Biotechnology and Pharmaceutical Applications of BellHawk

As a result of its tracking and traceability capabilities BellHawk has been used in both Biotechnology and Pharmaceutical applications. In biotechnology BellHawk has been used in applications such as tracking the multi–step processing and testing of DNA samples. In pharmaceutical manufacturing plants it has been used to track raw materials and finished goods.

While BellHawk was developed to the requirements of 21 CFR Part 11, it has not yet been validated as a replacement for manual batch records in mixing operations. BellHawk tracking systems are customized to the needs of the individual plants. As such, each system must be validated in its intended application.

BellHawk is especially suited to:

1.   Small and mid–sized testing and manufacturing organizations that are looking for much lower cost solutions than are used by major biotechnology and pharmaceutical organizations.

2.   Organizations that only need to track their raw materials and finished goods using barcode or RFID technology and are willing to continue using a manual batch record for the actual production of pharmaceuticals. This does not require FDA validation of the BellHawk software.

3.   Organizations that need a tracking system that is customized to their specific requirements and are willing to spend the additional time on validation and verification, recognizing that purchasing and validating a BellHawk solution is much less costly than other alternatives.

4.   Organizations that can take real advantage of all the tracking and traceability and activity based costing capabilities of BellHawk and are willing to make the extra effort to take advantage of these capabilities.

Some of the features of BellHawk include:

1.    Support for Part 11 electronic signatures though the use of barcoded employee badges plus passwords. Can also be integrated with biometric devices if needed.

2.    Security: access to all data is controlled through user names and passwords.

3.    All transactions are time/date tagged and associated with person performing transaction.

4.    Overwriting of transactions is prevented.

5.    Transactions kept perpetually in the database.

6.    Can log all attempts to misuse system.

7.    Integrated from proven software modules.

8.    Reports of all transactions in human readable form.

9.    Database can be backed up while system is in use. Enables frequent regular backups.

10.  Can be integrated with equipment to capture electronic test and analysis data.

11.  Supports full traceability including who worked on each process step, what equipment and materials were used, what process parameters were used and what test results were obtained.

12.  Supports tracking of materials both at the barcoded individual item level and at the lot container level.

13.  Supports tracking the quality control status of all materials and prevents use of materials that are not QC approved.

14.  Can be customized to only allow authorized personnel to perform certain operations for which they are trained.

15.  Supports tracking of work by teams of people as well as by individuals.

BellHawk Systems has made arrangements with an FDA Validation organization that is willing and able to assist organizations to validate customized BellHawk systems in FDA regulated applications. This includes replacement of manual batch records with automated data capture.

To learn more about BellHawk Systems cost-effective implementation process, please click here.

For more information about how BellHawk Systems can help you with your specific inventory and material tracking solution, please contact BellHawk Systems by clicking on the link below: