The 3 Biggest Project Management Problems in the Regulated Environment

Effective project management helps your company save time and money by keeping projects on time and on budget. It optimizes your resources by assigning the right people with the right skills for every project. In a regulated environment, you need all of these, plus one more crucial consideration: compliance.

Regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Health, Labour and Welfare (MHLW) in Japan expect companies under their jurisdictions to have a formal project management plan that addresses relevant requirements, design control, and change control, among other things. While these entities have different requirements, all of them emphasize risk management. Whether the project involves launching a new medical device or validating software for the purpose of FDA compliance, regulated companies are expected to incorporate risk management in projects that directly affect patients, such as clinical trials.

In the past decade, I've worked with about 200 highly regulated companies in addressing their compliance and business needs, especially in evaluating and choosing the right quality management system. In this article, I will talk about the three biggest problems in project management, based on what I've observed working with regulated companies.

3 Biggest Problems in Project Management

  1. Poor Documentation and Document Control

    In the eyes of regulators, a task is not complete unless it is documented properly, verified, and approved. Companies using paper-based or hybrid (part electronic and part paper) systems get bogged down in manual tracking via email and logging of status in disparate tools such as spreadsheets. When you add the burden of documentation to project tracking, it becomes a very onerous, labor-intensive project that is prone to errors and gaps.

    If project tasks are not documented properly, the repercussions are very costly. Considering the immense investment requirement for product design, clinical trials, and the like, the risk of not having proper documentation of all activities is significant.

    For example, the development of a new medical device takes anywhere from 18 months for a 510(k) product to five years for a device requiring a PMA, requiring millions of dollars in the process. Imagine if after all that time, effort, and cost, you find out that the requirements for design controls and design history file (DHF) or the technical file documentation have not been met. What ensues is a “treasure hunt” for documents that may not end in success if good processes and documentation were not used, which ultimately results in very costly delays in getting product to market.

  2. Project and Tasks are Not Connected

    Many organizations use tools like Microsoft Project to manage tasking and status. The challenge with these tools is that they are often completely disconnected from the end users completing the tasks and the all-important documentation that contains the results of said tasks. By integrating the tasking with the documentation and allowing the end users responsible for completing the tasks to sign-off on tasks and documentation, this gap can be filled.

    Let me use MasterControl Projects (1) as an example because I know it well. With this module, the project plan is connected to the tasks. So the system knows when a document is approved or when a task is completed. It automatically updates the plan. In the same vein, if there are incomplete tasks or languishing documents, the system tracks and escalates them automatically. If you're using Microsoft Project, you can import your templates into MasterControl, eliminating the need to create templates manually.

  3. Ineffective Project Management Structure

    While more and more companies are designating dedicated project managers to help ensure compliance, they are not as proactive in establishing an effective structure and choosing the right tools to manage their projects. Some small or medium-sized companies make do with a paper-based system for the time being. Over the long haul, those companies should leverage the latest technology that would take their project management to the next level.

    Going back to my example of DHF, a solution like MasterControl Projects can automate project management tasks common in the design control process. The system will manage all tasks, documents, schedules, and resources from start to finish. Every time a document is approved, a process is completed, or a milestone is achieved, the system will update the project plan without manual intervention. It will provide you with a best-practice workflow that incorporates all the steps in a typical development project and automates the creation and population of the DHF. Compare that with doing everything manually under a paper-based or a hybrid system.


Using an effective integrated project management tool not only reduces the risk of delayed product commercialization, but it can also act as a catalyst to standardize processes across the organization. Many companies are implementing “lean” principles and standardizing processes. A good project management tool will help facilitate these initiatives resulting in better quality, compliance, and efficiency.

Note: The views expressed in this article are those of the author and do not necessarily represent those of his employer, GxP Lifeline, its editor or MasterControl Inc. Paul Sanderson is the head of MasterControl's Solutions Consultants Group. He has spent the last decade helping almost 200 regulated companies choose the right eQMS based on their unique needs and implement it successfully. He has 10 years of enterprise software experience in the life science space.


(1) To learn more about MasterControl Projects, go to:


Paul Sanderson is the head of MasterControl’s Solutions Consultants Group. He has spent the last decade helping almost 200 regulated companies choose the right eQMS based on their unique needs and implement it successfully. He has 12 years of enterprise software experience in the life science space.

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