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- Kardex Group
Medical Device Manufactures are required to meet the quality system regulations as mandated by the Food and Drug Administration (FDA). The FDA establishes record keeping requirements and mandated quality control processes. Medical device manufacturers must establish and maintain procedures to ensure that mixups, damage, deterioration, contamination or other adverse effects to products do not occur during handling. The regulations go on to require control of storage areas to ensure that no obsolete, rejected or deteriorated product is used or distributed and that items be stored in a manner to facilitate proper stock rotation. In addition, procedures must be established to ensure that only those devices approved for release are distributed.
While these regulations are clear and straightforward in their requirements, Medical Device Manufactuers are on their own in determining the best way to meet these requirements.
Kardex Remstar systems provide the processes and efficiencies demanded by leading Medical Device Manufacturing organizations from receiving to quality control to manufacturing processes to distribution and shipping.
When used in conjunction with Power Pick Global inventory management and control software, these vertical storage and retrieval systems automate and provide electronic documentation for stock rotation programs and ensure that expired devices are not shipped. The software and system combination allows the segregation and tracking of non-conforming products and prevents accidental release of quarantined items.
Part validation requires order pickers to scan a bar code to verify the part serial number, ensuring that they have picked the exact device required from inventory. Bar code verification routines assure picking accuracy and can be set up to verify items by material, location, lot or serial number. Bar code verification also allows tracking of non-conforming items and prevents accidental release of items on hold. The resulting improved inventory control can reduce operating costs.
Using the traceability feature in Power Pick Global inventory management software, each medical device picked from inventory is documented and can be easily traced back to the original order when necessary, allowing the manufacturer to know who purchased each serial number. Power Pick Global software provides lot and serial number control and full traceability that automates and documents proper stock rotation policies.
Expiration date handling assures that expired items are never shipped. Power Pick Global software offers a range of detailed pick and put activity reporting, including complete histories of all transactions by user ID, date/time and material identification. Reports can be filtered, sorted and printed.
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