Easy to Deploy & End-To-End Solutions With New eQMS May 4, 2025 / May 14, 2025 by Keren | Leave a Comment We have seen a rising demand for easy to deploy and end-to-end solutions this year that has never been seen in the past. The majority of organizations have started to realize the requirement for quality and compliance systems that are cloud-based, and in recent months those systems have been bulletproof Covid-19 coverage. There are many […] Read more »
All Industry How does automation meet quality standards and ensure operational compliance? May 4, 2025 / May 14, 2025 by Keren | Leave a Comment To err is human; to automate is the solution. This is the era where businesses belonging to any industry are opting to automate their operational processes through technology and software tools. Every industry has its own compliance rules to be met put forward by regulatory bodies such as the ISO and FDA. And striving to […] Read more »
All Industry How can a CAPA management system help to achieve operational excellence? May 4, 2025 / May 14, 2025 by Keren | Leave a Comment CAPA stands for Corrective Actions and Preventive Actions. As the name suggests it consists of two sets of actions: 1. Corrective actions Changes brought about in operation, documentation, and systems to correct undesirable situations that hinder the workflow or reduce efficiency fall under this category. They are implemented in response to customer complaints, issues found […] Read more »
All Industry How To Transition From Paper-Based Quality Management In Pharma To A Cloud-Based QMS solution? May 4, 2025 / May 14, 2025 by Keren | Leave a Comment Most pharmaceutical companies adopt a paper-based or partially electronic method to manage the quality of operational processes, organizational priorities, and compliance with rules. With the FDA and other bodies becoming increasingly stringent with compliance rules and policies, it becomes necessary for pharmaceutical companies- small, medium, or large-scale, to have a systematic approach to quality management. […] Read more »
