PerkinElmer Syngistix for ICP Enhanced Security for 21 CFR Part 11 Compliance

For pharmaceutical companies and their suppliers to be able to sell products into the United States, it is mandatory to comply with 21 CFR Part 11 regulations, which include criteria around electronic records, electronic signatures, and audit trails to ensure data integrity and reliability during the analytical testing. If your laboratory needs to test for elemental impurities in pharmaceutical products, trust PerkinElmer to provide the software functionality to fully meet these technical requirements. Introducing the NEW Syngistix™ for ICP Enhanced Security™ software version 4.0 for PerkinElmer ICP instruments, with key security features including:

• Secure audit trail
• Electronic signatures and records
• Data integrity
• Password-protected database file structure
• Login history
• Configurable password control

Not only does the software provide the required functionality to aid in compliance with 21 CFR Part 11, it does so simply:

1. 1. Administrators define users & groups, set up permissions, electronic signatures, and security settings – and much more under User Setup, a simple but powerful app outside of the main Syngistix operating environment.
2. 2.一旦设置好用户权限和电子签名参数，并准备好样本，操作人员就可以在管理员在用户设置中定义的限制范围内进行分析，确保可追溯性和数据完整性。当示例运行时，很容易在Users之间切换，例如，Reviewer可以审阅以前运行的示例，而不必等待当前的示例集完成。如果您不想让任何人在分析过程中接触软件，那么只需简单地点击一下就可以锁定该软件。
3. 3. After an analysis is complete, the data can be quickly reviewed and approved/rejected through ES Tools. This dashboard interface lets you quickly and easily review data, methods, the audit trail, event logs, and file changes. With the ability to filter, sort, and compare entries, it’s easy to find what you’re looking for. Reviewing, approving, rejecting, and adding comments are just a click away, along with the ability to export and print individual samples and batches in a human readable format.

Syngistix for ICP Enhanced Security software version 4.0 provides regulated laboratories powerful but simple-to-use tools to meet the technical requirements for 21 CFR Part 11 compliance, offering flexibility while providing electronic signature points, maintaining data integrity through a database file structure, and implementing a secure audit trail.

Learn more关于Syngistix的ICP增强安全软件的新功能-下载我们的产品和应用资源。