Bernafon-MAICO Inc. 5/06/97 3. Software revisions have been made without Engineering Change Order (ECO) control, resulting in the distribution of audiometers with unapproved software. ECOs do not include a record of software source code changes and obsolete versions are not archived [21 CFR Part 820.100 (a)(2)]. Software source code is not controlled under the document...Read More

Lack of written procedures to identify quality assurance problems reported in complaints and repair requests; failure of screening repair and serice requests to identify complaints; and failure of engineering change orders to include a record of software source code changes 3. Software revisions have been made without Engineering Change Order (ECO) control, resulting in the...Read More