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https://www.inductiveautomation.com/resources/article/21-cfr-part-11-and-pharmaceutical-best-practices-with-ignitionThis guide addresses Food and Drug Administration (FDA) 21 CFR Part 11, Data Integrity and Good Automated Manufacturing Practices (GAMP). It provides best practices and guidelines supporting regulated Ignition applications in the life sciences and pharmaceutical industries.
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https://www.inductiveautomation.com/resources/casestudy/pharma-company-meets-standards-for-21-cfr-11-with-ignitionThe FDA’s Title 21 of the Code of Federal Regulations Part 11 — also known as 21 CFR 11 — establishes rules for the use of electronic records and signatures, covering authentication, confidentiality, integrity, availability, and more.
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https://www.inductiveautomation.com/resources/customerproject/variety-of-connections-and-unlimited-licensing-aid-cancer-therapyThis project involved using Ignition in the personalized medicine industry to handle multiple communication protocols in one 21 CFR Part 11-compliant environment.
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https://www.inductiveautomation.com/resources/casestudy/helping-customers-with-21-cfr-part-11Snapdragon recently adopted Ignition for supervisory control and data acquisition (SCADA), and is leveraging that system to help its customers comply with requirements from the United States Food & Drug Administration (FDA).
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https://www.inductiveautomation.com/blog/facing-21-cfr-part-11-and-data-integrity-requirements-with-confidenceThis has been driven by 21 CFR Part 11 and ALCOA standards, which are in place to help ensure the quality and safety of all pharmaceutical products.
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https://www.inductiveautomation.com/resources/icc/2023/sepasoft-mes-orchestration-for-digital-transformationThe correct tasks must be carried out in the correct order, with the correct materials, approvals, quality checks, and accurate records, especially in regulated industries (e.g., 21 CFR Part 11).
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https://www.inductiveautomation.com/resources/article/21-cfr-part-11-compliance-with-inductive-automations-ignition-platformThe Ignition platform can be configured to be Part 11-compliant, ensuring data integrity through implementation of ALCOA+ concepts. This white paper will discuss the various components of Ignition that allow for Part 11 compliance and implementation of data integrity principles.
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https://www.inductiveautomation.com/resources/customerproject/improved-data-integrity-and-easier-compliance-with-21-cfr-part-11Par Pharmaceutical worked with Grantek as part of Par’s corporate data integrity initiative to improve production data quality and regulatory compliance. The project related to fluid beds, which are pieces of equipment used to reduce the moisture content of pharmaceutical powder and granules.
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https://www.inductiveautomation.com/blog/native-electronic-signature-support-a-breakthrough-for-21-cfr-part-11-complianceThe newly released Ignition 8.1.16 introduces native support for collecting electronic signatures with Ignition Perspective applications. This is more than a convenient upgrade; it’s a significant achievement, especially for Life Sciences customers, where electronic signatures are often subject to strict
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https://www.inductiveautomation.com/resources/customerproject/meeting-21cfr-11-standards-for-pharmaBachem Americas, a pharmaceutical company, designed and built a new cleavage unit for its chemical process at its Vista, Calif. facility. Inductive Automation’s Ignition software was used as a uniform HMI for the cleavage unit control system to provide fast and reliable access for monitoring data and
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