The Power of Integrated PLM and QMS in Regulated Industries

Successful product development requires the design and development of products that address the pain points of the intended customers, serve the cost and time objectives efficiently, and meet quality and performance criteria. As product development is an iterative process requiring many revisions and reviews, there is a high risk of nonconformance, deviations, and non-compliance. This can lead to adding direct and indirect costs to the product due to scrapping and wastage, especially if changes happen at a later stage of the product's life.

To make the product as per the specifications and compliant with relevant regulations, businesses need to invest in a quality management system. The QMS must integrate with the product lifecycle management software to lower the cost of quality and ensure quality control assurance right from the beginning.

While PLM software enables businesses to manage certain quality aspects, the benefits are limited. The software’s primary function is to optimize product design, engineering, and documentation aspects. It facilitates effective change management, version control, and configurations to ensure conformance. However, it falls short on aspects such as compliance and process quality.

Integrating the two will benefit businesses tremendously, especially in regulated industries such as medical device manufacturing, as it can lower the cost of products, improve compliance, and reduce non-conformance. It enables extending a closed-loop quality system across the product lifecycle, in addition to the business as a whole. This results in establishing a culture of quality in the organization, ensuring operational excellence across functions and improved customer satisfaction.

PLM vs. QMS - Why Integrating the Two Matters

The PLM typically enables the design and development of a product and covers functions such as:

• Input gathering
• Feature finalization
• Creating the BOM (Bill of Materials)
• Design
• Change Management
• Verification and Validation

The PLM acts as a single source of truth for product specifications, engineering specifications, CAD files and drawings, supplier content, bills of material, quality KPIs, performance testing plans, and data. It consolidates data from a variety of sources such as CAD software, Enterprise Resource Planning (ERP), Manufacturing Execution Systems (MES), and so on.

A QMS is concerned more with

• Reducing non-conformance
• Documentation
• Compliance
• Complaint management
• CAPA and Root-cause analysis
• Risk mitigation

Integrating the two provides visibility and transparency into the product development process and facilitates collaboration across functions to ensure quality at every stage of the product life cycle.  It enables the automation of workflows and facilitates analytics for drawing insights that help with making informed decisions. This improves product quality and accelerates time to market.

Some of the benefits of integrating the two include:

• Product Record for Quality Management: The PLM stores records of all product-related information, which is available for quality management. The revisions made and configuration history help with root cause analysis, improve supplier quality management, and trigger CAPA or SCAR based on the need.
• Product Quality Documentation: The second benefit is in enabling the documentation of quality issues and improving resolutions due to the access to relevant data. Integrating product history with feedback and complaints empowers quality and other functional heads to continually improve processes and compliance.
• Facilitates Root Cause Analysis: Access to PLM data helps with root cause analysis and CAPA, reducing non-compliance and improving product and process quality. This helps identify areas where there is a deviation from SOPs and enforce it diligently. It also helps identify skill gaps and plan and deliver appropriate training.
• Change Management: Change management is a critical aspect of both QMS and PLM. PLM helps with the efficient management of engineering change without compromising quality and minimizing risks.
• Facilitates Collaboration: Quality assurance needs collaboration between multiple functions on a unified platform with improved communication and information sharing. Both PLM and QMS enable this, thereby ensuring all stakeholders work closely to achieve shared goals.
• Risk Management: Regulatory bodies require medical device manufacturers to take a risk-based approach to product development and quality. QMS enables identifying risks, ranking them based on criticality and frequency, and implementing mitigative measures. This improves product quality and minimizes errors, thereby making it cost- and time-effective.

Read our blog Decoding The Three Ds of Product Development Lifecycle - DHF, DMR, and DHR: https://www.compliancequest.com/blog/three-ds-of-product-development-lifecycle/

ComplianceQuest PLM + QMS for Regulated Industries

ComplianceQuest has an established track record as a cloud-based Quality Management Solution built on Salesforce. We also offer a PLM Solution that draws on robust principles of product development and integrates with the QMS for improved product design, development, marketing, customer service, and retirement.

Some of the key features that ensure improved compliance, nonconformance management, and overall product quality and performance include:

• Cloud-based solutions that seamlessly integrate to automate workflow and enable information sharing between the two systems
• Change and risk management that enable assessing the risks associated with the proposed changes and implementing controls where needed
• Access to design history for improved auditing and compliance
• Access to complaints and other downstream data that help improve the design and development process
• Requirements tracing and design controls for providing data needed for root cause analysis and effective CAPA
• Aligning with relevant industry standards and regulations for improved compliance
• Supplier management to minimize nonconformance
• Document and Training management
• Automation of processes to speed up the design, development, and manufacturing processes and minimize errors introduced by human operators

To know more about the ComplianceQuest PLM and QMS solutions, request a personalized demo: https://www.compliancequest.com/personalized-demo/

Watch our webinar exploring the connections between design, design quality, and documentation: https://www.compliancequest.com/webinar/connecting-design-to-documentation/