Audit Checklist for Data Integrity Page No.

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Audit Checklist for Data Integrity

Auditing Department: ________________ Date of Audit: __________________
Name of Auditor(s) Department Signature & Date
1
2
3
Sr.
Assessment Question Guidance Observation Remark
No.
1. Documentation & Record:
1.1 Is the logbook/ records paginated All the activity shall be recorded in
and issued by QA? the
paginated logbooks and issued by QA
1.2 Is doer of the activity recording the The documents shall be Attributable
observation / parameter with sign to the person generating the data
/date and time (as applicable)?
1.3 Are the data entries being performed Document shall be Legible and
with indelible ink (with color of ink permanent.
as defined in SOP) and readable?
1.4 Is any scribe used for making data Should only take place where the act
entries? of recording places the product or
activity at risk and mentioned in
SOPs.
1.5 Are the required entries in the log Document shall be Contemporaneous
books/batch documents/ Analytical
sheets made on time and available?
1.6 Is the information/ data available in Document shall be Original
original record or certified true
copy?
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1.7 Is any editing to errors performed in The document shall be Accurate

logbook/ document without
documented amendment as per
SOPs?
1.8 Are logbooks/ documents has All documents shall have a unique
reference of unique identification identification number (including the
number as defined in SOPs? version number) and shall be
checked, approved, signed and dated
(as applicable)
1.9 Is there any blank formats (including All blank formats (including SOP
SOP formats, Logbooks, note books, formats, Logbooks, worksheets,
worksheets) found in area which is laboratory notebooks) shall be
not issued by the quality unit? controlled by the quality unit
1.10 Are logbooks/ documents has Documents should be stored in a
reference of format no. as defined in manner which ensures appropriate
SOPs? version control
1.11 Is soft copy Master document is Master copy (in soft copy) should be
accessible at prevented from unauthorized or
computers? inadvertent changes
1.12 Are there any obsolete format/ SOP/ Updated versions shall be distributed
document available or in computer? in a timely manner.
1.13 Is there any blank space left in filled Entry of 'NA' placed in blank space
page of (if required) followed by sign / date.
log book/ BPCR/ DRS etc.
1.14 Is there enough space provided in Documents should be
logbooks/ BPCR/ DRS etc. in which Contemporaneous
the manual activities are recorded
should be ensured.
1.15 Is 24 hr (HH:MM) time format Time format should be HH:MM (24
being used in documents? hour format)
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1.16 Are clocks/ timer designated in area Clocks/ timer should be synchronized
easily accessible to note the timings and easily accessible. Documents
by doer? should be Contemporaneous.
1.17 Are clocks/ timer designated in area Clocks/ timer should not be easily
easily accessible to be changed/ accessible to be changed/ modified
modified by any person? by user.
1.18 Is the correct unit of measurement is Significant unit of measurement shall
used while recording: temperature/ be used as per requirement.
weight etc.?
1.19 Are critical activities signed by doer Doer and checker provision shall be
being checked by another person in place for critical activities. Data
(wherever applicable)? should be Accurate and Original
1.20 Are print outs (e.g. autoclave, Records shall be checked, and cross
balance etc.) duly signed by doer reference shall be available. Data
and checker and have cross should be Accurate
reference to the original / mother
document?
1.21 Are print outs which are on thermal Thermal paper printouts shall be
paper being photocopied prior to photocopied and dully signed. Data
attachment? should be Legible
1.22 Are the procedures of document Data review procedures describing
review available and followed? review of relevant metadata should
be available (as applicable)
1.23 Is archival of paper records not Archival of paper records by
performed by QA in secure and designated
controlled archives? personnel in secure and controlled
archives
1.24 Is the observation being recorded as Digits for data shall be visible from
visible in the display on equipment/instrument display.
instrument/equipment screen/
PLC/HMI etc.?
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1.25 Are entries in logbooks sequential, Entries should be sequential, reliable,

