November Research Group Announces the Availability of PRIMO Mail

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Ensuring effective and efficient source document intake with a fully 21 CFR Part 11 compliant email.

PRIMO Mail was developed with compliance in mind", explained Brad Gallien, President and COO of November Research Group

November Research Group, LLC, a global leader in the delivery of product vigilance software to leading biopharmaceutical and medical device manufacturers and regulators, is proud to announce the worldwide release of PRIMO Mail. PRIMO Mail is a fully 21 CFR Part 11-compliant email client designed to provide product vigilance departments with the flexibility and ease of use of a standard email client, with the added assurance that every action taken on an inbound document is fully audited and controlled; thereby eliminating the compliance risk of lost emails.

“PRIMO Mail was developed with compliance in mind. The objective was to keep the usability of email intake while eliminating the compliance risks associated with lost emails and lack of traceability of email handling processes during the intake process,” explained Brad Gallien, Vice President of Product Development and COO for November Research Group. Auditability and traceability of all source documentation is paramount for all product vigilance organizations.

PRIMO Mail works on any computer and all standard web browsers. The intuitive user interface allows team members to access inbound emails, prioritize and assign them as appropriate, and perform all standard email functions; Read, Reply, and Forward. Read messages can be archived into a fully configurable folder structure for reference. The key is that all of these actions are fully audited. In place of message deletion,

PRIMO Mail includes the ability to “reject” an inbound message. Message rejection is also fully audited and includes the capture of rejection reason in the audit trail. An optional add-on module allows customers to perform duplicate searching and attach emails and their contents directly to Oracle Argus cases.

PRIMO Mail is fully scalable built to meet the needs of global biopharmaceutical companies, multi-national CROs, and small biotechnology companies. Deployment can be on premise or in the cloud. November Research Group will be hosting a series of webinars in early 2017 to introduce the product to the market place.

About November Research Group
November Research Group is a Berkeley, CA based software development company, dedicated to delivering product vigilance solutions for the risk management era. The core team of software developers and quality assurance engineers have been developing software in this domain for over 20 years. The PRIMO product vigilance platform addresses the daunting regulatory challenges facing life science groups, by providing a Part 11 compliant solution for inbound email processing, streamlines case intake and triage, and deploys mobile and portal AE/PC intake. PRIMO manages global partner and regulatory submission commitments, and provides medical user access to pharmacovigilance data using powerful queries, all while leveraging an open architecture that embraces integration with emerging cognitive computing technologies.

For more information on upcoming Webinars and the full range of regulatory challenges that are addressed by the PRIMO product family, contact:

John Cheevers, Director of Sales, November Research Group LLC

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