A L C O A

Attributable Sign, Date and Time must be required

Legible Data must be Readable

Contemporaneous Data must be recorded Online

Data must be recorded on Authorized

Original
Format

Accurate Data must be Actual

DATA INTEGRITY

DOs DON’Ts
Attributable

GMP DATA SHOULD BE RECOREDED WITH SIGN, NAME, DATE AND TIME
AT THE TIME OF ACTIVITY PERFORMED. THIS DATA SHOULD BE LEGIBLE

Batch Record

Legible Illegible Data checked

data before sign of
recording done by
 Attributable
DON’T DO SIGNATURE OF OTHER PERSON OR
DON’T RECORD THE GMP DATA ON BEHALF OF OTHER PERSON
TEMPERATURE LOG (Frequency : 30 + 5 minutes)

Person XYZ recorded entry ,

Sign/Date on behalf of ABC

Both person XYZ and ABC are Time of recording should be

recording entry exactly at half actual, as per defined
an hour, which is not possible. frequency and accurate.
Attributable
DON’T SHARE USER NAME AND PASSWORD TO ANY ONE.
USE INDIVIDUAL USER NAME AND PASSWORD ONLY.
DON’T USE GENERIC USERNAME/PASSWORD.

Tell me your
password

Sorry I cannot
share it with
anybody
Contemporaneous

DON’T PERFORM ACTIVITY IN BACK DATE

Back date signing done,

but doer was absent on that day
Contemporaneous

DATA SHOULD BE ONLINE RECORDED (CONTEMPORANEOUS)

Same person is participating

in two different activities at
the same time/date.
Original

DON’T RECORD GMP DATA ON UNAUTHORIZED PAPER

Recording on unauthorized paper,

Blank pages, back of envelops,
Excel / Word file in computer are
not acceptable
 Original

DO NOT TEAR THE GMP DATA RECORDED ON AUTHORISED PAPER- THIS

IS ORIGINAL DATA

Don’t Tear
GMP
documents
Original

AUTHORIZED FORMAT SHOULD BE USED FOR DATA RECORDING/

DON’T RECORD FALSE DATA

Authorized by signature and

date not available on the
used format.

Authorized Copy
Data doesn’t matched with
electronic data,
That means recording done
without performing the
activity
 Accurate

DO NOT RECORD DATA ON THE BEHALF OF OTHER EMPLOYEE

Person A : Performing activity

Person B: Reviewer

Recording should be Reviewer should be different person

done by Actual “DOER” who is not participating in activity but
only review each and every part of activity
Accurate

GMP DATA SHOULD BE ACCURATELY RECORDED IN WORKSHEET/BMR

Record the correct readings as

observed.
PH meter
Don’t manipulate the reading
7.10 to pass the batch
Display
A L C O A
Consistent Data must be in same format

Complete All data entry must be done

Data must be on authorized media

Enduring
with accountability

Documents must be available throughout

Available lifecycle for access and retrieve
 RECORD GMP DATA BY PERMENENT INK ONLY
DON’T USE PENCIL, ERASER, CORRECTION FLUID
LEGIBLE DOCUMENTATION

How you read this number?

1. 27
2. 24
3. 29

Always record the data

that can be easily
readable.
ORIGINAL DATA SHOULD BE RECORDED ACCURATELY ON AUTHORISED
FORMAT

Authorized format

Unauthorized format
RESULT FOUND OUT OF SPECIFICATION:
HOW TO RECORD AND WHAT TO DO ?

Don’t manipulate the

data for passing result .

Record as it is and go
through QMS tools to
address the same.
DOCUMENTATION PRACTICE

NA

Put Sign
and Date
WRONGLY RECORDED DATA HOW TO CORRECT

If any recording error

occurred, don’t
overwrite.

Don’t use fluid ink.

Use good
documentation practice
DOCUMENT SHOULD BE COMPLETE AND AVAILABLE

Document should be always

available for Audit/Review.

We never deny to auditor

for any document
IDENTIFICATION OF DUPLICATE DOCUMENT

Duplicity of any
document is easily
identifiable don’t make
duplicate document.
 GENERATION OF DATA

❖ Recording on paper, a paper-based record of a manual observation or

of an activity or
❖ electronically, using equipment that range from simple machines
through to complex highly configurable computerized systems or
❖ by using a hybrid system where both paper-based and electronic
records constitute the original record or
❖ by other means such as photography, imagery, chromatography plates,
etc.
 GENERATION OF DATA

Paper
Data generated manually on paper may require independent verification
if deemed necessary from the data integrity risk assessment or by
another requirement. Consideration should be given to risk-reducing
supervisory measures.
Electronic
The inherent risks to data integrity relating to equipment and
computerized systems may differ depending upon the degree to which
the system generating or using the data can be configured, and the
potential for manipulation of data during transfer between computerized
systems during the data lifecycle.
 GENERATION OF DATA

Paper
Data generated manually on paper may require independent verification
if deemed necessary from the data integrity risk assessment or by
another requirement. Consideration should be given to risk-reducing
supervisory measures.
Electronic
The inherent risks to data integrity relating to equipment and
computerized systems may differ depending upon the degree to which
the system generating or using the data can be configured, and the
potential for manipulation of data during transfer between computerized
systems during the data lifecycle.
 GENERATION OF DATA

❖ Raw data is defined as the original record (data) which can be

described as the first-capture of information, whether recorded on
paper or electronically. Information that is originally captured in a
dynamic state should remain available in that state.
❖ Raw data must permit full reconstruction of the activities. Where this
has been captured in a dynamic state and generated electronically,
paper copies cannot be considered as ‘raw data’.
 GENERATION OF DATA

Metadata

Metadata are data that describe the attributes of other data and provide context
and meaning. Typically, these are data that describe the structure, data elements,
inter-relationships and other characteristics of data e.g. audit trails. Metadata
also permit data to be attributable to an individual (or if automatically generated,
to the original data source).

Metadata form an integral part of the original record. Without the context
provided by metadata the data has no meaning.
 GENERATION OF DATA

Example (i) 3.5

metadata, giving context and meaning, (italic text) are:

sodium chloride batch 1234, 3.5mg. J Smith 01/Jul/14

Example (ii) 3.5

metadata, giving context and meaning, (italic text) are:

Trial subject A123, sample ref X789 taken 30/06/14 at 1456hrs.

3.5mg. Analyst: J Smith 01/Jul/14