The biotechnology industry should be just as concerned about its supply chain as other fields of business. In fact, due to the importance of having the best possible raw materials for making drugs and industrial chemicals, any company in biotech should be even more worried than other companies. A new poll by Bio Fuels Digest, indicates that biotech companies are most concerned about their supply chains, followed by finances.
Medical companies have additionally the regulatory issues coming up, which will require greater traceability than exists at present for many in the industry, according to Medical Device and Diagnostic Industry. The Biotechnology Industry Organization believes similarly that companies need to back up and protect their data, including supply chain data, for 12 years due to research issues.
Biotech and Data Capture
Healthcare is a huge industry. According to MDDI, businesses in healthcare make a total of $3 trillion a year. Additionally, 24 of the Fortune 50 are all invested in healthcare at some point. They are often developing products like artificial limbs or medications for people who need treatment. As more companies become involved with the industry, the Food and Drug Administration, along with other agencies, such as the American Medical Association and the Centers for Medicare and Medicaid Services, are stepping up their regulatory game. It's becoming harder to enter the field and it's getting more challenging to keep up with the changes in the industry. One of those has to do with traceability. The FDA is going to require drug companies to be able to trace their products from the raw materials to the items of the shelf at the pharmacy for as long as it remains there. The full implementation is supposed to happen within 10 years, according to Securing Industry. Companies must be able to provide unique serial numbers for their products within four years.
Other Reasons for the Importance of Data Capture
Data capture and data protection are both important. They go together because a company can't protect data that it doesn't keep, and it would be a major waste of research not to be keeping as much data about a factory floor as possible. This is particularly true in the biotechnology and the drug industry, in which companies can use spies to steal trade secrets and then sell the products through a generic label.
Thus, on the one hand, a company must be able to track all the information happening in its factories on the chance the information will be useful, and it must also keep this data scrupulously secure.
The best way to go about doing this from the factory and supply chain side is to use data capture with a secure and trusted company that has software which is state of the art and can keep records that are useful from a cost accounting perspective for identifying and reducing variations in the production cycle.
RFID and Barcode Readers
Ultimately, capturing the information generated in a factory comes down to marking each shipment of raw materials as it comes into the factory, and marking the finished products as they come out and go into trucks to be delivered. This can be done easily using barcode reading software. It can also be done with radio frequency identification technology, which works by attaching a separate radio frequency to each item.
By having these items in place, companies can easily find out how a product was put together. This way, if there is a recall, the company quickly determine which part of the product was defective.
From the FDA standpoint, if an auditor asks for a traceability report on a drug, it could readily be given because the information already exists on a secure data server.
Thus, electronic data capture is the first step to keeping information about a biotech factory available, useful and safe.