Initially designed to uphold the pillars of document control and consistency, MasterControls’s InfoCard system was a decent starter kit for the regulatory obstacle courses of life sciences.
But as we sprint into the complex future of closed-loop quality management, MasterControl’s rudimentary QMS tools are wobbling under the industry’s evolving demands.
This leads us to the topic of this blog post: MasterControl’s representation of a Bill of Materials (BOM).
MasterControl has tried to shoehorn a product view by connecting several “InfoCard” documents into a broader operational QMS framework, but this approach reveals a fundamental misunderstanding.
MasterControl is just another of the many eQMS providers that have failed to add a fully integrated BOM. MasterControl's non-PLM-based infantile BOM setup reflects a lack of sophistication necessary for true closed-loop product quality.
Their core architecture is missing the complexity and finesse required to handle the dynamic product quality demands of today's industries, particularly in life sciences, where compliance, regulatory, and product intricacies converge.
From the digital transformation story of MaryRuth Organics, a former MasterControl user, on why their quality team felt compelled to make the switch to Propel:
“The [Propel] software addressed MaryRuth’s challenges through its bill of materials feature. This functionality visually links the main product record (parent) to essential documents in the product development process (children). This streamlined approach—incorporating details around specifications, labels, raw materials, and more—enhances efficiencies by eliminating the need to *sift through countless folders.” Read MaryRuth’s story here.
The Fundamental Misalignment in MasterControl's Approach to BOM
As we unpack the deficiencies within MasterControl's BOM system, it's essential to spotlight how these shortcomings affect users, particularly those in highly regulated industries. The platform's basic architecture not only limits the efficiency of day-to-day operations but also increases the risk of compliance breaches and operational oversights.
Each of the following points illustrates a critical area where MasterControl fails to support its users adequately, leading to increased costs, delayed production timelines, and heightened regulatory scrutiny.
What You’re Missing with MasterControl‘s BOM:
1. Inline Redlining in the BOM View at All Levels: MasterControl does not include inline redlining in their BOM. Imagine trying to give feedback on a document by sending separate emails for each comment instead of redlining it directly—that’s the reality we’re talking about. Furthermore, consider not being able to redline BOM items at any level—quantities, cost, or which manufacturers are preferred and alternates. Users must instead navigate cumbersome processes to indicate changes, leading to a higher risk of miscommunication and errors.
In industries where modifications can have significant implications—like adjusting component specifications in medical devices—the inability to visually track and annotate changes directly on the BOM can delay product updates, potentially affecting market responsiveness and regulatory compliance.
2. Real-Time Revision Comparisons: Without the capability to view all revisions in real-time, MasterControl does not have the ability to quickly assess what changed between any given revisions. Users find themselves playing a constant game of catch-up. Imagine finishing up a week-long project only to realize that the blueprint had changed along the way, and you had been looking at an outdated version.
This lack of visibility can lead to costly reworks, production delays, and a strained relationship with regulatory bodies, as every untracked change could mean a deviation from compliance standards.
3. Comprehensive Traceability: MasterControl’s limited traceability across features can create a logistical nightmare. In the event of a quality event or recall, tracing a component’s application across multiple products can be as complex and time-consuming as solving a jigsaw puzzle without a reference picture.
This inefficiency not only increases the risk of prolonged downtime but also exposes companies to higher regulatory risks and potential financial losses from halted sales.
4. Complete Product Structure Capture: The inability to fully capture and navigate a product’s structure within MasterControl is like trying to navigate a city without a map. This can hinder teams from understanding the complete picture of their product's lifecycle, from design to delivery.
Ineffective management of the product structure may lead to inefficiencies in production planning, increased costs due to poor resource allocation, and difficulties in implementing changes or updates effectively across the product line.
5. Integration of Approved Manufacturers List (AML): The absence of AML integration in MasterControl's BOM is a critical oversight. Without access to change-controlled supplier data managed throughout the BOM, procurement teams must manually cross-reference supplier capabilities and compliance, a process fraught with the potential for error.
This disconnection can lead to procurement of substandard or non-compliant materials, jeopardizing product quality and compliance with regulatory agencies and standards.
Propel’s Advanced BOM Capabilities—A Class Above
Propel's BOM management system is a testament to what modern, seamlessly integrated PLM and QMS should aspire to be. With dynamic, real-time collaborative editing, comprehensive traceability, and detailed revisions visibility, Propel's BOM capabilities are engineered to empower teams, not hinder them.
Users can instantly visualize changes with inline redlining and track all revisions and modifications across complex product structures while accessing up-to-date AML data integrated directly into the BOM. This seamless integration ensures that every team member—from design to supply chain—is always aligned with the latest product data, reducing errors and speeding up time-to-market.
Additionally, Propel's integration with SiliconExpert Lookup enriches the BOM management experience by providing real-time market availability, component datasheets, and compliance data directly within the BOM view, facilitating informed decision-making and compliance adherence. This not only saves valuable time but also mitigates the risks associated with component shortages and regulatory non-compliance.
Conclusion
Understanding the shortcomings of MasterControl's BOM features underscores the need for a robust, integrated product quality approach like that offered by Propel. By adopting Propel’s advanced BOM management tools, companies in regulated industries can enhance compliance, streamline product development, and avoid the pitfalls associated with outdated or simplistic systems.
Propel QMS provides not just a solution but a strategic advantage, preparing businesses to efficiently navigate the complexities of modern product lifecycle management and regulatory landscapes. Request a demo to see for yourself how Propel could revolutionize your QMS and BOM processes.
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