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quality and compliance

Manufacturing Software Helps Ensure Quality and Compliance

Process manufacturers in the food, chemical, and nutraceutical industries often use generic applications such as ERP software to manage their operations. 

Although ERP software supports these companies’ “front office” needs—including accounting, human resources and marketing—many process manufacturers who use ERP software find that it does not adequately manage the unique characteristics of their formulas, ingredients, and finished goods. 

In this blog post, I discussed how to process manufacturing applications are more effective than generic discrete manufacturing applications in terms of quality and regulatory compliance.  

Quality is of utmost importance. 

Quality control is a critical factor in process manufacturing applications. These applications come preloaded with a library of industry-specific quality-control tests and special instructions that can be applied against raw materials, work-in-progress (WIP) products, and inventory in storage (e.g., stability tests). The user can use an unlimited number of quality statuses for raw materials, intermediates and finished goods based on the results of QC tests.  

In a failed inspection, ingredients must be added to work-in-progress (WIP) until the batch passes. This process may require multiple cycles of adding new elements until the product meets specifications. Applications used in process manufacturing tightly control the rework process, capturing all variances and inspection results.

Manufacturers may need to recondition batches that have failed an inspection by adding new ingredients to the WIP. Multiple cycles of adding new elements may be required for rework until the product passes inspection. Applications used in process manufacturing tightly control the rework process, capturing all variances and inspection results.

Regulatory Compliance  

Many industry-specific documents and audit reports are created in process manufacturing applications, including but not limited to FDA nutritional fact panels, nutraceutical supplemental panels, pharmaceutical electronic batch records, and chemical SDS reports and labels.  

Lot Traceability and Recall  

Lot inheritance is a critical ERP function that keeps track of the history of raw materials and finished products, including co-products and by-products. Ingredients present in minuscule amounts in a finished good must be tracked and traced, which is a critical requirement for chemical and pharmaceutical companies.  

As part of meeting lot traceability mandates, companies must be able to track raw materials, intermediates and finished goods.

Lot traceability in many software applications provides only a “one up and one down” snapshot of information about a product. Graphical traceability maps, however, can be used to perform bi-directional lot traceability searches and product recalls in minutes, exceeding the FDA/GHIS and large retailers’ time limits for such activities.  

When manufacturing software architecture is built from the ground up for food, chemical, nutraceutical or pharmaceutical environments, it can help companies avoid costly modifications, unnecessary workarounds and risks that come with running a discrete manufacturing ERP application in process manufacturing environments. 

How Acumatica Can Help You 

Acumatica’s cloud-based ERP solution offers a range of features to food and beverage manufacturers, including inventory management and control, employee hiring/retention, quality assurance, and much more. Tayana Solutions is a Gold Certified Partner of Acumatica. 

With a focus on production management, process manufacturing, and quality control software, we provide software consulting services to the manufacturing industry. Please visit www.TayanaSolutions.com to learn more about our products and services. 

What is process-oriented quality?

Process-oriented quality management has a long history of development, which is an ongoing process that requires constant evaluation and improvement.

What is quality control in the manufacturing process?

In manufacturing, quality control is a process that ensures customers receive products free from defects and meet their needs. When performed correctly, it can ensure consumer safety.