The FDA now regulates over 25% of all goods sold at retail in the USA. This includes:
Foods and Nutraceutical Supplements
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. With the advent of terrorism and the formation of the Department of Homeland Security, the FDA has been given the critical role of guarding our food supply against terrorist attack.
The 2002 Bioterrorism Act extends the 1996 HACCP FDA regulations to require that anyone in the food chain be able to trace back the source and trace forward the destination of all foods within 12 hours. This includes tracking people, packaging material, and equipment that comes into contact with the food. It is not economically feasible to do this with pencil and paper data recording and requires the use of computers to capture and store this information.
The materials traceability and QC tracking capabilities of the BellHawk product line, enables food processors and other organizations inexpensively comply with one-step forward, one-step backward traceability mandates.
Any system that is used for electronic data capture in an FDA regulated environment has to follow the FDA 21 CFR Part 11 regulation. When first issued in 1997, the FDA guidance on validation of electronic data capture systems was so stringent that it was uneconomical for most organizations to use computers for this purpose and so pencil and paper data capture became the norm. Realizing its mistake, the FDA issued new guidelines in August 2003 that allowed the trade-off of risk versus cost of systems validation and now permits systems such as BellHawk to be used in FDA applications.
With the release of Version 4, BellHawk became compliant with Part 11 requirements. While BellHawk was originally designed for non-FDA manufacturing, its ability to track the QC status of materials and capture related test band process data, make it an excellent basis for laboratory applications. This is especially true for those organizations that are transitioning from the laboratory to full-scale manufacturing. The new Version V7 of BellHawk provides improved compliance with the Validation and Verification guidance issued by the FDA for Part 11 software through improved security, role-based limitations on the ability to modify data and improved audit trails.
One of the strengths of BellHawk is its ability to capture traceability data. This enables instantaneous trace-back from a problem to all the potential sources of the problem including vendor materials, people, equipment, or QC testing. It also enables a trace forward from the source of the problem to all the customers to whom the affected products have been shipped.
BellHawk makes extensive use of license-plate tracking, including the use of the new GS1 barcode standards and the emerging RFID ISO standards to ensure electronic traceability of all foods, drugs, and other materials. The accurate generation of these labels and identification tags is performed automatically by BellHawk, thereby ensuring compliance with the FDA's traceability requirements.
Please click here to download a PDF a copy of "BellHawk Compliance with CFR 21 Part 11".