Answer each of the following questions with TRUE or FALSE. Good luck!

1. It is not necessary to identify formal specifications before entering the the design phase of software development.

2. Well-documented software specifications will facilitate validation of the system later.

3. If software is a commercial program purchased off-the-shelf, the user is not responsible for performing structural validation.

4. There is little additional benefit to recording actual results when testing software; it is sufficient to record a PASS or FAIL assessment as long as established PASS/FAIL criteria have been set.

5. Formal hazard analysis is beneficial for software used as components in medical devices only.

6. If a software system has been used successfully for many years, it has been proven by experience and documented by use. It is therefore exempt from any requirements for formal validation.

7. Diagnostic tests supplied by the vendor can be helpful in conducting installation qualifications.

8. Systems that control or generate regulated data must be validated for their ability to discern invalid or altered records.

9. Manual audit trails are sufficient to track changes to regulated electronic records, provided that both the date and time of documented changes are recorded.

How did you do? After you have taken the Quiz, request the answers via E-mail from accureg@regulatory.com. If you include your address, we'll send you a pocket book of the GMPs for Medical Devices or for Finished Pharmaceuticals!

Return to The Regulatory Forum

7501 Northwest 4 Street, Suite 210
Plantation, Florida 33317, USA
Telephone: 954-641-6400  Fax: 954-641-6410
Email: accureg@regulatory.com

Contact webmaster

Copyright © 2001 AccuReg, Inc. All rights reserved.
No portion of this site may be reproduced without express written consent of AccuReg, Inc.