Key Notes on Revised Schedule M: Point No. 20 – Computerised systems

Last Updated on January 4, 2025 by The Health Master

Computerised systems

Key considerations for Point No. 20 –Computerised systems for compliance under revised Schedule M are outlined below.

Continued from: Key Notes on Revised Schedule M: Point No. 19 – Good practices in quality control

Good Manufacturing Practices (GMP) for Pharma Products with respect to computerized Systems

Pharma manufacturers must ensure that the computerised systems required for the maintaining the records as per the following provisions of the revised schedule M:

Validation:

• Validation of the computerised systems must be done to ensure that they are fit for their very purpose.
• The scope of validation must be ascertained by means of the complexity and criticality of the system.
• Qualification of the commercial software must be done which may require less validation process.
• Manufacturer may consider retrospective validation for their present systems, if suitable documentations are available in the facility.

Security and Control:

• Manufacturer must ensure the proper controls to prevent unauthorized access and changes the data of the system.
• A proper systems should be designed which can prevent deletion of data, which can be occurred due to failure of system or power failure.
• A record should be maintained regarding the data changes with respect to previous value, details of the person changes the data including the time and date of the said change.

Documentation and Procedures:

• Written procedures for the computerised systems must be prepared to establish the operation, change control and maintenance of the same.
• More checks should be implemented for the manual data entry of critical data e.g. second operator review, system based verification.
• Documents must be prepared and must be investigated regarding the Incidents which are affecting the quality of the product, record reliability and testing results.

Change Control:

• Any changes in computerised systems must be done as per the routine change control procedure and the same must be documented and tested.
• Records modifications and enhancements and other change controls must be maintained in the facility to ensure continued system validation.

Data protection and Backup:

• Manufacturer must have A backup system in the facility to prevent loss of data / records partly or permanently which may occur due to failure of the system or any other unforeseen situations.
• provisions for data protection must be in place to protect the information sensitive in nature.

• Recording of data:

• It is very necessary to record all the data in computerised system as well as non-computerised methods.

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Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana

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Next: Key Notes on Revised Schedule M: Tablets & Capsules (OSDF)

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