STANDARD OPERATING Doc No:

MEXE.QC.SOP.DI.001.00
PROCEDURE FOR DATA INTEGRITY

REVISION SECTION REASON FOR CHANGE DATE

NUMBER
00 ALL INITIAL RELEASE 16-01-2025

NAME DESIGNATION SIGNATURE

Prepared By SHARATH KUMAR G L QC ENGINEER

Reviewed and MANAGING

MAHESH JADHAV
Approved By DIRECTOR

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 STANDARD OPERATING Doc No:
MEXE.QC.SOP.DI.001.00
PROCEDURE FOR DATA INTEGRITY

1. INTRODUCTION
To establish a procedure for Data Integrity as per Good Documentation Practices (GDP)
2. SCOPE
The scope covers under this procedure to ensure that the Document handling properly without
any mistakes.
3. PURPOSE
The purpose of this procedure is to follow activities to carry out the Data Integrity as per Good
Documentation Practices (GDP)

All data entry on this document shall follow standard Good Documentation Practices (GDP).

 Recording of observation will follow good documentation practice.

 A ball point pen shall be used (Blue Ink).

 Correction fluid and other correction techniques that obscure the original entry should not be
used.

 Spelling mistakes and other changes shall be corrected as follows: Eg. Instalation, Installation
(initial & date).

 In the test data sheet test parameter and criteria will be pre-populated. Other cells e.g., observation
and signature will be completed by the person manually.

 When checking documents (text or drawing), a color code may be used:

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 STANDARD OPERATING Doc No:
MEXE.QC.SOP.DI.001.00
PROCEDURE FOR DATA INTEGRITY

 Green highlighting will indicate that the checked item complies with the drawing or the document.

 Pink highlighting will indicate that the checked item does not comply with the drawing or
document. The noncompliance must be recorded on the deviation List and must be resolved and
rechecked.

 Other coding conventions must be described on the documents.

 For each test or inspection, the appropriate column must be checked for compliance (PASS) or
noncompliance (FAIL) with the specification and/ or acceptance criteria. If it is not applicable
write NA.

 The column specified / recorded results will be used to document the numerical raw data, the
identification and the location of external document or any supporting comments. Upon
completion of each test or inspection, the person conducting the test will identify him / herself and
fill in the test date.

 Any deviation from the specification or the acceptance criteria must be filled in a deviation form &
also to be documented in the deviation list. A deviation must be understood as a failure to fully
comply with the acceptance criteria or specification. The deviation list item must be traceable to
the inspection or test that generated it. The description must be self-explanatory.

 The deviation list will clearly indicate whether the deviation is resolved or not.

 Sequence & numbering of deviation shall be filled as per following instructions:

Numbering of deviation should be sequential starting from “01” … “99”.

4. PROCEDURE:

 Data Integrity shall be maintained in all manual or system generated electronic data
 Data should be complete and accurate without any alteration
 Any identified data integrity issue shall be handled as per the quality management system and proper
corrective and preventive action shall be taken according to risk assessment
 Data generation and processing should follow the time sequence.
 Data shall follow the rules of ALCOA i.e. attributable, legible, contemporaneous, original and accurate.
Data should readable and complete
 Data shall be verified and approved by a competent technical person
 Data generation and recording or processing on behalf of another person shall be avoided
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 STANDARD OPERATING Doc No:
MEXE.QC.SOP.DI.001.00
PROCEDURE FOR DATA INTEGRITY

 All clocks used to record time data should be synchronized and controlled (time and date should not be
changed). Back date signature shall be avoided.
 All data should be traceable to its processing and modification.
 Action shall be taken on the generation of false data or modification of data.
 Data error found during the review shall be corrected with proper justification.
 Any paper or electronic data modification shall be attributable.
 Data can be excluded only after proper scientific justification and original data shall be stored for
traceability.
 Original data shall be stored as per the company policies and shall be destroyed with the reported data.
 Backup of data shall be taken periodically and the backup and recovery process shall be validated.
 Proper training on data integrity and usages of the computer systems shall be provided to all concerned
personnel.

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