Auditing
Department: |
Date of Audit: |
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No. |
Name of Auditor(s) |
Department |
Signature &
Date |
1 |
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2 |
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3 |
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Sr. No. |
Assessment Question |
Guidance |
Observation |
1. Documentation & Record: |
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1.1 |
Is the logbook/ records paginated and
issued by QA? |
All the activity shall be recorded in the
paginated logbooks and issued by QA |
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1.2 |
Is doer of the activity recording the
observation / parameter with sign/date and time (as applicable)? |
The documents shall be Attributable to
the person generating the data |
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1.3 |
Are the data entries being performed with
indelible ink (with color of ink as defined in SOP) and readable? |
Document shall be Legible and permanent. |
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1.4 |
Is any scribe used for making data entries? |
Should only take place where the act of
recording places the product or activity at risk and mentioned in SOPs. |
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1.5 |
Are the required entries in the log
books/batch documents/ Analytical sheets made on time and available? |
Document shall be Contemporaneous |
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1.6 |
Is the information/ data available in
original record or certified true copy? |
Document shall be Original |
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1.7 |
Is any editing to errors performed in
logbook/ document without documented amendment as per SOPs? |
The document shall be Accurate |
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1.8 |
Are logbooks/ documents has reference of unique
identification number as defined in SOPs? |
All documents shall have a unique
identification number (including the version number) and shall be checked, approved,
signed and dated (as applicable) |
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1.9 |
Is there any blank formats (including SOP
formats, Logbooks, note books, worksheets) found in area which is not issued
by the quality unit? |
All blank formats (including SOP formats,
Logbooks, worksheets, laboratory notebooks) shall be controlled by the
quality unit |
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1.10 |
Are logbooks/ documents has reference of format
no. as defined in SOPs? |
Documents should be stored in a manner which
ensures appropriate version control |
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1.11 |
Is soft copy Master document being
accessible at computers? |
Master copy (in soft copy) should be
prevented from unauthorized or inadvertent changes |
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1.12 |
Are there any obsolete format/ SOP/
document available or in computer? |
Updated versions shall be distributed in
a timely manner. |
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1.13 |
Is there any blank space left in filled
page of log book/ BPCR/ DRS etc. |
Entry of 'NA' placed in blank space (if required)
followed by sign / date. |
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1.14 |
Is there enough space provided in
logbooks/ BPCR/ DRS etc. in which the manual activities are recorded should
be ensured. |
Documents should be Contemporaneous |
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1.15 |
Is 24 hr (HH:MM) time format being used
in documents? |
Time format should be HH:MM (24-hour
format) |
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1.16 |
Are clocks/ timer designated in area
easily accessible to note the timings by doer? |
Clocks/ timer should be synchronized and
easily accessible. Documents should be Contemporaneous. |
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1.17 |
Are clocks/ timer designated in area
easily accessible to be changed/ modified by any person? |
Clocks/ timer should not be easily
accessible to be changed/ modified by user. |
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1.18 |
Is the correct unit of measurement is
used while recording: temperature/ weight etc.? |
Significant unit of measurement shall be
used as per requirement. |
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1.19 |
Are critical activities signed by doer
being checked by another person (wherever applicable)? |
Doer and checker provision shall be in
place for critical activities. Data should be Accurate and Original |
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1.20 |
Are print outs (e.g. autoclave, balance etc.)
duly signed by doer and checker and have cross reference to the original / mother
document? |
Records shall be checked, and cross
reference shall be available. Data should be Accurate |
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1.21 |
Are print outs which are on thermal paper
being photocopied prior to attachment? |
Thermal paper printouts shall be photocopied
and dully signed. Data should be Legible |
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1.22 |
Are the procedures of document review
available and followed? |
Data review procedures describing review of
relevant metadata should be available (as applicable) |
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1.23 |
Is archival of paper records not
performed by QA in secure and controlled archives? |
Archival of paper records by designated personnel
in secure and controlled archives |
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1.24 |
Is the observation being recorded as
visible in the display on instrument/equipment screen/ PLC/HMI etc.? |
Digits for data shall be visible from
equipment/instrument display. |
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1.25 |
Are entries in logbooks sequential, reliable,
complete and legible? |
Entries should be sequential, reliable,
complete and legible. |
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1.26 |
Is transcribed data verified against the
raw data for correctness and accuracy? |
Document should be original. If
transcribed cross reference of mother document shall be mentioned. |
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1.27 |
Is there any unauthorized changes
observed in the document? |
Unauthorized changes should not be done
in the documents |
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1.28 |
Is whitener/ opaque substance/ eraser / white
tape or whiteouts etc. used in document for correction? |
Data should be Legible (No usage of opaque substance) |
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1.29 |
Are corrections not initially signed with
date and properly justified? |
Corrections shall be justified with sign
and date. |
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1.30 |
Is there any partial correction of
numerical value? |
No partial correction of numerical value.
