Experts from IBM and Axendia shared the Journey to CSA in “Welcome to Wednesday” Maximo Event. FDA’s Computer Software Assurance (CSA) draft guidance is intended …
Journey from Computer Software Validation (CSV) to Computer Software Assurance (CSA) Read More »
Propel Briefing Note Axendia was recently briefed by Chuck Serrin, VP Industry Marketing, Medical Devices & Life Sciences and Dario Ambrosini, Chief Marketing Officer, at …
Experts from AstraZeneca, Axendia and Tulip Interfaces shared how to move beyond a traditional validation approach and its reliance on non-value-added documentation to unblock your …
2023 Veeva R&D and Quality Summit Event Brief Axendia covered the 2023 Veeva R&D and Quality Summit in Boston on Sept. 13 and 14. The …
Veeva Extends Life Science Industry Cloud into Manufacturing Read More »
AspenTech Inmation Briefing Note Axendia was recently briefed by the Pharmaceutical and DataWorks Business Units at Aspen Technology, Inc., (AspenTech) on the acquisition of Inmation™, …
The FDA has taken another step towards realizing their vision for encouraging pharmaceutical quality management practices. FDA’s Center for Drug Evaluation and Research (CDER) has developed …
FDA Encourages Industry to Achieve Quality Management Maturity (QMM) Read More »
QbDVision® Briefing Note Axendia was recently briefed by the executive team at QbDVision® on its unified digital Chemistry, Manufacturing and Controls (CMC) platform. “Our focus is on breaking …
Accelerating Time to Market with Digital Tech Transfer Read More »
This month we celebrate 18 years of Axendia’s contributions to the life sciences industry. Since our inception, Axendia has continuously demonstrated exceptional dedication and innovation …
Axendia’s Remarkable 18-Year Journey as Trusted Advisors to the Life Sciences Industry Read More »
A common misconception in the Medical Device industry is that FDA is impossible to interact with and that they have no interest in working with …
TAP to Break the Stigma of FDA’s Inaccessibility Read More »
Comments Due by October 30, 2023 On September 19, 2023 FDA released its IT Strategy for FY 2024 – 2027. In 2009, Axendia completed a …
FDA Announces IT Strategy for Fiscal Years 2024 to 2027 Read More »
42Q Briefing Note Axendia was recently briefed by the leadership team at 42Q, a product division of Sanmina Corporation. With over thirty years of experience, …
Simplifying the Digital Factory with Multi-Tenant Cloud MES Read More »
Dot Compliance Briefing Note Axendia was recently briefed by the executive team at Dot Compliance, on its newly released, ready-to-use AI-powered QMS. Headquartered in Phoenix, …
Say Hello to Dottie: Combining Quality, Compliance and Production Optimization with AI Read More »
