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May 10, 2021

Review and approve Part 11-compliant regulated documents with Egnyte for Life Sciences

Life sciences teams are more decentralized than ever, yet the need for speed persists. Even before the pandemic, the ability to bring together quality, clinical and regulatory personnel to hit project timelines is what separated successful projects from those that languished. The pandemic added another barrier to an already complex venture.

Egnyte is meeting this challenge head-on by expanding its remote collaboration features for life sciences customers with support for Part 11-compliant review and approval workflows that enable the management of regulated documents. Its GxP-compliant workflows streamline the review and approval process, removing bottlenecks for regulated business processes and providing a single, compliant environment for designated stakeholders to collaborate on and approve regulated documents. This new expansion makes it easy for anyone in an organisation to initiate and track the review and approval of controlled documents with Part 11-compliant e-signatures.

Unified platform

The Egnyte for Life Sciences platform can be used to manage and accelerate the review and approval process, for example when collaborating on protocols or developing standard operating procedures (SOPs).

An administrator can create a workflow to start the review and approval process. They can choose to add ‘to do’ tasks, one-step approval or a multi-step process. Each stage can be defined, with the assignees and due date being specified. When one stage is completed by its assignees, the next automatically begins. Approval can require the user to provide a digital signature and reason for approval, in order to comply with Part 11 standards.

The platform captures and stores all of the audit information associated with the process, including CFR-compliant cryptographic e-signatures. It is possible to download the approved document, and the platform will generate a pdf of the document, including a signature page which provides the signature of the approvers as well as the name, date and reason for approval. In the platform’s ‘reporting’ section, the administrator can access reports and run audits. Audits can capture specific workflow actions, users, folders, files and time periods. The report presents all actions performed by users and automatic system actions.

It is easy for the user to see workflows and their status and to access reports. The software is flexible enough to handle the most complex workflows. Its collaboration and automation features reduce the complexity of regulated business activities by streamlining the ability of teams to work together.

Collaboration, compliance and control

The platform offers a number of features which are central to optimising review and approval workflows. It is flexible and scalable, meaning that it is able to accommodate workflows, whether the process involves single or multi-step approval. It is 21 CFR Part-11 compliant, ensuring GxP compliance by incorporating electronic signatures, granular user access control, detailed audit trails and checksums for data integrity. The centralized dashboard also allows progress oversight and automated notifications remind assignees when a task needs to be completed.

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Egnyte for Life Sciences

Egnyte for Life Sciences is a unified platform for life sciences documents and data. It is used by over 500 life science organizations to collaborate with external partners, manage regulated documents according to GxP standards and adhere to security and privacy regulations like GDPR and CCPA.

Customers benefit from a centralized location for valuable information, aggregating study data from the ever-increasing number of data sources. Egnyte puts you in control of the compliance envelopes, retention policies, security posture, and access profiles for your data, facilitating collaboration without sacrificing security. Combined with a compliance layer that enables rapid validation, Egnyte for Life Sciences reduces the complexity of managing regulated data. From drug research to clinical trials to eTMF archiving, Egnyte for Life Sciences helps Quality, Clinical Development and IT teams take control of their most valuable asset, their data.

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