Permeation Analyzers
Amatek Mocon - Software
Permeation Accessorie - Software
Overview:
ur software options simplify instrument management by centralizing data, and ensure data integrity for compliance requirements.
PermWare Software
21 CFR Part 11
IQ/OQ Documentation
PermWare – permeation laboratory management software
PermWare is the Master Data collection system for all MOCON permeation instruments. It is designed to simplify data handling and provide an overview dashboard for all Next Generation permeation analyzers.
Use PermWare to store, sort and manage all permeation test reports in one location. It provides a dashboard operations screen for all Next Gen instruments, on Windows 10 computers that allow a safe and secure connection to the instruments on the network.
Compliance software for FDA CFR 21 Part 11 (WinPerm 2)
21 CFR Part 11 contains FDA guidelines regarding electronic records for all FDA-regulated industries like drug makers, medical device manufacturers and biotech companies. Companies must implement controls, including audits and documentation, for software involved in processing relevant data.
MOCON’s Next Generation permeation instruments are each equipped with their own WinPerm2 system. Multi-level user controls allow users to operate with connection to a network for group management.
The software in MOCON’s Next Generation permeation analyzers allows simple compliance with FDA 21 CFR Part 11, including:
• Multi-level user management
• Audit trail
• Data security
• Data output
• Record retention
IQ/OQ
Healthcare and pharmaceutical customers rely on MOCON instruments to test packaging integrity for a variety of products. We provide instrument-specific IQ/OQ documentation that allows customers in these highly regulated industries to comply with federal regulations in a simpler, more streamlined process.
Purchasing AMETEK MOCON compliance documents gives you the benefits of:
• A trusted source for installation and operation qualification
• Easy-to-follow qualification steps
• 40+ years of experience working to help customers with compliance
• A vendor-supported source to create your own performance qualification documentation
