What is the purpose of regular audits in a laboratory?

• To monitor the temperature and humidity of the storage location

• To restrict access to computerized systems

• To ensure compliance of processes to regulatory requirements

• To review and approve SOPs before circulation

What is the main purpose of traceability in a laboratory?

• To allow for processes to be monitored and errors to be easily detected and rectified

• To ensure that all documents are properly archived and stored

• To restrict access to the storage location of documents

• To review and approve SOPs before circulation

Why should cancellation be managed in accordance to Good Documentation Practice (GDP)?

• To prevent users from using the wrong version of the SOP

• To remove discrepancies of missing entries

• To ensure that all entries into forms are properly recorded and legible

• To detect errors, omissions, and erroneous results

What is the definition of culture in the context of the Quality Management System (QMS)?

• The practices, behavior, and way of life that form the culture in the company

• The completeness, consistency, and accuracy of data throughout the data lifecycle

• The ability to follow the trail of events that has taken place

• The process where the creation, review, modification, issuance, distribution and accessibility of documents are controlled

Why should the document storage location have restricted access?

• To ensure that all documents are properly archived and stored

• To allow for processes to be monitored and errors to be easily detected and rectified

• To ensure that all entries into forms are properly recorded and legible

• To prevent unauthorized removal of the stored documents

What is the main purpose of data integrity in a laboratory?

• To review and approve SOPs before circulation

• To restrict access to computerized systems

• To ensure that all data are complete, consistent, and accurate throughout the data lifecycle

• To monitor the temperature and humidity of the storage location

What is the main purpose of policies and procedures in a Quality Management System (QMS)?

• To allow for processes to be monitored and errors to be easily detected and rectified

• To ensure that all documents are properly archived and stored

• To ensure that all data are complete, consistent, and accurate throughout the data lifecycle

• To set the direction for the company in terms of quality and form the culture in the company

What is the main purpose of document control in a laboratory?

• To restrict access to computerized systems

• To monitor the temperature and humidity of the storage location

• To control the creation, review, modification, issuance, distribution and accessibility of documents

• To ensure that all data are complete, consistent, and accurate throughout the data lifecycle

What is the main purpose of regular audits in a laboratory?

• To ensure compliance of processes to regulatory requirements

• To monitor the temperature and humidity of the storage location

• To review and approve SOPs before circulation

• To restrict access to the storage location of documents

What is the main purpose of traceability in a laboratory?

• To allow for processes to be monitored and errors to be easily detected and rectified

• To review and approve SOPs before circulation

• To ensure that all documents are properly archived and stored

• To restrict access to the storage location of documents