ABOUT EGNYTE

Egnyte for Life Sciences is a unified data collaboration platform to serve those advancing the science of health. The advanced platform supports features designed to maintain regulatory compliance, support secure sharing, and manage data governance. More than 16,000 businesses, and more than 400 life science organizations, trust Egnyte to provide visibility and control into their most valuable asset, their data. For more information, visit www.egnyte.com/lifesciences

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FEATURED PRODUCTS

Make remote work easier with secure file access, sharing and collaboration.

Accelerated GxP and 21 CFR Part 11 compliance without disrupting your existing workflows.

Automate and manage privacy & compliance programs.

Lock down file access with a least-privilege, granular permissioning model to reduce the risk of attack - even in mobile and highly distributed organizations.

Locate sensitive information and unusual behaviors, encrypt files, and prevent data theft.

Intelligently manage the entire file lifecycle, from creation and active usage to archival and removal.

Locate and classify files quickly and automate reporting.

Compliance, Collaboration, Control: Streamlining the Development Process.

CONTACT INFORMATION

Egnyte

1350 W Middlefield Road

Mountain View CA 9404, CA 94043

UNITED STATES

Phone: 877-734-6983

Contact: James McManis

FEATURED ARTICLES

  • There is always a balance between speed and compliance, while others struggle to adopt new technologies because of the uncertainty of how to comply with FDA regulations. Needless to say, developing a quality and compliance posture that meets the needs of both masters (business stakeholders and auditors) is a tall order. In this piece, we will chronicle the trends that successful quality & compliance teams adopt to keep pace with the speed of discovery.

  • Like many in the Life Sciences, the challenges that Fulcrum face are similar to those across the drug-development industry. The outsourcing of specialized tasks is increasing, and the data that is generated from these efforts is massive, often unstructured, and scattered across repositories. Maintaining GxP compliance, creating a secure environment for collaboration, and ensuring there is a single source of truth are becoming more and more of a hassle. Read how Fulcrum has turned to technology to help automate many of these processes in order to streamline collaboration with third-parties and the organization of data into a single repository.

  • The GDPR is a significant advancement of consumer data protection rights. The European member states agreed to a set of principles that would penalize organizations that don’t safeguard personal identifying information (PII). If your team or clinical trial operates in the EU, California, S Korea, Australia, or a dozen other countries, your data could be subject to strict privacy laws. Violating GDPR, PIPA, APP, or CCPA, among others, have serious consequences for your program. Learn how to mitigate risk and keep on the right side of regulators.

  • Drug development has dramatically changed over the past ten years. A practice once dominated by pen-and-paper has since been overrun by computerized systems, cloud software, and artificial intelligence. In this piece, we will chronicle recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.

  • As life sciences companies grow, the regulatory compliance requirements, and risks, expands as well. These responsibilities extend beyond conventional health-related frameworks (e.g. GxP, HIPAA, etc.) but into the realm of data privacy as well. For high-growth institutions with limited resources & bandwidth, the question arises: what should you do?

  • Over the past 20 years, the life sciences industry has undergone massive changes, and new software and partners have emerged. There are three key ways that business can serve the dynamic needs of modern drug development.

  • A critical output of the drug development process, besides the compound itself, is data. We highlight specific actions to mitigate your organization’s risk of data manipulation and three key steps in tackling this problem.

  • Given the complexities that arise when securing data in drug development and developing software that facilitates common workflows, ensuring best-of-breed security simultaneously is the key to success.

  • Prompted by COVID, many businesses have already started experimenting with or adopting modern business-class, cloud-based file sharing. Here are the benefits and areas where companies can slash the cost and complexity of file sharing.

  • Remote work increases the level of difficulty of proper data governance and security to prevent attacks like hacks, ransomware, and data carelessness. Read how to mitigate the risks associated with the human side of data governance and information security.

  • Are you finding it increasingly challenging to manage your organization’s regulatory submission process? The entire process of developing a drug from preclinical research to marketing takes approximately 12 to 18 years and can cost billions of dollars before a drug is even approved. Learn how the advantages of a good ‘compliance envelope’ can far outweigh its costs by making companies operationally more effective, with a positive impact on the top line.

  • Keeping the clinical trial data secure and compliant is paramount. Restricting access to only those that need it is an essential first step, but there is much more that needs to be done. To help you in your journey, we’ve created a list of five common ways that trial data puts us in jeopardy, and approaches you can take to avoid these risks.

  • Checklists work for things like house maintenance; you identify and fix the things that don’t meet building codes, and then you feel safe, and the building inspector is happy. Content, however, doesn’t operate like that. Some content is essentially stateless; because of collaboration or continuously changing data, content assets change. Identifying adherence to compliance controls, therefore, means it has to be evaluated continuously. Automated, continuous monitoring is imperative for companies that depend on their critical content to make business decisions and conduct operations.

  • Assessing data quality is not always simple. There are numerous variables to consider. To make it easier to fine-tune these considerations for all business requirements, we've broken them down for you.

  • The safety of business content is a top priority for every company. Especially at a time when data breaches and other cyberattacks threaten the stability of our systems, protecting our data is an essential corporate function. Learn how to make security improvements to minimize the risk of internal and external threats to content by weaving content intelligence and data governance into every layer of the file sharing and collaboration architecture.

  • Drug development has dramatically changed over the past ten years. A practice once dominated by pen-and-paper has since transitioned to computerized systems, cloud software, and artificial intelligence. This paper chronicles recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.

  • In GxP environments validating and documenting mission-critical systems are required to ensure the integrity of data and audit-readiness. Yet, given the number of systems used, it is unclear which electronic systems require validation and which do not. This checklist provides a framework for evaluating which software should/not be validated.

  • Travere Therapeutics is a San Diego, CA-based biopharmaceutical company that develops life-changing therapies for people living with rare diseases. When it transitioned to a primarily remote workforce in 2015, it needed to keep its work moving forward at the same speed. Accessing the cloud-share via VPN from one end of the country to another wasn’t just painfully slow, their people were losing connection, too. They needed a solution that would help keep drug development on track regardless of the location of each team.

VIDEOS AND WEBINARS

  • Transitioning from the research phase to the clinical trial phase is a big step for any company, but it also means challenges, not the least of which means your electronic records need to comply with FDA 21 CFR Part 11 and GxP. In this democast, we will review how to deploy and use a GxP-compliant repository using Egnyte’s industry-focused platform, Egnyte for Life Sciences, without sacrificing usability or security, and without creating administrative overhead.

  • There are many steps that need to be performed in order to assemble an Investigational New Drug (IND) Application. Whether it be consulting with the FDA, using a GxP compliant collaboration platform, or finding a partner, this process is often complex. Despite the numerous steps, it does not have to be an insurmountable goal. This webinar reviews 5 key best practices for assembling your IND and identifies specific tips that you can integrate into your workflow today.

  • Many companies struggle with ensuring a strong compliance envelope as they transition from an R&D culture to a more-structured, regulated one. In this video we will cover Egnyte for Life Sciences platform overview focusing on audit trails, versioning, and reporting capabilities that can help you overcome your compliance challenges.

  • In this webinar we are joined by Rahul Chaturvedi, an expert in clinical development with 10+ years of experience, who discusses some of the ways clinical trials are being disrupted and how to shift your mindset to take advantage of this time to strengthen your clinical program.

  • Clinical trials are evolving. Whether it’s disruptive technology, changing regulations, or external factors. The pace of change is only increasing - along with the complexity of ensuring your trial data is secure and compliant. This session will provide best practices and insight into how to keep pace with the changes and be better prepared for what’s still to come.