Question

6. how can the integrity of the state be maintained? mention any three suggestion.
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Answer 1

Answer:

hi

Explanation:

these are some

1. Perform Risk-Based Validation

Validate only systems that are part of GxP-compliance. Ensure protocols address data quality and reliability.

In some cases it’s cost-effective to have the system vendor perform qualification and validation of the systems. To help decide between in-house or purchased validation service, use the ISPE’s GAMP5 (Good Automated Manufacturing Practice) categorizations to determine the validation complexity of your system.

Account for all electronic data storage locations, including printouts and PDF reports during validation.

Ensure your quality management system defines the frequency, roles and responsibilities in system validation.

Your validation master plan must outline the approach you will use to review meaningful metadata, including audit trails, etc.

Schedule periodic re-evaluations after your initial validation.

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2. Select Appropriate System and Service Providers

Ensure your providers are fluent with the relevant regulations.*

Systems must be fit-for-purpose. Get proof of a software’s efficacy for the application it will be used in.

Learn about your suppliers’ organizational culture and maturity relating to data management. Ask them what systems are in place to ensure data integrity and audit those systems if possible.

* See EU GMP EudraLex Annex 15: “Where validation protocols and other documentation are supplied by a third party providing validation services, appropriate personnel at the manufacturing site should confirm suitability and compliance with internal procedures before approval.”

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3. Audit your Audit Trails

An audit trail must be an inerasable record of all data in a system, including any changes that have been made to a database or file. To be useful in GxP compliance an audit trail must answer: Who? What? When? And Why?

Define the data relevant to GxP and ensure it’s included in an audit trail.

Assign roles and schedules for testing the audit trail functionality.

The depth of an audit trail review should be based on the complexity of the system and its intended use.

Understand what audit trails comprise: discrete event logs, history files, database queries, reports or other mechanisms that display events related to the system, electronic records or raw data contained within the record.