Data Integrity Knowledge Check

This question related to which ALCOA+ principles:

"Does the electronic system prevent deletion of source data files?"

• Accurate

• Enduring

• Attributable

• Contemporaneous

This statement related to which ALCOA+ principles:

“Data must be routinely verified, through repeatable calculation or analysis, to ensure no error is in place”

• Legible

• Accurate

• Original

• Attributable

This question related to which ALCOA+ principles:

"Can data entry be performed only by the authorized personnel? Where can we find who performed this action?"

• Attributable

• Original

• Accurate

• Contemporaneous

Which ALCOA+ principles have been violated as below example?

"I have already checked this production line, tomorrow I will record it"

• Original

• Legible

• Accurate

• Contemporaneous

This question related to which ALCOA+ principles:

“Is a documented process in place to verify and record the integrity and authenticity of the copy when exact or true copies are retained in place of the original GxP data record?”

• Legible

• Accurate

• Original

• Attributable

What does ALCOA stand for?

• Available – Legible – Complete – Original – Accurate

• Attributable – Legible – Contemporaneous – Original – Accurate

• Available – Legible – Consistent – Original – Accurate

• Attributable – Legible – Complete – Original – Accurate

What does “+” in ALCOA+ stand for?

• Attributable – Legible – Complete – Original

• Complete – Consistent – Enduring – Accurate

• Complete – Consistent – Enduring – Available

• Legible – Complete – Original – Accurate

This example related to which ALCOA+ principles:

“In paper records, this could be done through the use of initials, full handwritten signature or personal seal. In electronic records, this could be done through the use of unique user logons that link the user to actions that create, modify or delete data”

• Legible

• Accurate

• Original

• Attributable

This statement related to which ALCOA+ principles:

“Data and metadata should be readable during the life cycle of the data, be stored in an appropriate manner, under the appropriate conditions”

• Complete

• Consistent

• Enduring

• Available

Data Integrity is applied for:

• Paper document and record

• Electronic document and record

• Both Paper and Electronic document and record