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

1. For medical device companies, software validation is currently required if the software is a part of a production process or the quality system.

2. Software validation must be performed according to an established protocol.

3. Validation is NOT required for Commercial Off-the-Shelf (COTS) software used in data handling.

4. The software lifecycle development process includes the following stages: Requirements, Design, Implementation, Test, Installation, Operation & Maintenance, and Disposal.

5. Data security is only an issue in software systems designed to handle clinical trial data.

6. After August 20, 1997, it will be permissible to use electronic signatures as equivalent to handwritten signatures in GMP documents with no exceptions as long as all of the requirements of 21 CFR 11 are met.

7. After August 20, 1997, all electronic records that are regulated must be backed-up electronically at regularly defined intervals.

8. After August 20, 1997, a secure, computer-generated, time-stamped audit trail is necessary for all electronic records used/generated under any records requirements set forth in FDA agency regulations.

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!

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