InduSoft Web Studio is a SCADA software platform that has been used for applications designed to meet international standards, such as FDA 21 CFR Part 11, EU Annex 11, GAMP, and more. Any application that must adhere to standards of government or industry regulation requires tools and functionality for traceability and data verification in the SCADA software it’s built. InduSoft Web Studio has proven through multiple applications and several top-level audits in multiple industries that it possesses the tools necessary for tracking, traceability, batch and recipe reporting, and data verification.
FDA 21 CFR Part 11, EU Annex 11, and GAMP Compliance
Functionality such as security, e-signatures and traceability, batch reporting and automatic writing to any SQL database are some of the tools which can be employed to maintain a fully compliant process that will meet international standards for food and drug and pharmaceutical manufacturing. InduSoft Web Studio possesses all the tools required to make a project that adheres to FDA 21 CFR Part 11, EU Annex 11 and GAMP (Good Automated Manufacturing Practice) guidelines. The ability to store and record data for each batch makes it easy for representatives of the FDA and EU Annex, and other regulatory bodies to audit and verify data.
For more information on how InduSoft has helped industries adhere to the regulations that govern them, please see the following case studies: