Most Common GMP Citation for Supplement Producers: Not Establishing Specs

A few weeks ago, the Rocky Mountain Dietary Supplement Forum saw who’s who of the dietary supplement industry converge in Boulder, Colorado. According to this article by Josh Long of Natural Products Insider, numerous FDA officials gave presentations regarding their experiences and noted that failing to establish specs is the most common GMP citation in[…]

User Requirements Specification – Manufacturing Software Validation

A User Requirements Specification (URS) document may be created for all new or replacement computerized systems as defined in the Software Development Life Cycle document and may also provide the basis for the system design and Process Flow Diagrams. The purpose of the URS is to define the company’s interpretation of the projected users’ solution[…]