Good Documentation Practices Pre-Assessment Exam

What does the term "True Copy" refer to in Good Documentation Practices?

• A copy of the original document that is identical and verified

• Any duplicate of an official document

• A scanned version of a paper document

• An annotated version of an official document

According to GDP, what does + stand for in ALCOA+?

• Comprehensive, Consistent, Enduring, Available

• Contemporaneous, Consistent, Enduring, Available

• Complete, Consistent, Enduring, Available

Why is it important to maintain version control for documents, as per GAMP 5 standards?

• To make documents visually appealing

• To manage updates and revisions, preventing the use of outdated copies

• To comply with environmental regulations

• To reduce storage space for documents

In electronic document management, what is the purpose of implementing audit trails?

• To track changes made to electronic documents

• To audit employee performance

• To monitor internet usage

• To enhance document formatting

What is the significance of using secure user access controls in electronic document management?

• To limit access to authorized personnel, ensuring data security

• To simplify the login process for all employees

• To track the location of electronic documents

• To comply with paper documentation standards

How should errors be corrected in a controlled document, according to GDP?

• Erase the incorrect information and write the correct details

• Draw a single line through the incorrect information, record the correction, and sign and date

• Ignore the errors, as they are minor

• Create a new document with the correct information

What is the purpose of periodic verification in the context of true copies?

• To increase document storage space

• To ensure true copies remain accurate and up-to-date

• To create new versions of documents

• To reduce document retrieval time

Why is it necessary to implement digital signatures in electronic documents, as per 21 CFR Part 11?

• To add a decorative element to documents

• To comply with international postage regulations

• To enhance document readability

• To ensure the authenticity and integrity of electronic records

What role do personnel training programs play in GDP?

• To increase document storage space

• To enhance employee skills in using automated testing tools

• To ensure correct procedures are followed in document creation and maintenance

• To reduce the number of documents generated

What is the primary purpose of a Process Deviation Form in GDP?

• To track employee attendance

• To report and document any deviation from a documented process

• To record the history of a document

• To measure document storage efficiency