SOP For data integrity is described in this post which you can follow in the section of the Quality Assurance Department.

OBJECTIVE

To lay down a procedure for data integrity for documentation.

SCOPE

This procedure is applicable to all departments of the manufacturing facility.

RESPONSIBILITY

QA Officer

ACCOUNTABILITY

Manager Quality Assurance

Manager Quality Control

Manager Production

PROCEDURE

All the data either in manual form or electronic  must maintain its integrity

Data must be completed and accurate without any alteration.

Any issue in data integrity must be handled as per the quality management system (QMS) and proper corrective and preventive action (CAPA) must be taken according to risk assessment.

Action must be taken on the generation of false data or modification of data.

Data generation and processing must follow the time sequence.

Data must follow the rules of ALCOA i.e. 

  • Attributable
  • Legible 
  • Contemporaneous
  • Original 
  • And accurate

Data must be readable and complete.

Data must be verified and approved by a competent technical person.

Instruments having audit trial must be reviewed daily before approval of data and must be checked for any abnormalities.

Data generation and recording or processing on behalf of another person must be avoided.

All clocks used to record time data must be synchronized and controlled (time and date must not be changed).

Software's and computer systems used in data recording and processing must be validated.

Processed and computer-generated data must have the electronic signature of the user, reviewer and approver and signature must be secured.

All data must be traceable to its processing and modification. 

All original raw data must be stored.

For instruments those have only printed data output, print out must be considered as raw data and for the instruments store electronic data, the stored data files must be considered as raw data.

Data error found during the review must be corrected with proper justification.

Any paper or electronic data modification must be attributable.

Data can be excluded only after proper scientific justification and original data must be stored for traceability.

Reconciliation of issued documents like logbooks, protocols, batch manufacturing records, change control and deviation forms must be done wherever it is applicable.

System suitability data from instruments like HPLC and GC must be stored and documented.

Original data must be stored as per the company policies and must be destroyed with the reported data.

Unauthorized assess to the computer systems must be prevented by giving the assess rights as per the responsibility and role of the user.

User department must not have rights to alter the data files only IT person must have rights to alter and delete the data files.

Computer system users must not share their logins and must not access computer systems on behalf of others.

Backup of data must be taken periodically and the backup and recovery process must be validated.

Proper training on data integrity and usages of the computer systems must be provided to all concerned personnel