The LMS Pharma monitoring software system collects, displays and analyzes data for all phases of pharmaceutical operations. It provides automated and sophisticated alarm, notification, data viewing, reporting and auditing capabilities compliant with 21 CFR part 11.
Designed for high-reliability secure facility monitoring, LMS Pharma integrates robust and comprehensive security with system data redundancy and an intuitive easy-to-use interface. Real time and historical data can be securely viewed and analyzed in maps, trend charts (graphs), data tables, and fully customizable reports, with full alarm notification, acknowledgment and reporting capabilities.
Integral and powerful backup and redundancy support help maintain continuous operation. Its flexible architecture offers customization options and enables easy future expansion. Strong support for a wide range of industry standard platforms and protocols enable seamless integration with existing equipment, control systems, and IT environments.
All system components are designed for GMP, 21 CFR part 11 and GAMP compliance.
Features and Benefits:
- Easy-to-use intuitive User Interface
- Multi-level “drill-down” facility maps
- Real-time and historical data analysis via Trend Charts (graphs) and data tables
- Direct-action real-time dataviews provide point-and-click data viewing, analysis and response
- Open Architecture Integrates with External Systems via OPC, DDE, HTTP and others
- Designed for 21 CFR Part 11 Compliance
- Full alarm mangement and acknowlegment
- Alarm Notifi cation via alarm lights, e-mail and SMS
- Easy integration with Automation and Control systems and virtually seamless integration into existing IT infrastructure
- Integrated Industry standards include: OPC DA, OPC XDA, OPC HAD, OPC A&E, ODBC SQL and others
- Self publishing full featured thin client
- Customizable operation, which includes:
- Customize or create reports using Crystal Reports®
- Sophisticated scheduling and control capabilities
- Full language localization for operators and administrators
- Optional Batch / Lot recording and reporting module
- Secure database with robust system and data security
- Kiosk mode with secure production terminals
- Full audit trail with customizable views and reports
- Automatic data archiving and report exporting
- Calibration Mangement maintains Connected Instrument calibration information and warns or alarms for due or past-due calibrations
- Virtual Machine option for Hypervision installation
- Comprehensive backup, redundancy and failover:
- Automated data collection failover and failback
- Full redundancy backup of system confi guration and data
- View Client redundancy option allows remote viewing even if main server is offline
- Complete project life cycle documentation based on current GAMP and ASTM E 2500 guidelines
LMS Pharma Advanced Features:
Virtual Machine Distribution:
Integrates into existing Virtual Machine architectures.
Optional - system can be provided with up to three servers configured so that each monitors the other servers and all mirror the data.
Automatically generate reports per shift, day, week or month, for example. Send reports to e-mail, export to file, publish to intranet, etc.
Selectable Cleanroom States:
On-screen control to change cleanroom state from “In Operation” to “At Rest” or a custom state, as an example.
Dynamic Alarm Limits:
Change alarm limits and enable or disable sensors automatically based upon cleanroom state, time of day, day of week or other inputs. For
example, automatically change alarm limits when the cleanroom is changed from In Operation to at Rest state.
One way secure transfer of data through the company firewall to the public internet.
Pre-defined configuration parameters, executed on demand by an administrator. For example, change alarm limits based upon type of product or production methods.
Turn Pumps on and off, cycle pumps automatically, change cleanroom state based upon schedule or data conditions.
Buttons or other controls for pumps, Viable Sampling Impactors.
Custom Security Settings:
Restrict access to areas based upon user group permissions, add additional user groups.
System or Device Integration:
PLC drivers, import / export data from BAS or control systems, support for 3rd party notification packages.
Provides an Operator Terminal interface that blocks access to Windows functions, other programs and unauthorized system shut-down.