Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system (QMS) is effectively and clearly documenting procedures and work instructions that are easy to understand and execute. This article presents the requirements for documenting QMS procedures and work instructions, and then introduces methods to effectively and clearly do so.
This two-part article explores the use of various tools and the emergence of intelligent solutions in the industry.The first part provides an overview of how technological advancements and data analytics are critical in enabling regulators and the life sciences industry.
Who is ultimately responsible for quality/the quality management system at a life science company: (A) all personnel working for the company, (B) the quality assurance department, or (C) company management (including top executives)? Note your answer somewhere before reading this article.
Most manufacturing strategies today include some level of support from an outsourcing service provider such as a CMO or contract testing lab. There has been a great deal of discussion regarding the elevated role these providers play in the drug development process. Today’s CMO is likely to not only execute critical development activities but also provide insight based upon their own experiences with multiple processes.
The FDA guidance Medical Device Accessories – Describing Accessories and Classification Pathways, clarifies much of the confusion regarding accessory classifications, making now a good time to conduct a gap analysis to identify a thorough list of your current and future accessories, and to determine the guidance’s applicability to each.
Recent revisions to the International Council for Harmonisation (ICH) Guideline for Good Clinical Practice, as outlined in ICH E6 (R2), have provided an impetus for sponsors to reevaluate their oversight and quality management processes throughout the clinical development process.
The EU’s General Data Protection Regulation (GDPR) will go into full effect on May 25, 2018 — as will penalties for non-compliance. While most of the GDPR affects the back end of medical device data handling, the Cloud, Databases, and transportation of data, some of the GDPR affects software on medical devices themselves:
Quality risk management (QRM) is not a concept to be applied in a vacuum. Rather, it is a discipline that provides the most value when used throughout the product life cycle.
An adaptive design is a design that allows for modifications to the processes and statistical procedures of a clinical trial, usually at set intervals established in the trial protocol. Adaptive designs are useful for increasing efficiency and lowering costs associated with clinical research. Studies incorporating adaptive design techniques can be useful in redirecting subject allocation to concentrate on the most promising treatments or in stopping a trial early for futility. The temporal and monetary savings resulting from adaptive designs make them of great value in drug and medical device development.
Real-world evidence (RWE) has become increasingly important for innovative manufacturers looking to convince reluctant payers that their new medicine has a place in patient care. Indeed, many claim the changing nature of the data landscape in healthcare will revolutionize the way we consider evidence, but does this apply to biosimilars? Is there a real need to look at data from actual clinical practice before or after market entry for these products?