Quiz: MDSAP QMS Control of Quality Records Procedure

1. According to the MDSAP QMS procedure, which of the following best describes the required characteristics of all quality records?

A Legible, accurate, readily identifiable, and appropriately retrievable B Approved by the Project Manager, dated, and stored in MDSAP Box C Digitally signed, encrypted, version-controlled, and archived D Printed, stamped, witnessed, and filed in chronological order

The procedure explicitly states that all records are required to be legible, accurate, readily identifiable, and appropriately retrievable to ensure effective QMS operation.

2. A staff member needs to discard a data entry recorded on an electronic MDSAP document. What is the correct procedure?

A Cross out the data, initial it, date it, indicate the reason, and use MS Word Track Changes B Overwrite the entry with the correct data and submit for supervisor approval C Delete the entry and notify the MDSAP QMS Site Representative via email D Leave the entry blank and add a comment in a separate log file

The procedure requires that discarded data be crossed out, initialed, dated, and accompanied by a reason using the MS Word 'Track Change' feature - ensuring an auditable record of the correction.

3. Which of the following is NOT considered an MDSAP quality record under this procedure?

A Emails used for official government business B Training records for MDSAP site personnel C Meeting minutes from an MDSAP program meeting D Personal papers belonging to an individual not used to conduct government business

The procedure explicitly states that personal papers - documentary materials belonging to an individual not used to conduct government business - are not government/agency owned and are not considered MDSAP records.

4. What is the minimum record retention period specified in this procedure?

A Three years, or as required by the applicable ISO standard B Ten years, in alignment with medical device regulatory requirements C Two years, unless otherwise governed by local regulation D Five years, or as governed by specific regulation and/or policy at that specific site

The procedure states that the retention period will not be less than five years, or as governed by specific regulation and/or policy applicable to a given MDSAP site.

5. Where should audit and assessment reports specifically be filed and stored according to the electronic records maintenance requirements?

A The site's local server, backed up to MDSAP Box B MDSAP Regulatory Exchange Platform-secure (REPs) C MDSAP Box, along with all other QMS documents D A password-protected shared drive managed by the Project Manager

The procedure specifies that audit and assessment reports are to be filed and stored using the MDSAP Regulatory Exchange Platform-secure (REPs), while other documents are stored in MDSAP Box.