It's not possible to write a universal prescription for quality in the pharmaceutical industry, especially when the industry is in an active state of change. The standards which work for a mature enterprise with
Quality Management System (QMS) Coordinator: They develop and maintain a company’s quality management system, making sure that it is consistent with international standards. Future of Quality Control Quality control is the process of ensuring that products and services meet certain standards before the...
Don’t confuse the QMS with QMS software. A QMS is a set of processes and procedures — and many QMS are still based in pen and paper or ad-hoc spreadsheets. But organizations are increasingly digitizing quality management software, also known aseQMS Software. ...
CQ has all the functionality needed in support of a global QMS. Implementation includes: Document control, change order, personnel training, NC/CAPA, equipment management, supplier management, audit management, and customer complaints, all on a single platform. As a small biologics company, it was...
Here are some key elements that businesses can look for in an excellent contract manufacturer: Industry Standards and Compliance An international standard, ISO 9001, outlines the basic requirements for a quality management system (QMS). It is excellent for companies to develop effective, structured, ...
Greenlight Guru is one of the best QMS software systems for medical device start-ups.Why? It's one of the few QMS companies operating exclusively in that niche, and therefore offers a range of dedicated eQMS features for managing documents, training, design controls and other activities for ...
Keep the Heart of QMS Robust: Master How to Ensure Effective Corrective Action in the CAPA ProcessCAPA Program Requirements, Analysis and Implementation The concept of CAPA was initially introduced by the Food and Drug Administration in 2006 as part of the Quality Systems Guidance. This formed ...
Annex B of the ISO 13485:2016 standard includes a comparison with ISO 9001 for reference. Importantly, neither can be used to make a QMS that is automatically compliant to the other and both need auditing. Further, there are many terms in ISO 13485 unique to medical devices. ISO 13485 also...
Pharma 4.0 is the term coined by the International Society of Pharmaceutical Engineering (ISPE) that describes the Industry 4.0 shift towards advanced technology including AI and machine learning, cloud computing, and the Internet of Things (IoT). In a pharmaceutical context, these technologies increas...
What is Big Business ERP vs. Small Business ERP In the past, “big business ERP” addressed large organizations that often deployed onsite/on-premise ERP solutions and had an abundance of resources to dedicate to IT and other support to analyze, customize, upgrade and deploy their software solu...