FDA / ISO Compliance – ERP Software to the rescue!

Mark Canes

Compliance with FDA requirements can be a big burden on small / medium sized  medical distributors. Personnel limitations, and the need to be nimble, cause many such companies to cut corners, and get caught out when audited and inspected. Yet a well-chosen and properly implemented ERP Software system, providing appropriate Inventory Management and Lot Tracking capabilities, can go a long way in helping companies demonstrate compliance.

Michael Nealon, CFO of Southern Implants Inc. of Irvine, CA, has kindly shared his experience and learning in this blog post.

Product traceability is a huge issue with medical devices with both ISO (13485 for medical devices) and with the FDA. We need to know in very quick order where each unit of every device that either we purchased in a finished state or manufactured has been distributed.

In this regard an effective lot tracking system is essential. The lot information must follow the product through all activities – purchase receipt - manufacturing – sales – returns - consignment transfers -  physical count or other adjustments. Further, the lot information must be easily searchable.

While recalls are very rare, and we have never been in that situation, you must be able to demonstrate the ability to carry out a complete, effective recall using this information at all times.

Another important aspect of the Quality System that both ISO and the FDA assess is the company’s use of data analysis including trending as part of the management review processes. The ability of the ERP to readily produce information relevant to quality matters facilitates effective compliance in this regard. The use of fields in our order entry screens track product warranty shipments which is a very important metric that we follow and report on internally as part of our management reviews. Basic data such as trending sales of different products on a line by line basis and family groups (using category groupings) and within different markets using customer categories is frequently used.

Further, relevant to both the FDA and Health Canada we must have all products approved for sale.  We use fields within the product file of Blue Link Elite to track specifics of the approvals for each product in order to demonstrate that each product sold in either of these markets is approved.

All standard operating procedures (“SOP’s”) are developed with the requirements of both ISO and the FDA being paramount. The ability of the system to effectively control permissions is important to ensure that personnel activity is limited to those functions which they are assigned, based on the activities described in the SOP’s. Manager reviews are important and to the extent that we need to separate the rights of individuals creating transactions such as sales order and purchase orders from the individuals who approve these transactions and post them the ability to use the permissions is crucial.

Product Labeling is a very important matter for medical devices and this area is given a great deal of attention by the FDA in particular. The internal consistency of product label information in terms of product codes and product descriptions appearing on invoices and packing slips is important to ensure that there is no confusion on both our part and on the part of customers ordering, receiving and using our products. The ability to readily import, export and modify both product codes and descriptions in Blue Link Elite allows us to effectively and efficiently audit our product codes and descriptions to ensure the integrity and consistency of this information.

Our process validations, which are a key focus of our SOP’s and of the regulators review, are the product cleaning and sterilization processes. Our processes justify us assigning a particular expiry date on the products which we manufacture. We are required to have a method to track the expiry dates of both product that we manufacture and that we purchase to ensure that we do not sell products which have reached expiry or are nearing expiry. We use fields in Blue Link Elite to populate and track lot expiry dates and we easily developed reports to tell us what product lots are approaching expiry so that they can be removed from stock.

Also, in aid of minimizing the number of product items which approach lot expiry, order entry in Blue Link defaults to pick the earliest product layer (which will almost always have the earliest lot expiry) when choosing lots to fill orders.