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- MINITAB EXPRESS AND MINITAB 18 COMPARISON SOFTWARE
- MINITAB EXPRESS AND MINITAB 18 COMPARISON PASSWORD
Both the current 21 CFR Part 11 document (the complete Code of Federal Regulations is revised annually) and the Guidance for Industry Part 11 document are available on the Minitab also welcomes feedback from customers that may help to direct future software development of our products. Minitab recommends that our customers contact the FDA for the most up-to-date information about Part 11 regulations. Providing audit trails and secure record keeping requires a system that satisfies all the components described by the Title 21 regulations, and specifically the Part 11 guideline. That is, the use of Minitab products alone does not make users compliant with this regulation. Just as our customers are responsible for validating their processes and systems that use Minitab products, they are also ultimately responsible for adhering to the guidelines for electronic record keeping and electronic signatures. The extent to which a regulated company satisfies the FDA requirements does not depend exclusively on whether Minitab software is compliant, but on how the regulated company uses Minitab products as tools in their research and their data analyses. In addition, Minitab Engage and Companion by Minitab include a data history that allows users to view the history of values stored in data fields of Workflow projects, including the value, the date it was modified, and who modified it. The snapshot can then serve as an archive, which can be stored alongside the actual tool and its current state. These products also provide a "snapshot" feature that allows users to take a static image of a specific tool at a specific time. This protection serves as validation for the ongoing use and storage of project files and data.
MINITAB EXPRESS AND MINITAB 18 COMPARISON PASSWORD
Minitab Engage, Companion by Minitab, and Minitab Workspace provide password protection for viewing, opening, saving, and modifying project files. Minitab Engage, Companion by Minitab and Minitab Workspace: The script and the output can be stored as part of a password-protected project file. Minitab Statistical Software also provides a scripting language that can be archived along with validated output. For complete control, password protection should be combined with a file or source control system to verify dates, times, and approved access. This protection serves as validation for the ongoing use and storage of Minitab project files. Minitab Statistical Software provides password protection for opening project files. We want to help our customers use our products in accordance with the guidelines of all regulatory agencies, including the FDA. Minitab® customers from industries regulated by the Food and Drug Administration (FDA) have asked about the compliance of Minitab software products with the FDA regulation on electronic records and electronic signatures (21 CFR Part 11). Minitab Products and Services and Compliance with CFR Title 21 – Part 11 - ID 2588
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For clarifying examples regarding software validation, visit the Minitab blog.