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For life science companies, compliance with regulatory standards is paramount to ensure the safety, efficacy, and quality of products and processes. One such critical regulation is FDA CFR Part 11, which governs the use of electronic records and...
Tags: FDA compliance software, Quality Management System, 21 CFR compliance, Compliance, fda cfr part 11
Quality management is a critical aspect of various industries, ensuring that products and services meet established standards and exceed customer expectations. As technology continues to advance, the integration of artificial intelligence (AI) is...
Tags: Quality Management System, Compliance, AI, Artificial Intelligence
Quality management is essential in the life sciences industry to ensure the safety and efficacy of products. Whether it's pharmaceuticals, medical devices, or biotechnology, quality management systems help to establish and maintain high standards...
Tags: quality management software, Quality Management System, life sciences
7 Benefits of Implementing a Quality Management System (QMS) in 2023
As businesses continue to adapt to the ever-changing market, implementing a quality management system (QMS) has become increasingly crucial. A QMS is a system that outlines the...
Tags: Quality Management System, what is quality management system, 2023 trends
Researching Quality Management Software for your company can be a time-consuming process. Combing through multiple vendor websites to understand their product offerings, compare features, and determine which may be the best fit for your...
Tags: Quality Management System, pricing, qms
For companies of all industries, keeping the quality of your product and processes high is essential. This means that robust quality assurance is crucial in today’s business world if you want to stay competitive — not only to attract customers but...
Tags: Quality Control Management, manufacturing, Quality Management System, life sciences
For companies in the life science industry, regulators require an official process for managing their corrective and preventative actions (CAPAs). Additionally, a strong CAPA workflow is necessary for audit preparation, maximizing cost savings,...
Tags: Quality Management System, CAPA management, CAPA Workflow, life sciences
Bobbi Lilek
Bobbi works as a Quality Systems Director for a rapidly growing biotechnology company that utilizes the ENSUR software for both Document Control and Quality Management. In order to maintain her company’s policy of strict customer...
Tags: document management software, Quality Management System, FDA Electronic Signature, Quality, audit
For many companies, establishing a Quality Management System (QMS) is imperative as it not only improves overall productivity and quality of products and services, but also ensures compliance. A comprehensive QMS takes a critical look at your...
Tags: quality management software system, training management, Quality Management System, CAPA management
What is Traceability and Why is it Important?
In the manufacturing industry traceability is defined as the process of recording necessary information which is then tracked in all business process from obtaining raw materials and parts to...
Tags: manufacturing, Quality Management System, traceability