Gemstone takes collaborative authoring and document management to a whole new level.

As a research and development organization, wouldn’t it be great to do everything you you need with documents in one place? Imagine one easily accessible and secure place for the team to create, share, edit, store, and archive documentation? Gemstone is an on-line document management and collaborative authoring system designed specifically for life sciences organizations to help you get further faster.

Gemstone is available in four license types, each with varying capabilities, to enable companies to select and customize the exact capabilities needed for their organization:

  • Gemstone – create, share, preview, collaborate, edit, store, and archive documents in a system that is fully compliant with US and EU document management requirements.
  • Gemstone EDMS – create, share, preview, edit, store, and archive documents.
  • Gemstone Consumer – share documents for viewing, but not editing, printing, or downloading
  • Gemstone Submissions – plan, organize, and stage regulatory submissions

A detailed description of each license type and the associated functionality is provided below.

Importantly, because R&D is fast-paced and ever changing, license types can be modified “on the fly” as business needs dictate.

Gemstone

Gemstone full access includes the ability to add, modify, or preview documents in Gemstone, as well as the ability to initiate or join an on-line collaboration session to modify or comment on a document currently stored in Gemstone. Whether you are in the same room or across the world, share and collaborate on documents like you’re right there.

In Gemstone, you can create, share, preview, edit, store, and archive documents in a system that is fully compliant with US and EU document management requirements.  You can also open documents for on-line collaboration to modify or comment on the contents of a document stored in the system.

Whether your team is working in the same building or are scattered across the globe, Gemstone makes it easy to collate and resolve team comments quickly so you can finalize documents faster.

Simple

Collaboration helps speed your documents to finalization. You and your team can make comments and track edits dynamically in Word documents in Gemstone using Office 365.

Secure

Email notifications are sent to team members invited to collaborate and a convenient link is provided directly to the collaboration document in the system.

Compliant

Collaboration is built on top of a secure, compliant document management system.  All the benefits of Gemstone EDMS are built into Gemstone.

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Gemstone EDMS

Gemstone EDMS provides the ability to upload, download for editing, and preview documents in Gemstone, but does not allow for on-line collaborative authoring or on-line commenting.  Share documents and updates with colleagues next door and across the world quickly and easily using Gemstone’s cloud-based storage.

For teams that do not want to collaboratively author documents, Gemstone EDMS allows you to create, share, preview, edit, store, and archive your documents. Gemstone’s cloud-based storage system is fully compliant with US and EU document management requirements and comes with a simple and intuitive organizational (folder) structure that is used throughout the pharmaceutical industry.

Intuitive

Gemstone EDMS is a secure document management system that is compliant with US and EU document management requirements.


Each person on your team will have a separate Gemstone EDMS user name and password which will allow you to store and share documents with your team securely.


A simple and intuitive folder structure makes it easy to find your documents.

Customized

Built-in version control ensures you always have the latest document draft.


Customized folder structures and naming conventions can be created for your special needs.


Permissions are granted for each user and can be set on a system, folder, or file level, allowing you ultimate control to documents in your system.

Powerful

A powerful search engine makes it easy to find documents in the system.


Regulatory documents, project management information (e.g., GANTT charts, power point presentations, excel spreadsheets), and business information (e.g., SOPs, contracts, personnel files) can all be stored securely in the system.


Great for teams who need a document management system, but who do not want to collaboratively author.

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Gemstone Consumer

Gemstone Consumer provides on-line read only access to documents.  Documents cannot be printed, downloaded or modified.  This is a great option for distributing read-only documents to sites or enabling secure access to documents during Due Diligence.

Due diligence is an important business activity for many R&D organizations.  Gemstone Consumer enables easy, secure, and short-term read-only access to selected documents already in your system.  With Gemstone Consumer, documents can be viewed, but cannot be printed, downloaded or modified.

Gemstone Consumer is also a great option for organizations who want to distribute read-only documents to sites or key opinion leaders.

Accessible

Gemstone Consumer is ideal for due diligence activities. You no longer need to set up special servers, systems, or folders.  You simply decide who should have access to what content in your existing Gemstone system.  Using permissions in Gemstone EDMS, read only access is granted to a file, folder, or all of your documents.

Easy

Gemstone Consumer users can only view content. They cannot modify it, download it, or print it.


The audit trail function in Gemstone EDMS logs every action taken on a document in the system, including opening it for viewing.

Short Term

Gemstone Consumer is also used to share documents with investigator sites and interested parties who want to review content to be included in regulatory submissions (e.g., corporate executives, business development, advertising and promotions, contract manufacturers, etc.).

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Gemstone Submissions

Gemstone submissions provides the ability to plan and organize submissions using documents stored in the Gemstone EDMS.  Gemstone organized submissions can be exported to any publishing system for creation of an electronic submission.

Confidence

This capability in Gemstone is ideal for the regulatory affairs expert who wants to build and stage regulatory submissions.


A submission structure can be built prior to any documents being written. This enables the regulatory lead to drive the team to create the right documents for the eventual submission.

Speed

The submission structure can also include documents that are being drafted. Once the documents are final, a simple right click allows the regulatory expert to select the right version to include in a submission.


Gemstone Submission eliminates tedious creation and modification of tracking forms (usually excel spreadsheets) to instruct publishers of the file names, file sizes, and CTD locations of content to be included a regulatory submission.

Control

Gemstone Submission allows for “iterative” builds – sending documents to publishing before the entire submission is completed. Iterative builds enable publishers to create sections of a submission that can be reviewed while other content is being finalized.  It is particularly helpful for large submissions (e.g., INDs/CTAs, NDA/BLA/MAA, 510Ks, PMAs, etc.).


Gemstone Submission allows you to identify where a document is used in a regulatory submission or submissions. A link is provided to the original source content in Gemstone EDMS for ease of viewing or modification, as desired.

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