When medical device manufacturers refer to business process improvement, they are typically discussing its physical implementation versus the approach an organization might take to optimize its processes to achieve efficient results. 

Assuming things are in place, the challenge then becomes two-fold: physically defining the workflow and the data flow.

How to Define a Workflow

When defining the workflow, outlining business processes from beginning to end is the goal. It is essential to design these flows with the end user’s needs and goals in mind while also considering current system inefficiencies and creating new solutions. One of the key success factors for process manufacturers is recognizing the quality characteristics of goods during the various stages of their life cycle.

Fine-tuned to meet your industry requirements, Sage Enterprise Management (Sage X3) provides advanced functionality to help your business remain competitive in the face of the current marketplace.

How Sage Enterprise Management Can Help

Sage Enterprise Management offers a fully integrated quality control process, providing a convenient and efficient way to gather and monitor important process information. It tracks and maintains quality specifications and test results for raw materials, in-process goods, and finished goods. As batch production runs of finished goods are completed, test results are recorded and stored with production history and other details. 

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User and System Requirements

After you've developed user requirements, you can look at the system requirements specifications. System requirements specifications are designed and developed with the business process in mind. It's important to write user and system requirements so that they are testable. Ultimately, the Technical System Design is established, which allows you to configure the system so it meets the Systems Requirement Specification as well as the User Requirements Specification. As in most cases, User Accepting Testing gives you the opportunity to verify whether or not you've met business process design needs. The full process truly allows for the alignment of your enterprise system through procurement, manufacturing, sales, distribution, and accounting.

Auditing

Other elements to consider are the associated audit trails, whether that's ensuring compliance with Sarbanes-Oxley or FDA computer system validation requirements. From a practical perspective, an integrated audit trail allows a business to understand what changed, when, and by whom. It also provides controls for product item master, cost changes, and a historical record of transactions.

How is your business managing product quality, resources, and inventory? Are you stuck using manual processes and clunky Excel spreadsheets that provide an inaccurate view of your environment?

Contact Southeast Computer Solutions today to learn how you can eliminate and minimize the manual processes and other challenges that prevent your business from maintaining industry compliance and increasing profits.

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