6 limitations of Isolated PLM software

“If your product designers are located in multiple geographies, they are probably struggling to keep track of the latest product designs, requirements, and engineering changes.”

“The lack of data visibility across the product development lifecycle from vision to production is probably the biggest bottleneck to efficient new product development.”

“When you don’t have access to a single source of data and information, managing changes and improvements becomes a nightmare.”

“By using a PLM software that is not integrated with your QMS and ERP, you end up slowing down the development process and inducing unnecessary risk into the development life cycle.”

These are all quotes we captured from our conversations with several founders, engineering managers, and product development leaders across the medical device and manufacturing sector in the U.S. In fact, these discussions laid the foundation for building CQ’s ProductQuest, a next-generation, “connected” PLM Software with integrated quality and risk management capabilities.

The Fundamentals: The Product Development Lifecycle Has to be Collaborative and Data-Driven

Product lifecycle management refers to the development of the product right from the time of ideation to delivery and even post-delivery maintenance and obsolescence. It requires the coming together of multiple teams, such as the R&D team, product designers, the purchasing team, the operations team, the manufacturing team, the sales team, engineering teams, etc. It requires constant collaboration and communication between the teams and external stakeholders such as suppliers get involved early on as well.

To minimize errors and make the process efficient, visible, and transparent, the workflow must be streamlined and integrated.

The only way to do this right is to use a next-generation PLM Software that seamlessly integrates with other business systems. Needless to add, this has to be flexible, scalable, and customizable. It must be intuitive and simple to use. Most importantly, the underlying platform on which the PLM is built has to be secure, and it must be easy to pull up reports, analytics, and insights.

Isolated or standalone PLM systems are not fully integrated with other critical business systems, such as ERP or CAD software, and may lack the ability to provide end-to-end visibility. This can result in data silos, limited collaboration, and inefficiencies in cross-functional processes, as different departments or teams may use separate, disconnected PLM tools for their specific needs.

Here are some common limitations of isolated PLM software:

Limitation 1 - Change Management is a Major Challenge

Many product teams become preoccupied with what's changing, particularly within their roles and departments. This fixation can hinder their grasp of the underlying reasons for these changes. When it comes to change management in product development, product managers must understand that it is their job to manage people and their emotions while aligning everyone, new and old, to the core product vision.

When product teams fail to align themselves with the broader organizational change vision, they might lack motivation and risk becoming isolated from other departments. This isolation can lead them to focus solely on micro-goals that do not align with stakeholder expectations.

CQ Offering: Integrated Change Management System That Supports Compliance, Efficiency, Documentation, and Risk Mitigation

CQ’s ProductQuest integrates with our EQMS, Change, and Risk Management modules - which enables seamless collaboration and communication on a unified platform for introducing, reviewing, and approving changes. The software is integrated with a quality management solution that can be used to perform change review and approval to ensure all stakeholders are informed, reviewer validation before change implementation is scheduled, risk assessment, cost-benefit analysis, and supply chain implications are identified.

Limitation 2 - Communication Gap Among Team Members

Product development is a collaborative process, one in which different stakeholders are actively involved. When product changes, review feedback, and team changes are not communicated properly, it disrupts the overall product lifecycle. This is fueled by the lack of communication among team members, as they have access only to a segment of the product development process.

This limitation results in a fragmented approach to product development, leading to several challenges. For instance, organizations may struggle to identify bottlenecks, manage costs, optimize resources, or ensure regulatory compliance without comprehensive lifecycle oversight. This can result in delays, increased production costs, and potential quality issues.

The lack of integration between different lifecycle stages can lead to data silos and hinder effective communication and collaboration among cross-functional teams. Without a holistic view of the product lifecycle, decision-makers may make suboptimal choices, impacting the product's overall success in the market.

CQ Offering: ‘Connected’ Cloud-Based Solution Designed for Collaboration and Action Management

ComplianceQuest's Product Lifecycle Solution presents a cutting-edge cloud-based platform designed to expedite your product development journey by fostering seamless collaboration among your teams, all while mitigating risks and cost overheads and ensuring strict compliance. This comprehensive solution encompasses a range of features, including Bill of Materials (BOM) Management, Engineering Change Management, Manufacturing Process Design, Master Parts/Items Lifecycle Management, and CAD Integration.

Limitation 3 - Lack of Efficient Design Controls Affects Quality and Regulatory Compliance

Isolated PLM solutions often lack robust and centralized version control capabilities, hindering efficient product development, team collaboration, and quality management. Version control is crucial in managing product design and documentation throughout their lifecycle as the development process involves several iterations that require timely reviews and approvals. Without a streamlined document management system, users may resort to manual methods such as file naming conventions or folders to differentiate versions without a proper version control system.

