Global regulations regarding software validation (e.g., 21 CFR Part 11, Annex 11, etc.) have been in place for many years. With an increasing number of software-as-a-service vendors offering GxP-compliant solutions, it is more important than ever that CSV and QA teams of all sizes make use of sensible approaches to software validation to better manage their overhead while maintaining compliance with regulatory requirements.
Time flies when you’re building an industry-leading platform for secure content collaboration spread worldwide! July officially marks fifteen years since we filed our articles of incorporation in 2008. The co-founders of Egnyte (Vineet Jain, Rajesh Ram, Amrit Jassal, and Kris Lahiri) were actively involved in the festivities and helped to make this milestone even more memorable for employees across the globe.
For nearly a decade, Egnyte has been applying AI to help customers protect and manage large volumes of unstructured data. The outputs of these models were historically focused on a relatively narrow set of IT security, privacy, and compliance applications. Today, we’re announcing the next generation of AI-powered solutions at Egnyte, unleashing content intelligence for every user on our platform!
In the 1960s, Theodore Levitt published his now famous treatise in the Harvard Business Review in which he warned CEOs of being “product oriented instead of customer oriented.” Among the many examples cited was the buggy whip industry. As Levitt wrote, “had the industry defined itself as being in the transportation business rather than in the buggy whip business, it might have survived. It would have done what survival always entails — that is, change.”
Effective Trial Master File (TMF) management is crucial for regulatory compliance in clinical trials. An audit can happen at any time, so sponsors and CROs must ensure that all required documents are accurate and accounted for throughout the lifecycle of a study. Ongoing inspection readiness is easier said than done, which is why many organizations leverage an eTMF solution to help. But there are a lot of eTMFs out there, and evaluating your options can be overwhelming.
This month's release rollup includes file and folder shortcuts, updates to the PDF viewer, and redesigns to the configuration settings for WebUI. Below is an overview of these and other new releases, and visit the linked articles for more details.
Following the Grenfell Tower tragedy, the UK government commissioned Dame Judith Hackitt to conduct an independent review of building regulations and fire safety. In her report, "Building a Safer Future," Dame Judith proposed the use of a "Golden Thread" as a tool for managing buildings as holistic systems and enabling people to design, construct, and operate their buildings safely and efficiently.
Architects and engineers know that success depends on getting the right information to the right people at the right time. And when it comes to projects, having access to essential digital content from Newforma makes all the difference; but getting that content into a unified platform is critical.
As a CIO at a mid-sized company, I faced a new challenge when vendors asked for more specifics about our information security and the protocols we have in place to safeguard our sensitive data. Naturally, those questions were directed toward the IT team (and were phrased in ISO 27001 terminology), which was initially challenging because we had limited knowledge of that particular standard.
As part of our ongoing commitment to providing a seamless co-editing experience to Egnyte users, we have introduced new enhancements that enable Windows and Mac users to open any Microsoft Office-supported file such as Word, Excel, and PowerPoint, and start or join a co-editing session directly from the Microsoft Office App. Users can also co-edit in real time using the Egnyte Desktop, Online or Mobile versions.
