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Open Daily: 10am - 10pm | Alley-side Pickup: 10am - 7pm
3038 Hennepin Ave Minneapolis, MN
612-822-4611
Software Development for GxP Regulated Industries: Deliver GxP Compliance Software in an Agile Way

Software Development for GxP Regulated Industries: Deliver GxP Compliance Software in an Agile Way

Paperback

Programming

ISBN13: 9798282856330
Publisher: Independently Published
Published: May 7 2025
Pages: 34
Weight: 0.13
Height: 0.07 Width: 6.00 Depth: 9.00
Language: English
Software development for GxP-regulated companies involves additional requirements, including specific guidelines from EU Annex 11, and FDA CFR Part 11. These requirements cover aspects such as electronic signatures, audit trails, data integrity, and more. Due to the stringent regulations governing GxP-regulated companies, software and system suppliers must adhere to established rules and procedures for developing, releasing, implementing, and maintaining software.

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