Collaboration is More Than Just a Buzzword in Regulated Environments

Each year, there seems to be a buzzword that pervades the business community. This year, I recall hearing the word “collaboration” more than ever. For most organizations, the word is synonymous with “participate.”

Indeed Merriam Webster offers this definition: “to work jointly with others or together especially in an intellectual endeavor.”

In regulated environments, compliance affects an entire organization, making collaboration critical (1). The approval of a new drug or medical device, for example, requires concerted effort by all departments involved in a product lifecycle.  

For regulated companies, collaboration refers to a process that encompasses a lot of things. It could mean a quick document approval, or providing vital input on a document’s content, or a simple “thumbs up” or “thumbs down.”

Providing an ample opportunity for teams to collaborate can make a great deal of difference in the process. When the right people are offered an opportunity to share their ideas, redline a document, and provide comments, the impact can be substantial.

Manual vs. Electronic

How does your organization collaborate? Do you gather all key personalities in one room and work till you drop? Do you work on a paper document that you physically pass around? Do you route this document via e-mail?

All of those things fall under the “manual collaboration” category. More and more companies, especially in regulated environments, have replaced manual collaboration with the automated variety (2). They are increasingly using electronic systems and the virtual workspace to work together. Offer your teams the opportunity to collaborate electronically and major (often very positive) changes can begin to surface.

Here are some of the advantages of using an electronic system:

Automatic Routing: Team members no longer have to wait for the paper routing of a document stashed inside a folder with Post-it notes and totally illegible handwriting throughout. An electronic system will automatically route the document to every person you choose to include in your collaboration. Automation will dramatically cut your document approval cycle times.

Increased Efficiency: You will increase your efficiency with the simple fact that “collaborators” will be able to view all redlines clearly and add their input at their convenience without having to wait for the paper document to reach their desks. If you use a web-based electronic system, you can collaborate in a real time environment, allowing access 24 hours a day from virtually anywhere.

No Gaps: You don’t have to worry about the endlessly frustrating email chain (someone forgot to attach the file, or the wrong version was attached, etc.). If someone in your collaboration group is holding up the process, the system will automatically notify that person.

Enhanced Communication: An electronic system greatly improves communication and strengthens collaboration. One of my clients from the pharmaceutical industry once said, “When you get a collaboration task email notification from MasterControl, nothing stops you from getting out of your chair, pushing away from the desk, or even picking up the phone to communicate your thoughts with others. In fact, we encourage you to do just that."

In the end, this is perhaps one of the biggest benefits of using an electronic system—it encourages your team members to talk, redline, and bounce their ideas by making it easier and faster for them to work together. Collaboration, communication, conversation—all of these C words lead to an A+ in creating quality documentation.

Marty Jackson, a professional services consultant for MasterControl, is originally from Ann Arbor, Michigan, area. He’s a former Deloitte consultant with over 10 years of experience providing consulting services to businesses and government agencies, including 19 of Fortune’s Top 500 companies.


(1)  Collaboration between a CRO and sponsor is particularly critical. From “From Outsourcing to Offshoring into Emerging Markets: A Sponsor-CRO Relationship in Pharmaceutical Drug Development,” by Kuntal K. Sinha, Pharmaceutical Outsourcing. Viewed on Feb. 4, 2014, at:

(2)  For more information about automating the collaboration process, go to:

Note: The views expressed in this article are those of the author and do not necessarily represent those of his or her employer, GxP Lifeline, its editor or MasterControl Inc.


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