In today’s digitally growing world, many organizations with no ERP system use different kinds of software, which do not allow the required interaction to prompt the business activities. This absence of ERP also hinders the ways of appropriate customization. Consequently, there can be negative effect on the optimized functioning of a business organization. However, large number of issues and challenges occasionally follows selection and implementation of ERP as well. So, you need to prepare yourself for them along with determining a suitable strategy for solutions if anything goes wrong.
Food and Drug Administration (FDA) legislation is enforced to control the standard and quality level of safety for pharmaceutical industry. This legislation is broad enough to cover both the distributors and manufacturers. It is necessary for all the distributors to keep an account of inventory recalls and the product is shipped out to which client. However, if they fail to manage these activities, they will be subjected to recalls of shipments and it may risk severe penalties. As a result, ERP solution providers are highly pressured to meet the rigorous demands for the benefit of a pharmaceutical company’s business.
Due to the crucial safety standards, which are clearly put forwarded for the pharmaceutical companies, and increased competition due to industry consolidation and customer related pressure, ERP solution providers must come up with a solution that offers the most favorable support that also meets all the security and legislative factors and standards. Dani Kaplan, who is an expert of ERP solution, suggests that ERP solution providers must have following controls to manage strict safety concerns effectively under the new Safety Act:
- A system is supposed to be capable of keeping a record of shelf life dates and tracking lot control of all the products. This should be done for all the shipments, outgoing and received.
- The manufacturers and distributors should have knowledge of lot numbers through which the customers receive products. This is greatly helpful in case of any recall.
- Through an ERP system, a computer system should be capable of determining the boundary of shelf life of a product, whenever an inventory is shipped or received. If a product being shipped does not meet the standard, product is not permitted to be shipped.
- In case, such product is shipped, it will result in recall. Bills will be doubled, resulting in customers being unhappy.
Kaplan further stresses on accurate lot number control. He says that to have accurate numbers for each product, tracking down the product’s receiver/customer becomes easy. Consequently, manufacturers and distributors will be able to reply to the recall from customers. The staff of the warehouse will be able to track where all the undelivered recalled products are to be found and they can also get rid of them from the shelves in an orderly fashion. Reports of those products that were recalled should always be present for the inspector from FDA in order to prove that products that were recalled were returned and all the products in the warehouse that were not shipped were taken off the shelves and were destroyed or will be destroyed soon.
There is more than enough proof that suggests that ERP software can also address a key concern that is bar-coded labeling. If pharmaceuticals upgrade their ERP software, they can constitute better understanding and control of all the products that are received in warehouse, in case products are bar code labeled. If the received product does not have a bar-coded label, the client who will receive the inventory can print the bar-coded label from a barcode printer, which is attached to his belt and paste it on the product. Recently, the products can be placed at a random or designated location and the computer records will automatically be updated by the location and also by scanning the bar-coded label on the product.
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