Q：云系统如何合规？A：需确保云服务商能提供符合Part 11的服务协议，包括数据主权、审计支持等。Q：中国GMP与Part 11的关系？A：中国GMP附录《计算机化系统》与Part 11要求高度一致，可同步满足。CFR原文链接-英文版https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11?toc=1 往期IT小农工...
Part 11 Section 11.50a requires signed electronic records with the following data: name, date/time of signing, and meaning of signature. MasterControl provides fields for all required information to ensure FDA 21 CFR Part 11 compliance and for additional information if additional fields are desired...
LABELING SOFTWARE FOR FDA 21 CFR PART 11 Regulatory compliance through label management LABEL ARCHIVE for label Storage & security Multi-stage approval of label designs by reviewers Establish permissions to control access Keep record of changes, comments, revisions, and print history of every label ...
21 CFR Part 11 Compliant Comply with regulatory requirements when creating, storing, and managing GxP-regulated documents. Native support for audit trails, checksums for data integrity, and robust access control deliver a simple yet effective path to GxP and 21 CFR Part 11 compliance. ...
Arbour Group's experienced professionals are extensively trained in 21 CFR Part 11 Compliance, that determines the effectiveness of a client's process.
TEKLYNX CENTRAL CFR 是TEKLYNX專為幫助組織遵守FDA 21 CFR Part 11而設計的標籤管理解決方案。使用者能夠創建複雜的條碼,例如2D DataMatrix條碼、Health Industry Bar Code (HIBC)、GS1 Databar等。透過建立使用者權限並將電子簽名應用於標籤的整個生命週期,確保流程安全且合規。「...
■ Compliance with FDA 21 CFR Part 11 Using IRsolution The following components are required for compliance with FDA 21 CFR Part 11 when using a Shimadzu FTIR system: IRsolution Ver. 1.10 or later IRsolution Agent Ver. 2.11 or later (equipped with Agent Manager, User Authentication Tool, and ...
The Advanced CFR 21 Part 11 solution for Systec’s HX series of autoclaves optimises the digital documentation process based on the FDA CFR Part 11 regulations; this reduces hardware and software costs and ensures total compliance with international standards. The hardware and ...
FDA 21 CFR Part 11 clearly outlines a set of requirements for maintaining electronic records and getting electronic signatures. For regulatory affairs (RA) teams, it is important to maintain an exhaustive checklist to ensure regulatory compliance, even as regulations keep evolving. Over the years, ...
FDA CFR 21 Part 11 compliance and IEC 62394 compliance is achievable with Medical device development management solution from Polarion Software, which combines latest ALM technology with complete built-in standards knowledge base.