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Balancing the Cost of Quality, IT Investments and Integrated QMS

Part 1  of a 4 part series In today’s global manufacturing industry, balancing the cost of quality, IT investments, and integrated QMS (quality management systems) presents as a never-ending series of challenges for your company. Cost of quality is arguably one of your organization’s most important holistic metrics, but too many organizations have neglected the […]



Completing a Final Validation Package in Risk Based Software Validation

Completing a Final Validation Package in Risk Based Software Validation

Part 6: What should be included in my final validation package? So, you’ve gone through the process and are completing the final validation package in Risk Based Software Validation. The question now is, what should be included in the final validation package? Consider the need for documentation which provides evidence that you completed your validation, […]



Harmonizing QMS with Business Management Systems - Part 2: MOM Systems Benefit from QMS Integration

Harmonizing QMS with Business Management Systems – Part 2: MOM Systems Benefit from QMS Integration

Not surprisingly, manufacturing operations management (MOM) systems benefit from QMS integration. Sound quality management systems touch every level of your organization from conception to post-market monitoring. In an ideal scenario, closed-loop quality management principles can increase your company’s ability to respond to and mitigate quality issues early in the design process. However, this situation is […]



What are Qualification Protocols in Risk-Based Software Validation_IQS

What are Qualification Protocols in Risk-Based Software Validation?

Part 5: What about Qualification Protocols and Execution? The goal of software validation is to document that your system works as intended and having gone through the steps discussed in earlier blogs within this series, we can now develop and execute the necessary qualification protocols in risk-based software validation. There are two qualification protocols that you […]



Harmonizing QMS with Business Management Systems - Part 1 QMS + PLM Systems_IQS

Harmonizing QMS with Business Management Systems – Part 1: QMS + PLM Systems

In all likelihood, your company has already encountered difficulties harmonizing quality management systems (QMS) with product life cycle management (PLM) systems. Synergies between engineering, manufacturing, supply chain management, and service will not materialize on their own — even in a closed-loop QMS. In part one of this three-part series, integration between QMS and PLM steps […]



Creating a Business Case to Justify a Quality Management System_IQS

Creating a Business Case to Justify a Quality Management System

Creating a business case to justify a quality management system (QMS) depends on approaching the problem holistically. Every stakeholder in the value chain must buy into the business case you present to justify QMS implementation and maintenance costs. At the very least, your business case should include these elements: organizational alignment/impact of quality stakeholder engagement […]



Top Five Quality Management Issues Facing the Manufacturing Industry_IQS

Top Five Quality Management Issues Facing the Manufacturing Industry

The top five quality management issues facing the manufacturing industry most likely reflect those of your own. However, what can give your organization an edge over competitors is the ability to integrate quality management processes into a closed-loop quality management system (QMS). To stay on top of the latest quality management issues facing the manufacturing industry […]



Utilizing Scripts in Risk Based Software Validation_IQS

Utilizing Scripts in Risk Based Software Validation

Part 4: Where are my scripts? So now that you have your Process Flows, you’ve done our Risk Assessment, and you’ve defined your Functional Requirements you’re ready for the Installation, Operational and Performance Qualification Protocols (IOPQ). You may be thinking, “But this is an Off-The-Shelf software!” So, shouldn’t there be some scripts already developed that […]



Risk Assessment in Risk Based Software Validation_IQS

Risk Assessment in Risk Based Software Validation

Part 3: Assessing the Risks and the Mitigations In the previous blog, we looked at identifying the software touch-points. Now we can take a look at assessing the risks and the mitigations we have in place and identifying additional necessary mitigations in order to ensure that we manage those associated risks – aka the Risk […]



 

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