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Data Integrity Checklist PDF

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244 views

Data Integrity Checklist PDF

Uploaded by

ttugce29
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
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Data Integrity Checklist

Question Comments

A
Paper

Does your company maintain a signature log for employees that


work in GxP areas?

Are staff trained in Good Documentation Practices outlining that GxP


Attributable

records must be initialled and dated?


Is the use of scribes prevalent in your company?
Are digital images of a person's handwritten signature permitted at
your company?
Electronic
Does the system use unique user logins with electronic signatures?
Are there audit trials in place recording the identity of operators
entering, changing, confirming or deleting data?
Does the system identify and record the person releasing or
certifying the batches? Is an electronic signature used?
Are staff trained on the fundamentals of data integrity which
emphasises never to disclose their username or passwords with
other staff?

© 2016 PharmOut. This document has been prepared solely for the use of PharmOut and its clients. Copying is prohibited.
Page 1 of 5
Data Integrity Checklist

Question Comments

L
Paper

Are controls in place to ensure data is recorded using permanent,


indelible ink?

Is the use of correction fluid, pencils and erasures prohibited?


Legible

Is there controlled issuance of bound, paginated notebooks for GMP


activities?
Are archiving of paper records performed by an independent,
designated archivist?
Are operators trained to use single-line cross outs accompanied by
an initial and date when recording changes to a record?
Electronic
Is your stored data checked periodically for readability?
Are audit trails convertible to a generally intelligible form?
Can general users switch off the audit trail?
Is archived data checked periodically for readability?
Is data backed up in a manner permitting reconstruction of an
activity?

© 2016 PharmOut. This document has been prepared solely for the use of PharmOut and its clients. Copying is prohibited.
Page 2 of 5
Data Integrity Checklist

Question Comments

C
Paper

Are staff trained in Good Documentation Practices emphasizing the


importance of recording data entries at the time of activity?

Are staff trained in Good Documentation Practices emphasizing that


Contemporaneous

it is improper to back date or forward date a record?


Electronic
Does your system automatically generate a timestamp when data is
entered?
Do electronic signatures contain an automatically generated
timestamp?
Are users able to change the timestamps applied to records?
Are general users able to gain access and change the system clock
or timezone settings?
Is data saved to unauthorised storage locations such as USB sticks?
Are there sufficient availability of user terminals at the location
where a GxP activity takes place?

© 2016 PharmOut. This document has been prepared solely for the use of PharmOut and its clients. Copying is prohibited.
Page 3 of 5
Data Integrity Checklist

Question Comments

O
Paper

Are sticky notes or other unofficial notepads permitted in GMP areas


of the facility?

Are qualification/validation activities performed on original pre-


Original

approved protocols?
Is there a controlled and secure area for archiving of records?
Are original records readily available for inspection?
Electronic
Is it possible to print out batch release records, showing any data
that has been changed since the original entry?
Are your electronic signatures permanently linked to their respective
record?
Does the person processing the data have the ability to influence
what data is reported or how it is presented?
Does the system prevent deletion of original data?
Is it possible to take screenshots and use snipping tools to
manipulate data?
Is metadata periodically reviewed?

© 2016 PharmOut. This document has been prepared solely for the use of PharmOut and its clients. Copying is prohibited.
Page 4 of 5
Data Integrity Checklist

Question Comments

A
Paper
Are forms, logbooks and notebooks formatted to easily allow for the
entry of correct data?
Are procedures in place to independently review original paper
records?
Accurate

Are deviations and out-of-specification results investigated?


Are laboratory instruments calibrated and maintained?
Are secondary checks performed to check the accuracy of critical
data?
Are staff pressured into meeting production targets, leading to
compromised accuracy of records?
Electronic
Do interfaces contain built-in checks for the correct and secure entry
and processing of data?
Does your system perform a check on the accuracy of critical data
and configurations?
Are systems periodically reviewed?
Are interfaces validated to demonstrate security and no corruption
of data?
Is archived data protected against unauthorised amendment?

© 2016 PharmOut. This document has been prepared solely for the use of PharmOut and its clients. Copying is prohibited.
Page 5 of 5

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