Life Sciences: Improving time to market through effective documentation governance
By John Hanrahan | January 16, 2015
For Life Sciences organizations, time to market is critical
One of the key challenges for improving product time to market is the sheer volume of documentation that must be maintained in a manner that’s compliant with regulatory standards.
Documents exist at all stages of the product lifecycle: from R&D, to eTMF documents for clinical trials, batch records for manufacturing, to commercialization documents. And content comes from all kinds of unrelated sources – from a variety of software file types, hard copy documents, and even emails and their attachments. Regardless of the source, content must be consolidated and managed. It must be properly archived, but still easily accessible. And it must be rendered into a PDF format that allows for easy distribution, fast and easy updates when source documents are modified or added, while still maintaining security and compliance.
No doubt you’re thinking “But we already have a PDF solution.”
You might even have Adlib PDF installed and quietly going about its business in the background. However, the latest version of Adlib PDF Enterprise, along with our collaboration with Generis and Court Square Group now bring you capabilities to inject even more efficiencies into your document management process, from start to finish.
Adlib PDF Enterprise is for more than just submissions
Did you know Adlib PDF Enterprise gives you significant capabilities for document publishing throughout your clinical trial phases? With Court Square and Generis consolidating eTMF documentation, Adlib PDF Enterprise and its Advanced Rendering capabilities allow you to render your clinical trial documents into a single, manageable PDF document with cover page, table of contents, bookmarks, working (or disabled) hyperlinks, valid watermarks and more. As a single, secure document, it can be quickly distributed to Clinical Research Organizations and the individuals performing the trials. It can be easily updated when documents are modified. And it’s text-searchable which can save hours when looking for specific information within documents that could be hundreds or thousands of pages long! All while improving efficiency, reducing manual effort, eliminating errors and inconsistencies, and maintaining compliance.
Adlib PDF Enterprise also gives you these same capabilities throughout your product lifecycle. Batch records for manufacturing can consist of literally hundreds of pages, as can commercialization documentation. But with Adlib PDF Enterprise, working in conjunction with content management systems from companies such as Generis and Court Square, you have the ability to consolidate critical documentation into a single-source document that can be updated quickly and easily, while remaining compliant.
Want to know more? Join us for our upcoming event:
The 3Cs: Collaboration. Compliance. Centralization.
Chicago, February 4, 2015
Boston, February 5, 2015
Join Adlib, together with our partners Generis and Court Square Group, for this open panel discussion event, where you will learn:
- How streamlined collaboration with internal and external stakeholders through all product lifecycle stages can improve processes and reduce timeframes. Plus, how creative technology collaborations – such as Adlib + Generis + Court Square Group- allow you to leverage existing technology investments, plus optimize business processes for accelerated time to market.
- How centralized content management facilitates compliant, submission-ready content plus reduces risk of human error in manual processes.
- How automating compliance processes creates more efficiencies throughout the enterprise, resulting in better cost control, more effective document management, and reduced time to submission.
Our Guest Speakers
Chicago: Antoinette Azevedo, Co-Founder, RegDocs365 LLC
Annette Azevedo is a longstanding, industry-recognized subject matter expert in regulatory submissions to the FDA and international regulatory agencies. In 1995 when she led the first team to implement an all-electronic authoring, document management, and publishing solution whose proof of concept was an MAA submitted to the French health authority in 1996. She co-founded RegDocs365 in 2013 in order to bring cloud-based solutions to small and virtual biotechs for content management and submission publishing.
Chicago and Boston: James Kelleher, CEO, Generis
James Kelleher has been actively involved in the technology industry specializing in Content Management for Life Sciences since 1990, spending several years with GlaxoWellcome (now GlaxoSmithKline / GSK), before founding Generis in 1997. Generis has since grown into a specialized software provider of solutions for regulated documentation, and counts many Fortune 100 companies among its clients. James was recently invited to join the DIA GxP Quality System Reference Model Work Group - the group is tasked with developing the Reference Model for GxP documentation.
Boston: Keith Parent, CEO, Court Square Group
Since founding Court Square Group in 1995, Mr. Parent has been involved in the implementation and maintenance of enterprise level systems across the pre-clinical and clinical organizations of numerous Life Science clients. Mr. Parent oversees numerous FDA and HIPAA regulated environments as well as being the exclusive North American Hosting partner for a Healthcare focused Mobile computing solutions company. He currently serves on the board of directors for the Connecticut Biomedical Engineering Alliance and Consortium (BEACON) and AIM (Associated Industries of Massachusetts).
Please register to learn more about how Adlib, Generis and Court Square Group can help you make compliance and submissions processes faster and more efficient.
P.S. Don’t have time to attend? Reach out to us for more information on how together with our growing partner ecosystem, we can impact critical business processes.
About the Author