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Medical Device and Supplies Manufacturing  Applications of BellHawk

Medical Supplies

BellHawk is used by small and mid-sized organizations that manufacture or repair FDA regulated medical devices, equipment and supplies.

BellHawk tracks and traces all the materials that go into the making of these devices or supplies, as well as the people and equipment involved. It also tracks quality assurance inspections and testing to ensure compliance with good manufacturing practices.

BellHawk replaces the use of paper forms and manual keyboard data entry with the use of barcode technology to reduce the amount of labor required for this record keeping as well as preventing mistakes.

BellHawk was developed to be compliant with CFR 21 Part 11 requirements and a data package can be made available to facilitate certification of the system to be in compliance with FDA good manufacturing practices.

BellHawk is specifically designed for use by small to mid-sized organization and costs much less to implement than using materials tracking and traceability systems designed for use by large organizations.

BellHawk:

  1. Tracks materials by lot and serial number and location, as well including enforcing expiration dates, storage requirements, quality control parameters, and hazardous materials status
  2. Tracks what materials were used in the manufacture of which intermediate or finished products
  3. Builds a traceability database to enable rapid tracking back to the source of defects or contamination and a rapid limited recall of resultant defective products.
  4. Tracks compliance with an organization's quality assurance plan by tracking every step of the manufacturing process, including quality control approvals and the collection of test data.
  5. Helps ensure correct labeling by automatically printing product and customer specific labels based on the contents of its database.
  6. Can track testing, repair and calibration activities for medical devices and equipment, including tracking lot and serial numbers of parts used in repair or replacement.

BellHawk is available at an affordable cost on a subscription basis, in the Cloud, through our BellHawk Online service making it especially suitable for suitable for smaller biotechnology organizations and laboratories. BellHawk is also available on a rental basis for installation in a larger organization's own data center.

Please click here for more information about how BellHawk can ensure Compliance with FDA Data Collection Requirements.