SOP on Data Integrity in Pharmaceutical Industry


  1. Objective:

To lay down a procedure for data integrity as part of quality management system.

  1. Scope:

This procedure is applicable for all the data associated with GxP and quality management system.

  1. Responsibility:

All department involved in data generation, usage and retention. Senior management shall be accountable for the implementation of systems and procedures to minimise the potential risk to data integrity

  1. Procedure:

4.1 Data integrity is applicable for both manual recording (paper) and automated system (electronic).
4.2 Sufficient training shall be imparted to all concern personnel on data integrity.
4.3 Completeness, consistency and accuracy of data should be ensured.
4.4 Any data integrity identified shall be handled as per quality management system and risk assessment shall be performed wherever applicable. Appropriate corrective and       preventive action shall be taken.
4.5 Falsification of GxP records or data shall result in disciplinary actions.
4.6 The generation or processing of data shall follow a logical and sequential application of date and time.
4.7 Data shall be attributable (person generated or modified the data), legible (readable and permanent), contemporaneous (data recording at the time of activity), original (true copy) and accurate (error free). Additionally, data should be complete, consistent, enduring and  should be readily available and accessible throughout the life-cycle of data.
4.8 Data verification and approval shall be documented and shall include the review of raw data and metadata (metadata- data generated about data, e.g. audit trail).
4.9 Audit trail shall be reviewed as part of routine data review/approval process. Any       abnormalities identified during review shall be handled appropriately.
4.10 Data recording on behalf of others should be avoided and if unavoidable, appropriate justification (e.g. language/literacy limitations, documenting line interventions by sterile operators) shall be given with traceability of both persons performing the task and person completing the record.  All recording shall be contemporaneous.
4.11 Clocks for time recording should be controlled and synchronized. Time zones should be specified where data is used.
4.12 Data generated during maintenance or suitability testing activity shall be documented and retained.
4.13 There should be traceability of data reprocessing or modification i.e. traceability from final result to original raw data is required.
4.14 Equipment (e.g. pH meter, balances) that provides only printed data output, then print out shall constitute the raw data. Equipment that stores the data permanently and only holds certain volume, the data should be extracted as electronic data.
4.15 Errors or inconsistency identified during the data review, the reviewer must obtain clarification from the recorder and correction shall be made after appropriate       justification.
4.16 Any modification in electronic or paper-based data shall be attributable.
4.17 Data should be excluded based on valid scientific justification only. All data (even if excluded) shall be retained with original data set.
4.18 There shall be reconciliation of issued pages, worksheets, logbooks, notebooks and     printouts wherever applicable.
4.19 Original data shall be maintained as per document retention policy and shall be         destroyed as per policy.
4.20 Computer system and software for data processing shall be validated based on usage wherever applicable.
4.21 Electronic signature should be secured and it can be applied by the ‘owner’ of the     signature only. Electronic signature must provide traceability of signatory and date of   signature along with meaning of signature (e.g. reviewed or approved).
4.22 System users shall be given access as per their roles and responsibilities. User access rights shall prevent unauthorized data amendments.
4.23 Data migration/transfer shall be validated wherever applicable to ensure data integrity is maintained throughout the data life-cycle.
4.24 Any rights to alter the files and setting shall be given to personnel from independent department or different from user department.
4.25 Login should not be shared among individuals. If unavoidable, appropriate justification and documentation should be in place
4.26 Data backup should be performed routinely. Data backup and recovery process must be appropriately validated to avoid any alteration during backup and recovery process.
4.27 Records shall be retained in a manner that they can not be modified or deleted without traceability.
GxP: Common terms used for multiple practices defined by regulatory agencies (e.g. Good Manufacturing Practices, Good Laboratory Practices (GLP), Good Clinical Practices (GCP) etc.)
Complete: The data must be whole; a complete set
Consistent: The data must be self-consistent
Enduring: Durable; lasting throughout the data lifecycle
Audit Trial: An audit trail is a chronology of the “who, what, when, and why” of a record and exists in paper and/or electronic formats. The audit trail is a form of metadata containing information associated with actions that relate to the creation, modification or deletion of GXP records. An audit trail provides for secure recording of life-cycle details such as creation, additions, deletions or alterations of information in a record, either paper or electronic, without obscuring or overwriting the original record.
Data: Facts, figures and statistics collected together for reference or analysis.
True copy: A copy (electronic or paper based) of the original record that has been verified and approved.
Raw 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.
MHRA GXP Data Integrity Guidance and Definitions; Revision 1: March 2018
Guidance on good data and record management practices; World Health Organisation, WHO Technical Report Series, No.996, Annex 5; 2016.
Good Practices For Data Management And Integrity In Regulated GMP/GDP Environments – PIC/S; PI041-1(draft 2); August 2016.
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