EU GMP Annex 11 - Overview
Available in Enterprise edition and will be enabled in your account on request
Zoho Sign now helps organizations and individuals in the life science industry, such as pharmaceutical manufacturers, medical device producers, medicinal products, medicine producers and distributors, to comply in accordance with the quality standards set out in Annex 11 of the European Union's Good Manufacturing Practice (GMP).
European Union Annexure 11 is a part of the EudraLex Volume 4 of Good Manufacturing Practice, which lays out the requirements to be followed by the life science industry to ensure the quality of the product, by outlining the requirements to use computerized systems in life science industries operating within the European Union.
EU Annex 11 contains the requirement for handling and authenticating the computerized systems, a combination of both hardware and software by addressing different areas such as validation, security protocols, audit trails, data storage, and the utilization of electronic signatures.
Need to comply with EU GMP Annex 11
EU Annex 11 outlines the criteria for validating, documenting, and maintaining computerized systems utilized in the production of medicinal products by setting strict rules for validating, documenting, and maintaining crucial production computer systems.
The main objective is to guarantee the dependability and precision of these systems, ensuring the manufactured products are reliable and accurate.
Validation: Computer systems must be validated to ensure the system's intended purpose is met.
Documentation: Precise documentation is crucial for all computerized systems, covering their design, creation, and functioning.
Maintenance: Perform maintenance on all computerized systems regularly to ensure they meet all the necessary requirements.
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