reliable, complete and legible.
complete and legible?
1.26 Is transcribed data verified against Document should be original. If
the raw transcribed cross reference of mother
data for correctness and accuracy? document shall be mentioned.
1.27 Is there any unauthorized changes Unauthorized changes should not be
observed in the document? done in the documents
1.28 Is whitener/ opaque substance/ Data should be Legible
eraser / white tape or whiteouts etc. (No usage of opaque substance)
used in document for correction?
1.29 Are corrections not initially signed Corrections shall be justified with
with date sign and date.
and properly justified?
1.30 Is there any partial correction of No partial correction of numerical
numerical value? value. Data should be Legible
1.31 Does signature log for employees Log should be available and
available? maintained
2. Electronic Data:
2.1 Are individual Login ID and unique Individual login ID should be
password assigned to individual? assigned for individual person.
2.2 Is user creation, authorization list List shall be available for individual
available for the system defining equipment and access levels should
access levels? be defined.
2.3 Does Audit trail contain following Audit trial should contain the
details, attributes
- Name of the person who
performed the activity
- Description of the activity
- Time and date of the activity
- Justification in case of any
changes made
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2.4 Does electronic data saved at the Data shall be saved at the time of
time of the activity and before activity. Data should be
proceeding to the next step of the Contemporaneous and Original
sequence of events?
2.5 Is the audit trail secure and time- Audit trail should be secured and
stamped that independently record time-stamped.
operator actions?
2.6 Is privileges given to any person to Data should be Legible and access to
overwrite the original data? overwrite the data should be
prohibited
2.7 Are electronic records archived by Archival of electronic records by
any person in random manner? designated
person in secure, controlled and
reproducible electronic archives
2.8 Is there any provision available to System should not allow to change
change time/date of system by doer/ the time and date.
checker?
2.9 Is time/date of system synchronized Time/date of system should be
across the GXP operations? synchronized
2.10 Does audit trail reviewed in routine Audit trial review procedure should
data review/ approval process? be available.
2.11 Does relevant meta data reviewed Relevant meta data shall be reviewed
along with original electronic data? with original data.
2.12 Is data review signified by As per approved procedure and
electronically system limitations as validated.
signing the electronic data &
metadata?
2.13 Is computer system validated and Validation should be available.
controls/ setting tested, locked and
protected from unauthorized access?
2.14 Does the system validation Validation should be available.
documentation include established
controls to ensure data integrity
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(data security- access

roles/permissions, sequence of
operations, enabling of relevant
audit trail)?
2.15 Are the standards for the system’s Computer system validation
password strength and complexity document should be available with
defined and documented within password complexity.
system documentation
(requirements, and testing)?
2.16 Is there a defined password Password expiration should be
expiration that is enforced by the enforced.
system?
2.17 Is data retained in a non-editable Approved procedure should be
format or PDF format etc.? available for back-up and storage
2.18 Are back-up copies of original Approved procedure should be
electronic records stored in another available for back-up and storage
location as a safeguard in case of
disaster?
2.19 Are periodic tests performed to Approved procedure should be
verify the ability to retrieve archived available for back-up and storage
electronic data from storage review
locations?
2.20 Is archival copy compared with the Approved procedure for archival of
original electronic data to confirm data should be available.
entire content and meaning of the
original record?
2.21 Are time/date and done by/ checked Records should be available in form
by printed on records electronically? of time and date stamped records and
signed.
2.22 Is authorization to verify data Authorization to generate data shall
separate from be separate to authorization to verify
doer? data
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2.23 Is restoring of Back up Computer system validation shall

data/Archiving Data validated and demonstrate.
regularly tested?
2.24 Does a list of computerized system The name, location and primary
available? function of
each computerized system should be
available.
2.25 A list of currently approved users, List shall be available for individual
specifying the users name and equipment.
surname, and any specific
usernames should be available.
2.26 System administrators should be preferably IT personnel
independent from users performing
the task
2.27 Can general user switch off the audit System should not allow to change
trail? the settings

3. Personnel Training:
3.1 Is Training record for data integrity All personnel should be trained on
and cGMP available? data integrity concept and cGMP
3.2 Is Training record available for All personnel should be trained on
related SOPs related SOPs as per job assigned
as per job assigned?