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Software Solutions: Building Blocks for FDA Compliance

Tue, 12/05/2006 - 10:48am

Many medical device manufacturers have discovered that their choice of ERP and CRM software can play a significant role in their abilities to comply with FDA regulations
 
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.

By Harold Katz
AT A GLANCE
  • Advantages and benefits
  • Features to look for
  • What to avoid
  • Compliance concerns


  • 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.

     
    While
    the FDA
    encourages
    the use
    of
    electronic
    records and signatures,
    not all
    ERP solutions
    support these.

    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 credit control, as well as invoices and credit notes, providing many investigative pathways. By defining and applying customized RMA codes, trends can be ascertained and analyzed for quality control purposes and FDA compliance. With a click, manufacturers should have the ability to see all customer purchases for any specific model by purchase date.


    By defining and applying customized RMA codes, trends can be ascertained and analyzed for quality control purposes and FDA compliance.
     
    According to the FDA, manufacturers must make the determination as to whether the firm’s processes are or may be contributing to defective devices. There are several ways of making this assessment. For example, process validation information should be reviewed to identify defect characteristics and the rate of expected defects of each characteristic for the finished product. If the rate of defects is found to be exceeded during in-process or finished device acceptance, the processes may be out-of-control or were not properly validated.

    Also, the first and last product test results should be reviewed for continuous processes such as extrusion or injection molding, automated soldering, automated filling lines, automated testing, etc., which may show test failures of the last test product.
    Business Intelligence
    Medical device manufacturers must be able to quickly and easily access the information they need to make decisions that impact quality and security. While many organizations have deployed enterprise applications to improve operational processes, these same organizations fail to provide employees with the insight needed to make quality related business decisions. However, a business can use the data from existing systems to create rich business performance information that serves as a knowledge base for decisions that impact FDA compliance. Business analytics (a.k.a., business intelligence) software enables users to create multi-dimensional views of their financial and operational data to determine patterns and underlying trends, gauge performance and reveal new pathways. Business analytics often includes a series of data mining cubes to produce dynamic, general, and enterprise specific metrics, ratios, and analyses. An administrator toolset will typically allow for the manipulation of the cubes) to accommodate requirements, usually without any special on-line analytical processing knowledge.
    Comprehensive Reports
    While the FDA requires the regular submission of compliance reports, the organization can request special reports. Therefore, it is essential that manufacturers of medical devices have the ability to create these reports with minimal effort. While all ERP systems offer report generation, not all enable the easy generation of customized reports. For the ready generation of these reports, it is advisable that the ERP Report Writer module have access to all files and fields within the database, that reports are completely user-definable enabling the retrieval of desired data in a preferred format and that the reports can interface with an Office Automation module for easy e-mail disbursement.
    Electronic Signatures
    The FDA encourages the use of electronic records and signatures, placing a significant burden on the developers and users of data collection, management, reporting, and analysis software in regulated industries.

    Two important components of compliance are the positive identification of the person creating or modifying data records and the use of audit trails for the data and system parameters affecting its collection and management. However, be aware that not all ERP solutions support electronic signatures.
    Single Point of Contact
    The FDA also requires that the customers of medical device manufacturers have a single point of contact for any service or product recall related questions. A knowledge base that includes technical documentation is required to be easily accessed and up-to-date according to standards set forth by the FDA. Here again, medical device manufacturers choosing ERP and CRM software solutions must make sure they are totally integrated and draw from a single database that is updated in real time.

    Unfortunately, most CRM products offer only batch integration in which data entered into the CRM system must be copied after-the-fact or offline into the ERP system. This is a weakness of these systems and precludes the assurance that users are always working with the most current data. For FDA compliance, a CRM system must offer real-time synchronization of its database with the customer, vendor, inventory, order entry, accounts receivable, and accounts payable files of integrated ERP systems.
    Conclusion
    ERP and CRM software solutions can be powerful tools in aiding medical design manufacturers to conform to regulatory compliance. However, not all ERP and CRM systems are created equal. While many software companies offer both, they are not fully integrated and therefore do not provide the needed data medical device manufacturers require to prove conformance. A software solutions provider must offer a fully integrated ERP/CRM 360 degree solution to satisfy the demanding needs of this highly regulated industry. It should facilitate regulatory compliance and the documentation that medical device manufacturers need not only for regulatory compliance, including Sarbanes Oxley and CAPA controls, but also to enhance operational efficiencies and grow profits.
    ONLINE
    For additional information on the technologies and products discussed in this article, visit SYSPRO USA online at www.syspro.com.

    Harold Katz holds the position of technology enabling manager for SYSPRO USA. He is involved in general operations, the effective rollout of SYSPRO marketing objectives, and applying his software expertise to SYSPRO premier end user accounts. Katz can be reached at 714-437-1000 or harold.katz@us.syspro.com.
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