Regulatory bodies like the FDA enact initiatives on a routine basis. While their timing may seem random, such actions are usually driven by logic; most are taken in response to some noteworthy concern.
We know that COVID pushed the digital transformation and the cloud solutions, in combination with the broad access of the Internet, turning data consumption economically capable and available, creating an exceptional volume of data nowadays.
The Quality Systems (QS) Regulations of FDA 21 CFR 820 are general standards that apply to finished devices, that are intended for human use. Rather than impose strict requirements, the regulations offer an opportunity to the manufacturers of these devices to incorporate their quality management standards into key organizational processes.
Let’s start this piece with a question for ourselves: do we still need password expiration as a security measure? In today’s life science industry, especially the pharmaceutical sector, a number of compliance reasons, guidelines, and agency regulations are responsible for an organization’s requirement to have their employees change their passwords every so often. It is now fair to say that we arrived at a point in time where most of the reasons behind the password expiration policy seem obsolete.
According to a report from the US Food and Drug Administration (FDA), major deficiency letters were issued to 67% of premarket approval applications. Such deficiencies in applications can hold up premarket approvals - sometimes more than 180 days.
You have received one of the dreaded FDA Warning Letters. The last thing you want is to delay the launch of your company's latest innovation. However, you cannot risk shutdown for non-compliance and the possibility of never making it to market with your latest brainchild.
The ICH E6 Good Clinical Practice Guideline is a cornerstone in today’s guidance for Good Clinical Practice (GCP). The guidance addresses an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. With the goal to provide a unified standard for all ICH regions to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. As of March 2021, the newest revision R3 is in a draft state, so we took the opportunity to run down the important aspects of Data Integrity and Data Governance inside the first iteration of the ICH E6 GCP principles.
Our last Webinar about data integrity was a great success, and we thank you all for the questions and participation. We believe we can bring value to the industry when we collaborate to give insights and share solutions to our customers' challenges within compliance in Life Science.
The CAPA process from the side of regulatory compliance of both U.S. FDA requirements (21 CFR 820.100) and EU regulatory requirements (ISO 13485, 8.5.2) is one of the most important elements of a Quality Management System (QMS).
It is essential to develop a system the right way to assure QMS effectiveness and minimize irregular findings on regulatory audits.
Blockchain is the technology that created the 128 Bi cryptocurrency market, which is at the heart of Bitcoin and other virtual currencies such as Ethereum, Tether, and more. The Blockchain is an open, distributed ledger that can record transactions between two or more entities in an efficient, verifiable, and permanent way. The ledger itself can also be programmed to trigger transactions automatically (smart contracts).
