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Steering Committee Review: Data Integrity PPL – Ennore (August- 2023).
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Achievement Master Batch & Cleaning Record creation, review, approval & Issuance for batch in ‘Ensur’ implemented. Training assessment for SOPs implemented through ‘Ensur. Preparation, Review, Approval and Issuance of Analytical Testing Protocol (ATP) in ‘Ensur’ implemented. Over 90% of the Loose sheet formats converted to Bounded book. Additional controls established for remaining 10% loose formats which are used infrequently. Harmonized procedure implemented for User management access for GXP systems. Holistic assessment performed to determine the audit trail frequency for GxP systems based on existing controls..
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Thank You.