What is Gap Assessment? Gap assessment and remediation are an essential aspect of any quality management system. . This includes identifying process and procedure gaps
Among the most significant elements of a quality management system in any regulated industry (pharmaceuticals, biotechnology, medical devices) is inspection readiness and gap assessment. Companies
Clinical trials are a key part of medical breakthroughs as they enable the development of new treatments and therapies. However, they soon become labor intensive
Technology has and still is changing the face of medical devices, with servicing being at the very center of these complex creatures’ lifecycle. Serving of
The purpose of an internal audit is to assist regulatory compliance and continuous improvement in a company. Internal audits are resource consuming, and it requires
Currently, globalization has brought with it a transformation in the business of both pharmaceutical and biotechnology industries to execute multi-country clinical trials as a concrete
Introduction To remain agile in the life sciences industry, it is a business necessity to keep one step ahead of changing regulations. Pharmaceutical, medical device,
The medical device industry is a critical partner for providing innovative patient-centric solutions that improve outcomes and will be the device industry model for value-based
This is no walk in the park with life science companies working within a backdrop of constantly changing scientific discovery, strict regulatory requirements and stiff
Pioneer Work in Cell and Gene Therapy: FDA Releases Important Potency Measurement Guidance The newest FDA advancement for Cellular and Gene Therapy (CGT) space is