This 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.

This project involved using Ignition in the personalized medicine industry to handle multiple communication protocols in one 21 CFR Part 11-compliant environment.

This 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.

The 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.

The 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).

Bachem 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

Snapdragon 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).

With deep experience in the Life Sciences industry, 4IR Solutions has developed a new cloud-hosted platform powered by Ignition, designed to meet the unique regulatory and compliance challenges faced by Life Science manufacturers, including Data Integrity and 21 CFR Part 11.

The 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.

Par 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. The project