Annexure 11 2025

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The document is a Bond of Indemnity with Surety for obtaining duplicate unit certificates of face value Rs. 50,000 and above from the Unit Trust of India. It outlines the agreement between the applicant, the surety, and the Trust regarding the loss or destruction of original certificates, stipulating that the applicant has not dealt with these certificates and seeks duplicates. The agreement includes indemnification terms to protect the Trust against any losses incurred due to issuing duplicates.

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What is the Annex 11 regulation?

What is Annex 11? Annex 11 contains the EUs regulations for using electronic systems during clinical trials. It is part of the EudraLex, the Rules Governing Medicinal Products in the European Union. The European Commission creates and updates the EudraLex, which applies to sites, CROs and sponsors working in the EU.

What is the difference between 21 CFR and Annex 11?

Specifically, 21 CFR Part 11 governs electronic records and signatures in the FDA-regulated landscape and is more specific, while EU GMP Annex 11 guides computerized systems in the EUs GMP-regulated activities focusing on general guidance, effective implementation, and validation.

What is Annexure 11?

Annex 11 is a regulatory requirement for organizations that manage and store data using electronic systems. It lays out the principles and guidelines that organizations must adhere to in order to ensure the dependability, security, and integrity of electronic records and signatures.

What is the meaning of Annex 11?

EU Annex 11 requires all computerized systems to be validated and IT infrastructure to be qualified. This means verifying that a computerized system fulfills its intended purpose and operates as expected while ensuring that the IT infrastructure is capable of supporting the systems intended functions.

What is the annexure 11 in the pharmaceutical industry?

Annex 11 was created to ensure that when a computer is used in place of a manual operation in the manufacture of pharmaceuticals, there is no further risk to limb or paw when it comes to product quality, efficacy, or patent safety. While Annex 11 is not a legal requirement, it is a strongly recommended guideline..