Blog Home TAG: Pharmaceutical & Biotech Regulatory Compliance

3 Essential Document Control Best Practices for Combination Products

Combination products (CPs) have revolutionized drug delivery and patient care, but their very nature poses unique challenges to manufacturers. When two or more components create a combination [...]


AssurX Solutions Webinar: Implementing Document Management & Training Management Systems

Document control and training management processes are QMS solutions that are strong on their own, but they are even more efficient when they are integrated. Within the quality and compliance [...]


How to Simplify CAPA Management with a Cloud-Based QMS

Corrective and preventive action (CAPA) violations are the most frequently cited non-compliance in FDA 483 inspection observations. In 2020, nearly 200 violations were cited among medical device [...]

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