Life Science Document Management FAQs
The following Q&A covers common questions user ask about GlobalSubmit’s COLLABORATE document management system for life sciences.
1. Is the system locally installed on our servers and network?
COLLABORATE is a cloud-based system configured for the needs of companies in Life Sciences on a SharePoint foundation. Our unique DMS for Life Sciences does not require you to have a supporting infrastructure beyond secure internet connection. Because GlobalSubmit’s document management system COLLABORATE is cloud-based, we manage and maintain the hardware, farm, software, complex security, backup, failover configuration, load balancing for highest industry quality expectations and effective disaster recover planning and actions for minimized downtime.
2. If I have SharePoint, can I install COLLABORATE on my servers?
To maintain the highest level of customer service and satisfaction, COLLABORATE is not offered as a local install for customers currently using SharePoint.
3. Can our outside contracted suppliers access COLLABORATE easily?
Yes. As our COLLABORATE DMS software is accessible in the Secure CLOUD built on Amazon Web Services (AWS) configuration, your team, regardless of location will have access to the system as needed. Through SharePoint’s user and group permission configuration you have the ability to promote or demote individuals and groups global access on the fly.
4. How secure is COLLABORATE?
Very. In fact, GlobalSubmit COLLABORATE is arguably on the most secure cloud computing system available. Using Amazon Web Service (AWS) as our provide, we share the same essential infrastructure and oversight as the US Department of Defense, CIA and 298 other Federal Agencies that seek the highest level of security and scalability as defined by FEDRAMP. Beyond the integrity of AWS and SharePoint’s own permissions controls, GlobalSubmit’s cloud-based security server has additional levels of access and monitoring in place to keep your Intellectual Property secured.
5. Is COLLABORATE optimized for our regulatory needs?
Yes. COLLABORATE was designed specifically for the needs of our Life Sciences customers to easily author, share and optimize their growing portfolio of documents for the purposes of streamlining agency submission. Metadata driven and optimized for Microsoft Office business applications, the system comes with the full regulatory eCTD structure as required in the ICH headings and hierarchy.
6. Does COLLABORATE meet 21 CFR Part 11 compliance standards?
Oh, yeah. This is the first requirement we had to meet. We recognized early on that your medical writers and regulatory professional demand a system that is not only compliant with the FDA’s 21 CFR, Part 11 but that the system adheres to those compliance standards without the burdening the user. Compliance with COLLABORATE is automated. Just by managing your documents within the four walls of COLLABORATE compliance is maintained at the highest level.
7. How can I add documents to the correct CTD section and find them later on?
Beyond a simple drag and drop, as part of the system implementation GlobalSubmit eCTD templates come (optional) preloaded in the germane CTD sections for fast authoring directly in the targeted sections. Clients also have the option of embedding their own templates. Additionally through crumb-based click, recent document screens and a text/metadata based search box it is useful resource for locating and opening recent documents.
8. Is COLLABORATE optimized from metadata?
COLLABORATE is quite possible the system best configured for industry harmonization and regulatory submission software integration. As part of our product roadmap COLLABORATE will provide a uniform user experience from document management through to publishing and agency RIMS communication. COLLABORATE is a metadata driven system providing an ease of field and keyword mapping for a variety of future client needs.
9. Do you have workflow integrated into the system?
The design of GlobalSubmit COLLABORATE includes an intuitive workflow system that is not only extremely easy to start and stop, but integrates automated notifications to role-based users or groups for an uncluttered experience. COLLABORATE comes with 3 standard Life Science workflows that are configured out of the box.
10. How simple is COLLABORATE to operate?
Very, very simple. Applying the principles of user-centric design, and taking a page from some of today’s best interface designs that have changed the consumer experience for online shopping, information searches and mobile phone use, COLLABORATE looks to modernize and redefine document management for Life Sciences. We reached out to industry to find out what you wanted more or, and less of. Industry input resulted in a user experience that simplifies a complex industry. We seek to have our users saying, “I enjoy working in GlobalSubmit COLLABORATE.”
11. Can my group work on documents at the same time?
Group collaboration is serial for version 1.0 in order to omit broken audit trails, and maintain the highest level of compliance. We have begun plans for integrating group collaboration functionality into the system while preserving the requirement of 21 CFR Part 11 compliance.