ERP & FDA Validation: The Benefits of an Integrated QCS

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In this special blog series, ERP Software & FDA Validation, we’ll discuss the advantages of using an ERP system in an FDA-regulated industry. From organizing mission-critical documents to vendor management, you’ll learn how ERP helps keep product timelines in place and manufacturers in compliance.

From managing suppliers to delivering on your customer’s expectations, quality is a responsibility that is fulfilled by everyone at your organization, whether they realize it or not.

As materials move through the production chain, quality-related activities must be completed to ensure a successful product release. Access to and transparency of these procedures in your ERP system through an integrated quality control solution (QCS) promotes the importance of quality in your daily operations and supports compliance throughout the manufacturing process.

Benefits of an Integrated QCS | The Copley Consulting Group

Here are three key benefits of purchasing an ERP system with integrated QCS.

 Quality-Focused Culture

We have all been a part of annual employee trainings. Each year, you’re asked to watch a video and/or take a quiz to test your knowledge of a given topic. For manufacturers working in a regulatory space, the responsibility of quality bears consequential significance – and, as such, requires more than the periodic refresher course.

QCS allows manufacturers to make quality an intrinsic component of their company’s daily operations. With quality functionality built into your ERP system, employees will understand their role in upholding the quality of your products and, through automated workflows and checkpoints, will be held accountable for doing so. From receiving and production to shipping and returns, your workers will have the ability to flag nonconforming materials, record associated issues and notify appropriate staff members as efficiently as possible.

As an example, with Infor CloudSuite Industrial and implementation services from Copley, Pine Pharmaceuticals moved away from their manual quality system and inventory processes to an automated system. Pine was also looking to put a more formal purchasing and planning system in place that they were missing previously.

“With the continued growth of our company we needed to have a solution in place that could improve our processes to support this growth, while also helping us meet FDA requirements. With Copley we have the support we need to get the solution up and running to automate all of our processes and accelerate the recent success we’ve had here at Pine.” Alfonse J. Muto, President of Pine Pharmaceuticals

 

Continuous Improvement

Your methodology for ensuring quality should be formalized but, in reality, can never really be set in stone. As technologies evolve and lessons are learned, your approach to quality incidents, change management and audit response will evolve.

Fortunately, QCS can support changes to your procedures, from cause analysis and correction to implementation and prevention. With integrated QCS, your ERP system utilizes a standard process template that can be adjusted at any time. Rollout is a breeze, as the QCS then tracks the completion of each task within the system. For example, should a new review be introduced, you can make that particular review a prerequisite for closing a change management report. This ensures that all quality activities are handled consistently moving forward.

Simplified Reporting

Tracking quality data is a necessary evil of working in an FDA-regulated industry. But using an ERP system with automated reporting can help take the burden off your workers so they shift their focus back to value-added activities.

An integrated QCS simplifies inspection reports for both in-process materials and finished product by allowing your organization to define a set of permissible disposition codes (e.g., cause, failure and defect) to facilitate consistent reporting. In addition, when there is a case of non-conformance or a corrective action is taken, QCS can capture compliance data needed for audits, such as related inspection results and reviews, while measuring the costs of quality/non-conformance to support your day-to-day business decisions. Post-release, in the case of a customer complaint, those using Infor CloudSuite™ Industrial (CSI) benefit from QCS’s ability to sync up with CSI’s Return Material Authorization (RMA) module. This allows CSI to direct a returned product to QC for receipt, inspection, disposition and non-conformance tracking. From there, you can assign a responsible party, track the internal review and corrective action, and gather feedback via the Customer Complaint Reporting (CCR) function – all from within one comprehensive, integrated software package.

 

 

ERP & FDA Compliance

 


Filed Under: Blog, FDA Validated