Software for Pharma, Food & Beverages
ICONICS’ suite of applications offers features and functions specifically designed to aid in complying with the FDA 21 CFR Part 11 regulations that are now sweeping the globe.
Benefits
•Maximum security with integrated popular biometrics
•Operational accountability through sequence checking
•Accurate audit trail information of who did what, when, where, and why
•Applications that are designed for the FDA 21 CFR Part 11 regulation
Regulatory and Compliance Software for the Pharmaceutical Industry
•Designed for 21 CFR Part 11 e-Signature Compliancy
•Secure Audit Trails Track Operator Control Changes
•Security Server Enforces Logins and Restricts Access
•One Software System Reduces Development Time
•Record and Report Operator Comments
•Scalable Data Logging to Secure Standard Databases
•Create Operational Sequence Checking for Operators
•Configuration and Runtime Password Revision, Control and More
•Integrated Security Restricts Access with Biometric Technology
•International Language Switching Technology
•Traceable Alarm and Event History
Product Features
Production Quality
Manage pharmaceutical production quality with native graphs and trends, as well as a native quality reporting product, Quality AnalytiX®. Quality AnalytiX enables operators, quality personnel, manufacturing engineers, and management to view quality SPC data and other production parameters impacting product quality.
Reporting
As a fully integrated reporting module, ReportWorX™64 pushes data into report spreadsheets using the power of Microsoft Excel. Its advanced scheduling engine can deliver reports directly to your mailbox or phone, or on demand from an HMI screen, so your data is always there when and where you need it.
FDA Compliance
ICONICS solutions are fully compliant with FDA Title 21 CFR Part 11, ensuring that electronic records and signatures mandated by the FDA are respected.
Recipes
Create and save recipes to quickly initiate pharmaceutical production with the ICONICS native recipe management module. Use recipes to monitor material needs and calculate costs of products and batches.
GENESIS64™ FDA 21CFR11 Capabilities
This paper provides useful info on features of several GENESIS64™ components that may be useful to companies wishing to comply with FDA 21 CFR Part 11.
Recipe Management System
This paper outlines the ICONICS Recipe Management System by providing examples that illustrate the capabilities of this tool in ICONICS GENESIS32™, which can be used to manage and control real-time processes.