fbpx
 
 
Schedule a Demo
HomeSearch

WA 0

Pharma

ICH Expands on Analytical Methods Validation in Draft – Q2 Update

September 22, 2022
The FDA has released a second guidance from the International Council for Harmonization (ICH) related to analytical methods used in drug products, which is open for comment through Sept. 28, 2022. This latest version of the ICH Q2 series of guidances offers substantially greater detail than the previous version, suggesting that managers of drug manufacturing facilities should begin examining this policy on analytical methods validation to ensure the facility is prepared for the final version.
Medical Devices

FDA Releases ICH Draft Guidance for Drug Analytical Procedure Development

September 13, 2022
The FDA has posted a draft guidance for pharmaceutical analytical procedure development by the International Council for Harmonisation (ICH), which is accompanied by a draft guidance for validation of those analytical procedures. This Q14 analytical procedure development draft takes up the question of how analytical technologies can be managed as part of the production process lifecycle change management, and thus the overarching intent is to provide a set of principles that help to ensure that drug product quality remains high in a cost-effective manner.
Medical Devices

FDA’s Cybersecurity Premarket Draft a Significant Rewrite

April 12, 2022
The FDA has reissued draft guidance for premarket cybersecurity considerations four years after the previous draft guidance, and eight years after the issuance of the most recent final guidance. While this draft guidance is not the final word on this policy, we would advise our clients that it represents a fundamental shift in the agency’s approach to cybersecurity, one that comes with a substantially more demanding set of requirements in the premarket phase of device development.
Digital Health

Digital Tech for Clinical Trials May Carry Hefty Compliance Requirements

January 1, 2022
The FDA’s new draft guidance for the use of digital health technologies (DHTs) for remote data acquisition in clinical trials promises to help advance the market for a wide range of products in the digital health space. However, developers of these products should be aware that their products will be subject to a substantial amount of verification and validation work, along with a considerable load of usability studies.

CAPA

September 1, 2020

Newer Posts

Older Posts

Enzyme's eQMS transformed our quality management process. The user-friendly system and rapid document loading made the switch from paper seamless. Their support team's expertise ensured a smooth migration of our historical documents and is always available to answer questions. With Enzyme's eQMS, we're confident our quality system is well-organized and audit-ready.
Juan Hinojosa, Quality EngineerClearCam
Comparing how we did QMS at GeneWEAVE without Enzyme and how we do things now is night and day.
Diego Rey, Chief Scientific OfficerEndpoint Health
The team at Enzyme has helped us streamline our quality process and post-market compliance, including our QMS process. Their level of professionalism and service has been outstanding.
Enhao Gong, CEOSubtle Medical
The care and thought the Enzyme team has put into designing and implementing the eQMS has made our lives one thousand times easier.
Judy Brimacombe, VP Clinical, QA, RADawnLight Technologies

Electronic Quality Management System

Enzyme eQMS is flexible and scalable, making it easy to use for startups, yet configurable to meet the needs of the most complex enterprise

Connect with us

Product

Company

Product

Company

Newsletter