The FDA now regulates over 25% of all goods sold at retail in the USA. This includes:
Food and Beverage Products
Pharmaceutical Rx Products
Over the Counter Pharmaceuticals
Medical Devices and Supplies
Blood and DNA products
Anything that comes into contact with the human body, such as bandages or suntan lotion.
Anything used in the manufacture or packaging of any of the above items
An ever increasing number of manufacturers and distributors are finding themselves coming under the jurisdiction of the FDA as some or all of the products they sell end-up being used in FDA regulated applications.
Failure to be able to produce complete end-to-end traceability records within 4 hours (or less) that enable the recall of just the defective products can result in recalls of all FDA regulated products made in, repackaged, and/or distributed by the facility in the last 3 years. This can be incredibly expensive and has driven many smaller organizations into bankruptcy.
Complying with the materials tracking and traceability requirements of the FDA by manually capturing the traceability data on paper forms and then keying this into a computer program, such as Excel, can be a labor time consuming and mistake prone process. An industrial employee now costs well in excess of $5,000/month and manually capturing data to meet FDA requirements can easily consume the time of one or more full-time equivalent people.
By using BellHawk Online, clients are able to automate the Track & Trace data capture process and be able to recall materials trace-back and trace-forward data on-demand, typically for under $1,000/month. Clients can also immediately produce reports showing that all the appropriate quality control checks were performed.
The needed data capture can be performed by existing employees, using barcode scanning and mobile computers, with minimal impact on their time or productivity. In fact, in may cases, we have seen productivity gains of 10% or more, due to better monitoring of the production processes.
BellHawk Online meets the requirements of CFR 21 Part 11 enabling it to be validated as part of an FDA cGMP process.
BellHawk Online is compliant with GS1 barcode labeling and supply chain data exchange standards.
BellHawk enables clients to be compatible with the FSMA (Food Safety Modernization Act) and the DSCSA (Drug Supply Chain Safety Act) plus many other regulations relating to product safety and to exchange needed supply-chain tracking and traceability data with their customers. For information about these FDA compliant applications, please see www.BellHawkComplaince.com.