STANDARD OPERATING PROCEDURE
Data Integrity
1.0 PURPOSE
To lay down a procedure for data integrity for documentation.
2.0 SCOPE
The scope of this standard operating procedure is applicable to all the department and activitY.
3.0 REFERENCES
NA
4.0 DEFINITIONS& ABBREVIATIONS
NA
5.0 RESPONSIBILITIES
Responsible Person Responsibilities
All Employees Responsible for implementation of this SOP
Quality Manager Ensure compliance of this SOP
6.0 GENERAL INFORMATION
Not applicable
7.0 PROCEDURE
7.1 Data Integrity shall be maintained in all manual or system generated electronic data .
7.2 Data should be complete and accurate without any alteration.
7.3 Any identified data integrity issue shall be handled as per the quality management
system and proper corrective and preventive action shall be taken.
7.4 Action shall be taken on the generation of false data or modification of data.
7.5 Data generation and processing should follow the time sequence.
STANDARD OPERATING PROCEDURE
Data Integrity
7.6 Data shall follow the rules of ALCOA i.e. attributable, legible, contemporaneous,
original and accurate.
a) Attributable
All data generated or collected must be attributable to the person generating the data.
This should include who performed an action and when. This can be recorded manually
by initialling and dating a paper record or by audit trail in an electronic system.
b) Legible
All data recorded must be legible (readable) and permanent. Ensuring records are
readable and permanent assists with its accessibility throughout the data lifecycle. This
includes the storage of human-readable metadata that may be recorded to support an
electronic record.
c) Contemporaneous
Contemporaneous means to record the result, measurement or data at the time the work
is performed. Date and time stamps should flow in order of execution for the data to be
credible. Data should never be back dated.
d) Original
Original data, sometimes referred to as source data or primary data, is the medium in
which the data point is recorded for the first time. This could be a database, an approved
protocol or form, or a dedicated notebook. It is important to understand where your
original data will be generated so that its content and meaning are preserved.
e) Accurate
For data and records to be accurate, they should be free from errors, complete, truthful
and reflective of the observation. Editing should not be performed without documenting
and annotating the amendments.
7.7 Data should readable and complete.
7.8 Data shall be verified and approved by a competent person.
7.9 Data generation and recording or processing on behalf of another person shall be
avoided.
7.10 All data should be traceable to its processing and modification. All original raw data
shall be stored.
7.11 For instruments those have only printed data output, print out shall be considered as
raw data and for the instruments store electronic data, the stored data files shall be
considered as raw data.
STANDARD OPERATING PROCEDURE
Data Integrity
7.12 Data error found during the review shall be corrected with proper justification.
7.13 Any paper or electronic data modification shall be attributable.
7.14 Data can be excluded only after proper scientific justification and original data shall be
stored for traceability.
7.15 Original data shall be stored as per the document control procedure.
7.16 Unauthorized access to the computer systems shall be prevented by giving the assess
rights as per the responsibility and role of the user.
7.17 Computer system users shall not share their logins and shall not access computer
systems on behalf of others.
8.0 ANNEXURE:
NA
9.0 CHANGE HISTORY
Date: Author: Version: Change:
