SOP for Data Integrity

OBJECTIVE

The objective of this SOP is to define a procedure to access, review, monitor, and ensure the Data Integrity of the entire data generated, to apply a robust system that inhibits data risk, to improve the detection of data reliability, and to address the root causes when failure is observed.

SCOPE

This SOP is applicable to all types of data generated in the form of paper or electronic data across all the functions of PharmaInfo Ltd., throughout the data life cycle.

RESPONSIBILITY

• All employees are to follow the procedure for data security and integrity.
• All HODs are to comply with the SOP for data security and integrity.
• QA department shall conduct the periodic review of data handling in accordance with the SOP.

DEFINITIONS

Data: The information derived or obtained from raw data and generated as paper-based or electronic records is called data.

Raw Data: Original records, documentation, and printed data output, retained in the format in which they were initially generated (i.e. paper or electronic).

Meta Data: Metadata is the contextual information required to understand data. A data value is by itself meaningless without additional information about the data. Metadata is often described as data about data.

Data Security and Integrity: Refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data shall be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).

ALSO READ: What is Data Integrity and Why is it so Important?

Audit Trial: a secure, computer-generated, time-stamped electronic record that allows for reconstruction of the course of events relating to the creation, modification, or deletion of an electronic record. An audit trail is a chronology of the “who, what, when, and why” of a record.

Back-up: refers to a true copy of the original data that is maintained securely throughout the records retention period for recovery. The backup file shall contain the data (which includes associated metadata) and shall be in the original format or in a format compatible with the original format.

Data Life Cycle: All phases in the life of the data (including raw data) from initial generation and recording through processing (including transformation or migration), use, data retention, archive/retrieval, and destruction.

Attributable: Data record linked to the name of a person or the source from where data was acquired, who performed any action on or with the data.

Legible: Paper-based data shall be in handwriting that is decipherable or readable.

Contemporaneous: Data shall be recorded at the time of data capture or when work is performed and the date/time shall follow in order. The evidence of actions, events, or decisions shall be recorded as they take place.

Original: Data shall be recorded on the original sheet or the database/table. Also signifies the importance of maintaining raw data and metadata. The original record can be described as the first capture of information whether recorded on paper or electronically.

Accurate: The data contains the correct value. Accurate data not only adheres to integrity constraints and measurement rules but is data that reflects actuality.

GxP: GxP stands for Good X Practices (X can mean: Clinical, Laboratory, Manufacturing, Pharmaceutical, etc.)

Documentation: Documentation provides objective evidence of compliance. It is recorded information, written or electronic, used to establish specifications, processes, direct work, and collect records that ensure compliance with Quality systems. A well-prepared document must be permanent, legible, accurate, consistent, clear, and truthful.

FLOW CHART

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.

ALSO READ: Data Integrity Checklist for Pharmaceutical Industry

• The action shall be taken on the generation of false data or modification of data.
• 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 be readable and complete.
• Data shall be verified and approved by a competent technical person.
• Instruments having audit trials shall be reviewed daily before approval of data and shall be checked for any abnormalities.
• Data generation and recording or processing on behalf of another person shall be avoided.
• All clocks used to record time data should be synchronized and controlled (time and date should not be changed).
• Software and computer systems used in data recording and processing should be validated.
• Processed and computer-generated data must have the electronic signature of the user, reviewer, and approver and the signature must be secured.
• All data should be traceable to its processing and modification. All original raw data shall be stored.
• For instruments that have only printed data output, print out shall be considered as raw data, and for the instruments that store electronic data, the stored data files shall be considered as raw data.
• Data errors 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.
• Reconciliation of issued documents like logbooks, protocols, batch manufacturing records, change control, and deviation forms shall be done wherever it is applicable.
• System suitability data from instruments like HPLC and GC shall be stored and documented.

• Original data shall be stored per the company policies and destroyed with the reported data.
• Unauthorized access to the computer systems shall be prevented by giving the assess rights as per the responsibility and role of the user.
• The user department shall not have the rights to alter the data files only the IT person shall have the rights to alter and delete the data files.
• Computer system users shall not share their logins and shall not access computer systems on behalf of others.
• Backup of data shall be taken periodically and the backup and recovery process shall be validated.
• Proper training on data integrity and usage of the computer systems shall be provided to all concerned personnel

ABBREVIATIONS

SOP: Standard Operating Procedure

IT: Information Technology

QA: Quality Assurance

HPLC: High-Performance Liquid Chromatography

GC: Gas Chromatograph

ANNEXURE

Nil

REVISION HISTORY

Nil

ALSO READ: SOP for Change Control in Pharmaceuticals