As a result, teams may inadvertently work with outdated or incorrect design and documentation versions, leading to errors and inconsistencies in the product development process. This can result in suboptimal product quality, costly rework, delays in time-to-market, and even compliance issues. Incomplete or inaccurate version tracking can make identifying and rectifying issues challenging, impacting the overall product quality assurance process. It can also be challenging to track and understand the history of changes made to a design or document, which is essential for accountability and auditing.

CQ Offering: Closed-loop System with Integrated Audits and Quality-First Approach

ComplianceQuest's Product Lifecycle Management, seamlessly integrated with Change Management Software, facilitates team collaboration and communication within a unified platform for the efficient introduction, review, and approval of changes. This integration streamlines risk assessment, cost-benefit analysis, and identifying supply chain challenges directly within the system. Furthermore, it establishes a centralized document management system with permission-based controls, ensuring robust documentation, version control, and a comprehensive audit trail.

Limitation 4 - As Organizations Scale, Siloes Affect Performance 

Scalability issues are a common challenge associated with isolated PLM (Product Lifecycle Management) software. These limitations can hinder an organization's ability to adapt and grow as its product development needs to evolve. As a company expands its product portfolio or increases the volume of data managed within the PLM system, isolated solutions may struggle to maintain optimal performance. Slow response times and system crashes can occur, impacting productivity. To that end, handling a growing amount of product data, including designs, documents, and revisions, can become cumbersome for isolated PLM software. This can lead to data organization issues, making it difficult to retrieve critical information quickly.

Scaling an isolated PLM system to accommodate a larger user base can be challenging. Adding new users and providing them access to the system may require significant effort, and it can be hard to maintain user roles and permissions effectively. As a company expands, it often needs to integrate PLM with other business systems like ERP, CRM, and supply chain management. Isolated PLM software may not easily facilitate these integrations, resulting in added complexity and potential data silos.

CQ Offering: Secure and Scalable Solution Built on the Salesforce Platform

CQ offers a unified system with modules based on domain expertise and best practices to support businesses with a global supply chain. Built on the Salesforce cloud, the highly secure solution offers permission-based access to relevant documents from anywhere, anytime, improving collaboration speed and efficiency between teams in disparate geographies. This allows businesses to expand in terms of user size and business without additional infrastructural requirements.

Limitation 5 - Cost of Poor Quality (CoPQ)

The difficulty in tracking changes in isolated systems introduces a high risk of nonconformances and noncompliance. Lack of visibility into the processes can make identifying deviations early and minimizing errors challenging. Looping in feedback and improving the design process is also critical to improve product quality and performance.

Isolated PLM software can also be complex as some isolated PLM solutions lack user-friendly interfaces, making it difficult for users to perform tasks efficiently. This complexity can affect product quality as team members are not fully equipped. Organizations may not allocate enough resources for comprehensive training and user support. Inadequate training can leave employees feeling ill-equipped to use the PLM software effectively.  

While PLM systems can benefit organizations, the cost of improper training and lack of transparency and integration can affect product quality. Integrating the systems to enable transparency and onboard training programs to continuous training requirements can make PLM software expensive.

CQ Offering: Designed for Continuous Improvement of Quality KPIs

ComplianceQuest enables seamless integration between the different features, reducing errors, enabling risk identification and mitigation, and improving quality. CQ’s Training Module allows organizations to train employees on time and keep the workforce skilled with constantly evolving changes in the environment. This solution covers data management best practices while emphasizing data integrity, traceability, and version control. It also includes in-depth instruction on the software's features for design collaboration, change management, and document control.

Limitation 6 - Inability to Comply with Changing Regulatory Requirements

Product development in highly regulated industries, including automotive, food and beverage, and medical devices, must adhere to stringent regulatory requirements. Isolated PLMs cannot address evolving regulatory requirements or product design alterations. The lack of communication between teams and a deficient change management system can lead to delays in implementing necessary modifications or an inability to document alterations. This can result in non-compliance issues, regulatory fines, and even potential product recalls.

CQ Offering: Single Solution to Remain Compliant At All Times 

As regulations require companies to produce documented evidence for finished products, investing in PLM software that meets this requirement is a simpler choice. ComplianceQuest PLM assists enterprises in achieving regulatory compliance by adhering to industry standards and regulations. It facilitates adherence to FDA regulations, including 21 CFR Part 11, ISO standards, and other pertinent regulatory frameworks. The software has a centralized document repository with an audit trail that enhances compliance by ensuring strict adherence to specifications and enabling the tracing of root causes in case of any issues.

With this integrated platform in place, organizations can perform effective document management, change tracking, and the establishment of comprehensive audit trails, all essential for meeting and maintaining compliance obligations. As the solution remains relevant and compliant with regulations, compliance officers can always be ahead of their compliance efforts.

To know more about ComplianceQuest’s PLM Solution in detail, visit
https://www.compliancequest.com/product-lifecycle-management-plm/.