1.0 PURPOSE:
This procedure ensures that all manual and electronic data generated during the GMP processes and implemented through the quality management system is complete, consistent, and accurate throughout the product lifecycle and in compliance with applicable regulations. This procedure emphasizes that everyone in the company is responsible for data integrity.
2.0 SCOPE:
The procedure includes reporting and investigation of breaches of data integrity and training and education of employees for ongoing compliance with the requirements of data integrity. This procedure applies to all manufacturing sites and Research and development centers of the Organization.
3.0 RESPONSIBILITY:
All Employees with GMP Responsibilities: Responsible for understanding and adhering to all the regulations and policies applicable to their role; signed acknowledgment of the policy as a condition of continued employment.
4.0 PROCEDURE:
4.1 Data Integrity: Generating, transforming, maintaining, and assuring the accuracy, completeness, and consistency of data over its entire life cycle in compliance with the applicable regulations.
4.2 Breach of Data Integrity: Acts of falsification, document adulteration, forgery and providing misleading information, intentional misrepresentation of data to hide known or potential problems.
4.3 Data: Information derived or obtained from Raw data (e.g., a reported analytical result). The data must meet the ALCOA requirements.
4.4 ALCOA: A commonly used acronym for ‘attributable, legible, contemporaneous, original and accurate’.
4.5 ALCOA-plus: A commonly used acronym for ‘attributable, legible, legible contemporaneous, original, and accurate which puts additional emphasis on attributes of being complete, consistent, enduring, and available-implicit basic of ALCOA principles.
4.6 Data Governance: The procedures to guarantee that data are recorded, processed, stored, and used to maintain the record throughout the data life cycle, regardless of the format in which they are generated. Throughout its existence, data must be available, consistent, full, and durable. This is ensured by data governance procedures.
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https://blogs.likeways.co.in/what-is-data-integrity-sop-for-data-integrity/
