The program is also certified as "validatable" for use in USA Food & Drug Administration-regulated plants. (The purpose of validating software is to meet FDA rules regarding electronic records and electronic signatures, as spelled out in 21 CFR Part 11. The procedure involves extensive testing of the software functions in order to verify that the program performs as intended, and that important security controls are functional. )
Introduced in 1996, ProCal 2000 is used in a variety of industries to establish calibration records, track and schedule activities, and archive data. The powerful program allows data to be segmented among many different companies, departments or sites. It also provides a validation package for FDA compliance. Test instruments are tracked separately and Standard Operating Procedures can be created or pasted into existing database records and printed out during calibration.
With ProCal 2000's highly detailed forms and fields, calibration managers can produce single-page reports that satisfy Good Manufacturing Practices (GMP) and traceability requirements as required for ISO 9000, QS 9000 and FDA Validation compliance.
While PROCAL 2000 makes many types of reports possible, the program is also compatible with Seagate Software's Crystal Reports® for customer-defined enhanced reporting requirements. Prime Technologies also offers custom programming to meet specific needs.
Prime Technologies and its affiliate company Instrumentation Technical Services, Inc. have more than 25 years of combined experience with calibration equipment and procedures. For more information, circle reader service # , or contact Nick Volpone, Director of Sales & Marketing, PRIME TECHNOLOGIES, INC., 20 Hagerty Blvd., Unit #1, West Chester, PA 19382. Phone: (610) 436-9703. Fax: (610) 436-9097.