SOP for Data Integrity : Pharmaceutical Guidelines

SOP for Data Integrity

Standard operating procedure for data integrity and error free documentation with their tractability to the original data generated by the computer systems.

1.0 OBJECTIVE

To lay down a procedure for data integrity for documentation.

2.0 SCOPE

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

3.0 RESPONSIBILITY

Chemist/ Officer/ Executive

4.0 ACCOUNTABILITY

All Department Heads/ QA Head

5.0 PROCEDURE

5.1 Data Integrity shall be maintained in all manual or system generated electronic data.
5.2 Data should be complete and accurate without any alteration.
5.3 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.
5.4 Action shall be taken on the generation of false data or modification of data.
5.5 Data generation and processing should follow the time sequence.
5.6 Data shall follow the rules of ALCOA i.e. attributable, legible, contemporaneous, original and accurate.
5.7 Data should readable and complete.
5.8 Data shall be verified and approved by a competent technical person.
5.9 Instruments having audit trial shall be reviewed daily before approval of data and shall be checked for any abnormalities.
5.10 Data generation and recording or processing on behalf of another person shall be avoided.
5.11 All clocks used to record time data should be synchronized and controlled (time and date should not be changed).
5.12 Softwares and computer systems used in data recording and processing should be validated.
5.13 Processed and computer-generated data must have the electronic signature of the user, reviewer and approver and signature must be secured.
5.14 All data should be traceable to its processing and modification. All original raw data shall be stored.
5.15 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.
5.16 Data error found during the review shall be corrected with proper justification.
5.17 Any paper or electronic data modification shall be attributable.
5.18 Data can be excluded only after proper scientific justification and original data shall be stored for traceability.
5.19 Reconciliation of issued documents like logbooks, protocols, batch manufacturing records, change control and deviation forms shall be done wherever it is applicable.
5.20 System suitability data from instruments like HPLC and GC shall be stored and documented.
5.21 Original data shall be stored as per the company policies and shall be destroyed with the reported data.
5.22 Unauthorized assess to the computer systems shall be prevented by giving the assess rights as per the responsibility and role of the user.

5.23 User department shall not have rights to alter the data files only IT person shall have rights to alter and delete the data files.
5.24 Computer system users shall not share their logins and shall not access computer systems on behalf of others.
5.25 Backup of data shall be taken periodically and the backup and recovery process shall be validated.
5.26 Proper training on data integrity and usages of the computer systems shall be provided to all concerned personnel

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure
6.2 IT: Information Technology
6.3 QA: Quality Assurance
6.4 HPLC: High Performance Liquid Chromatography
6.5 GC: Gas Chromatography

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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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