Consultant| Canarys Automation LtdBangalore, Karnataka, India
This discussion thread aims to explore the challenges and best practices associated with ensuring regulatory compliance in project management. Managing projects within industries such as healthcare, finance, and construction often requires adherence to stringent regulatory standards and guidelines. Please share your experiences, insights, and strategies for effectively navigating the complexities of regulatory compliance. Let's discuss how to stay updated on regulatory changes, incorporate compliance requirements into project planning and execution, and mitigate risks associated with non-compliance. Your contributions will provide valuable guidance and foster collaboration among project managers facing similar regulatory challenges. Saving Changes...
Early and regular engagement of your control partners is critical to ensuring a quality product or service. The big challenge is that control partners tend to be overwhelmed with operational and project responsibilities and, hence, their involvement can become a critical bottleneck frequently resulting in schedule delays.
As such, a longer term solution is for control partner teams (e.g. risk, privacy) to look at their own organizational structure and staff up as needed while at the same time, project team members should try to grow their knowledge of the more common regulatory requirements affecting their work.
In highly regulated industries, there are often specialist organizations who deal specifically with compliance. The certification process of a new/changed product may be a project itself within a larger project to design the product.
Few others have the ability to stay abreast of all the changes in highly technical subjects, and the processes for changing regulations may span many years. Project managers need to be knowledgeable of how those processes work or they may greatly underestimate the cost and flow involved for new products or ways of showing compliance. They can't be the experts on everything however.
Taking aircraft for example there are different branches of requirements for passenger vs. cargo airplanes, large vs. small, design, manufacturing, flight operations, and continued airworthiness. Within those, there are experts in passenger safety, structural requirements, flight performance, cyber security, electromagnetic effects, health codes, occupational safety, etc. Evaluating a change may start with one expert, who then adds 2 more for review, who in turn each add 3 more. That vetting needs to be done early because as the scope grows, so do the hours required, the risk level, and the time to delivery. You also can't expect to just push the project through because pressuring people with regulatory authority may result in serious consequences, Saving Changes...
Candice ShubbieConsultant| PROJECT40 ConsultingOntario, Ca, United States
Ashwin,
I currently service the Life Sciences industry, supporting IT projects that implement complex manufacturing, quality and supply chain solutions that are subject to FDA, MHRA and EMA regulations. The key to effective project management in a regulated industry is highly dependent on the understanding that Compliance needs to be built in from the start. The project team should be educated on what Compliance truly means and how it affects them. With this understanding comes an understanding of which aspects of governing predicate rule regulations for the product and/or process being implemented, which help to identify risk measures.
The challenges I see within my client’s organization have to do with stakeholder complexity. There is the client (the regulated company who has hired us), the company implementing the software for the client (integrator), and the company performing Validation and Compliance services, or the IVV vendor (us/my client). As an Independent Verification and Validation vendor, it is our responsibility to ensure that the PMs for both the Software Integrator and the regulated company add compliance tasks into the integrated timeline. The key is to build compliance into the project from the start, by ensuring all compliance and validation dependencies have been factored into the software integrators development timeline during the planning, discovery or solution blueprinting phase of the project. Saving Changes...
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