Data should be Legible |
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1.31 |
Does a signature log for employees available? |
The log should be available and maintained |
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2. Electronic Data: |
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2.1 |
Are individual Login ID and unique
password assigned to individual? |
Individual login ID should be assigned for
individual person. |
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2.2 |
Is user creation, authorization list available for the system defining access
levels? |
List shall be available for individual equipment and access levels should be
defined. |
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2.3 |
Does Audit trail contain following details, 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 |
Audit trial should contain the attributes |
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2.4 |
Does electronic data saved at the time of
the activity and before proceeding to the next step of the sequence of events? |
Data shall be saved at the time of
activity. Data should be Contemporaneous and Original |
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2.5 |
Is the audit trail secure and time-
stamped that independently record operator actions? |
Audit trail should be secured and time-stamped. |
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2.6 |
Is privileges given to any person to
overwrite the original data? |
Data should be Legible and access to
overwrite the data should be prohibited |
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2.7 |
Are electronic records archived by any
person in random manner? |
Archival of electronic records by designated
person in secure, controlled and reproducible electronic archives |
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2.8 |
Is there any provision available to
change time/date of system by doer/ checker? |
System should not allow to change the
time and date. |
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2.9 |
Is time/date of system synchronized
across the GXP operations? |
Time/date of system should be synchronized |
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2.10 |
Does audit trail reviewed in routine data
review/ approval process? |
Audit trial review procedure should be
available. |
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2.11 |
Does relevant meta data review along with
original electronic data? |
Relevant meta data shall be reviewed with
original data. |
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2.12 |
Is data review signified by electronically
signing the electronic data & metadata? |
As per approved procedure and system limitations
as validated. |
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2.13 |
Is computer system validated and
controls/ setting tested, locked and protected from unauthorized access? |
Validation should be available. |
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2.14 |
Does the system validation documentation include
established controls to ensure data integrity (data security- access
roles/permissions, sequence of operations, enabling of relevant audit trail)? |
Validation should be available. |
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2.15 |
Are the standards for the system’s
password strength and complexity defined and documented within system
documentation (requirements, and testing)? |
Computer system validation document should
be available with password complexity. |
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2.16 |
Is there a defined password expiration that
is enforced by the system? |
Password expiration should be enforced. |
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2.17 |
Is data retained in a non-editable format
or PDF format etc.? |
Approved procedure should be available for
back-up and storage |
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2.18 |
Are back-up copies of original electronic
records stored in another location as a safeguard in case of disaster? |
Approved procedure should be available for
back-up and storage |
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2.19 |
Are periodic tests performed to verify the
ability to retrieve archived electronic data from storage locations? |
Approved procedure should be available for
back-up and storage review |
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2.20 |
Is archival copy compared with the
original electronic data to confirm entire content and meaning of the
original record? |
Approved procedure for archival of data
should be available. |
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2.21 |
Are time/date and done by/ checked by printed
on records electronically? |
Records should be available in form of time
and date stamped records and signed. |
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2.22 |
Is authorization to verify data separate
from doer? |
Authorization to generate data shall be separate
to authorization to verify data |
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2.23 |
Is restoring of Back up data/Archiving Data
validated and regularly tested? |
Computer system validation shall demonstrate. |
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2.24 |
Does a list of computerized system available? |
The name, location and primary function
of each computerized system should be available. |
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2.25 |
A list of currently approved users,
specifying the users name and surname, and any specific usernames should be available. |
List shall be available for individual equipment. |
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2.26 |
System administrators should be
independent from users performing the task |
preferably IT personnel |
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2.27 |
Can general user switch off the audit trail? |
System should not allow to change the
settings |
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3. Personnel Training: |
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3.1 |
Is Training record for data integrity and
cGMP available? |
All personnel should be trained on data
integrity concept and cGMP |
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3.2 |
Is Training record available for related
SOPs as per job assigned? |
All personnel should be trained on
related SOPs as per job assigned |
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