PIE Medical Equipment 4/1/96 Netherlands ultrasound

1. Failure to maintain records documenting that production and quality assurance measurement equipment is routinely calibrated, inspected, and checked according to written procedures and to validate software programs by adequate and documented testing, when computers are used as part of an automated production or quality assurance system, as required by 21 CFR 820.61. For example:

a) Manufacturing, assembly and test operations are controlled by paperless routings [purged text]. There was no documentation of the entry and testing of each medical device routing to ensure that the data entered, procedural references, data fields and test specification error codes are in accordance with the Device Master Record.

b) There were no requirement specifications or test documentation for the RS232 serial integration with either the Scanner 200 diagnostic ultrasound system or the Bio-Tek 601 Pro automated safety tester.

c) There were no requirement specifications that describe the intended functions of the complaint, Unix or DOS database systems in terms of data fields, field sizes, field types, screens, sorts, system security, data integrity, data backups and user locations. Testing has not been conducted to assure and verify that the database system performs reliably and consistently.