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Software Solutions: Building Blocks For FDA Compliance

Without the proper tools and systems in place, ensuring a product is FDA compliant can be an obstacle to experiencing the successful launch of a medical device. It can cause a company to miss out on profits and lose a competitive edge. This article looks at software that will help preserve both a company’s edge and profits.

Medical device manufacturers have long embraced ERP (enterprise resource planning) and CRM (customer relationship management) software systems; however, they have primarily employed them to achieve operational efficiencies as well as further sales and marketing objectives. Today’s sophisticated ERP and CRM systems support a broad set of activities that help manage and coordinate business functions, including production planning, purchasing, inventory control, supplier interaction, order tracking, and customer service. Furthermore, many medical device manufacturers have also discovered that their choice of ERP and CRM software can play a significant role in their abilities to comply with FDA regulations.

While most ERP solutions facilitate controls through the real-time integration of accounting, manufacturing, and distribution functionalities, the challenge is to find a software solution that also offers the necessary modules to facilitate compliance and one which integrates CRM in real-time. The integration of ERP and CRM enables medical device manufacturers to have a single-point of contact for visibility into the most current customer-related data, providing quick and easy access to the information needed to make decisions that impact quality and security

Engineering Change Control
The Engineering Change Control (ECC) process is a user-definable workflow type enterprise sub-system. It can augment or even replace the paper trail that usually accompanies any changes to product design data. By providing mechanisms, audit trails, and archives, ECC functionality gives medical device manufacturers immediate access to documentation on prior product versions. Through this capability, the manufacturer has the ability to address questions relating to product defects in older product versions. Comprehensive ECC documentation also enables manufacturers to easily revert to the production of prior product versions, if necessary, to suit the requirements of a particular customer or conform to FDA requirements.

Engineer Change Orders (ECO), typically the hub of an ECC system, can satisfy a majority of FDA documentation requirements. The ECO cycle is typically governed by user-defined status codes. Each user-defined status is associated with a system status that enables the system to “relate” to the user-defined statuses. Typically, the link between the user-defined status and the system status is not a one-to-one relationship; any number of user-defined statuses can be associated with a single system status. For example, while the system may only recognize the fact that an ECO is “in progress,” users of the ECC system can define a string of statuses through which an ECO must pass during its “in progress” phases. This routing of ECOs through user-defined statuses is achieved by means of a status routing file in which all possible from/to statuses are held.

Also, typically associated with user-defined statuses are events. When an ECO is moved into a status, any associated events are raised. Once an ECO has been raised, the ECC user must identify all products affected by the change—also an FDA requirement. At least one product must be specified before an ECO can be moved from the system status of “new” to “in progress.” A “where-used” query, which includes all routes identified as being under ECC, is provided to aid the user in identifying possible candidates. Also available on the “where-used” query are lists of existing jobs, purchase orders, and sales orders relating to the products. These can be placed on hold manually, if necessary.

When the ECO is moved from “new” to “in progress,” the current revisions/ releases of the Bills of Material (BOMs) and routings for all products listed on the ECO and for all routes flagged as being subject to ECC are copied to separate tables. All maintenance of BOMs and routings for ECC controlled products are performed against these tables.

Advanced Planning and Scheduling
Advanced Planning and Scheduling (APS), often an elective module of an ERP software solution, enables manufacturing management to gain a real-time picture of current shop floor activities. This capability allows the manager to invoke last minute production adjustments to make allowances for absentee workers, machine down times, and bottlenecks, as well as to accommodate rush orders. Typically, APS software provides the ability to run a variety of reports that give managers better insight into factory operations and further compliance with FDA quality controls. These include manufacturing route details, bills of material details, resource usage, cell and work center details, as well as specifics for each machine on the factory floor.

Selected APS solutions also enable manufacturers to define quality items relating to a machine, product, and customer. The data can be manually and/or automatically collected and stored in a database, which can then be queried directly or brought into an analysis tool—an essential for FDA compliance.

The quality monitoring capability enables instant checks for trends and “blips” in the collected data and can be configured to send warnings to other users when processes are going out of tolerance.

Inventory Tracking
The FDA requires manufacturers to have written procedures for identifying products during all stages of receipt, production, distribution, and installation to prevent mix-ups. However, not all ERP systems are equal when it comes to the breadth and depth of inventory tracking. Therefore, it is critical for medical device manufacturers to ascertain whether the inventory tracking module of the chosen ERP solution provides the “bells and whistles” necessary to facilitate FDA compliance. The ability of the system to perform both lot and serial tracking is of vital importance.

A Lot and Serial Tracking module forms a ‘secure file’ of information gained from the entire manufacturing process—from the testing of raw materials through to the completion of finished goods. It is done by recording material movement through receiving, manufacturing, assembly, inspection, stocking, and final dispatch. It provides the ability to trace where a product originated through to where it went with full upward and downward traceability of all inventory transactions. Some of the key features to look for are two-stage receiving, shelf life control of stock, archives of history, bin/lot and serial number cross-referencing, and reject control/ return documentation. A practical feature is the ability to assign lot numbers manually or automatically and that can be either numeric or alphanumeric. The database of information helps to ascertain compliance with FDA quality regulations. The secure file must be fully accessible and non-alterable.

The traceability requirement should not be confused with FDA tracking regulations. The latter requires certain devices to be tracked to the end user or patient through the entire distribution process.

Components of a device subject to traceability requirements must be identified with a control number where appropriate. Therefore, in selecting an ERP system, it is vital that any solution selected accommodate large field lengths. Manufacturers must define which components are to be identified with control numbers and provide justification for those that are not identified with control numbers.

Handling of Returns
Both RMA (Return Materials Authorization) and RTV (Return to Vendor) ERP software system applications can play a vital role in tracking returned or exchanged items sold to customers or bought from suppliers. Typically, the software automatically generates RMA/ RTV tracking documents noting the reasons for the return and/or exchange. The documents are linked with cross-shipments, inventory and c

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