Source: https://allurent.com/products/accusign-21cfr-part-11/
Timestamp: 2018-04-25 20:16:36
Document Index: 610614994

Matched Legal Cases: ['art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11']

21 CFR Part 11 (ACCUSign) - Allurent Corp
ACCUSign (21CFR Part 11)
ACCUSign – 21 CFR Part 11 Compliance Tools
Protect manufacturing data to secure the management of process information
A key feature of the VANGUARD MDATM suite of tools and applications is a rich manufacturing data model built in Microsoft’s SQL Server Relational Database Management System (RDBMS).
The VANGUARD Data Model, built specifically for use in 21CFR Part 11-goverened manufacturing environments, provides a secure data repository capable of supporting many feature-rich manufacturing data applications and reports.
21CFR Part 11 mandates that electronic manufacturing data is secure and that records containing information about individual users are obtained using secure Electronic Signatures. ACCUSign 21CFR Part 11 Compliance Tools, the Electronic Signature portion of VANGUARD MDA, provides that high level of required security.
ACCUSign 21CFR Part 11 Compliance Tools will securely authenticate user actions while also maintaining a complete log (audit trail) of all user actions. Through ACCUSign, users can be notified of incorrect password entry, allow password changes, provide desktop locking of workstations based on security group permissions, prevent unauthorized access to plant applications, and more.
Key features and applications of ACCUSign 21CFR Part 11 Compliance Tools include:
ACCUStep Recipe Management System
The ACCUStep Recipe Management System provides a robust way to store manufacturing process steps and parameter values in VANGUARD’s relational data model. Recipe Authors can easily create and modify recipes while operators download the recipes to the manufacturing control system.
This feature allows manufacturing products to be stored in the automated process system, each containing a different set of instructions and process values.
Storing these recipes in a relational manufacturing database provides a practically unlimited amount of space in which to store recipes and is far superior to storing them in the controllers themselves. By integrating with ACCUSign, an audit trail is automatically created of all changes and all recipe modifications can be protected with Electronic Signatures.
ACCUTrend Data Visualization Tool
The ACCUTrend Data Visualization Tool is a powerful application for presenting various types of manufacturing process data collected into the relational database or process historians.
Designed to be integrated directly into the manufacturing process, ACCUTrend is capable of accessing data from multiple automated manufacturing data sources and combining them in a meaningful way.
By layering manufacturing data from multiple data sources, ACCUTrend provides the end-user with a broader understanding of the manufacturing data to make decisions faster and more efficiently.
ACCUReports Manufacturing Reporting Tool
The ACCUReports Manufacturing Reporting Tool is a front-end wrapper for Seagate’s Crystal Reports application. While Crystal Reports is a powerful data reporting tool, it is not designed specifically for manufacturing although it is highly effective with analyzing data presented throughout the manufacturing process.
ACCUReports adds useful data report retrieval services to access manufacturing reports by Batches, Date Ranges, specific manufacturing processes, and more.
ACCUReports is also an ActiveX COM application that allows for seamless integration directly into the manufacturing front-end systems. Simply create manufacturing data analytics reports using the Crystal Reports Application and use ACCUReports to display them.
Allurént’s ACCUSign 21CFR Part 11 Compliance Tools within the VANGUARD MDATM suite provide the high level of security required in the secure management and processing of your manufacturing data. Contact the Allurént team to discover how ACCUSign will protect your automated manufacturing platform.