By Varun Venkatachalam and Jim Morris, IQS Consulting This is the second article in a three-part series on electronic quality management systems (eQMS) in pharma and biotech. The first article addressed selection of an eQMS. It examined the current eQMS landscape, argued that platform selection is a strategic quality decision rather than an IT or […]
By Varun Venkatachalam and Jim Morris, IQS Consulting The transition to electronic quality management systems (eQMS) has been ongoing for a few decades with several main providers and a host of smaller providers. Large companies gravitate to the larger well-established systems while smaller development-stage or midsize companies will choose from a wide selection of providers.1 […]
By Jim Morris, IQS Consulting; and Peter Savin, Beyond GMP Compliance There are two recent developments in our industry that constitute a seismic change in the way pharmaceutical manufacturers are regulated and, consequently, define what we in industry need to do. Firstly, there have been significant staffing cuts within FDA and other government agencies. CDER […]
By Jim Morris, IQS Consulting On occasion I have been asked by manufacturers with multiple sites to help improve their investigations program, with particular emphasis on reducing “error” rates. Without going into too much detail, I’ll share some of the learnings and recommendations. Often sites will still be paper-based and gradually moving to electronic systems […]
By Jim Morris and Don DeRoo You’ve completed the CDMO selection process and identified the firm that will help you bring your product to the market. The CDMO’s leadership team is experienced, knowledgeable, and eager to work with you. But working with a CDMO doesn’t always go as planned; there may be unexpected problems, delays, and disagreements. […]