Strict environmental compliance in life science facilities isn’t an option – it’s the law. Federal regulations require pharmaceutical, biotech and medical device manufacturers to maintain not only close production tolerances, but critical facility reporting data as well.

Enacted in 1997, FDA 21 CFR Part 11 specifies stringent standards and procedures for electronic record generation, validation, storage, retrieval and protection. That’s why the building control system you choose must do more than maintain precise environmental conditions; it must capture and manage critical operating and procedural data with unchallenged accuracy.

WebCTRL for Life Sciences

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Secure thin-client architecture with FDA compliance

WebCTRL for Life Sciences, a secure thin-client building automation system built on open standards, has been installed in thousands of facilities across the globe. This system integrates powerful control technologies with FDA compliance criteria, providing electronic documentation capabilities. It also balances control access with the high level of security mandated by FDA regulations and your own corporate policies. It is easily deployed on your secure Intranet and accessed through any standard browser from any web-enabled device.

Complete, comprehensive and fully compliant control.

WebCTRL for Life Sciences complies with all technical and procedural reporting requirements of FDA 21 CFR Part 11. And it supports your compliance efforts with intuitive graphical programming - long considered the industry standard - that simplifies operation, minimizes disruption and risk and enhances productivity.

Advanced Security

To ensure data integrity, WebCTRL for Life Sciences addresses every aspect of data security so critical to FDA-regulated manufacturing. A dedicated server can be securely located within your facility; multi-use facilities can be supported with multiple, separate or hierarchical servers. Each of these server configurations can host a single, secure database (MS SQL, My SQL, PostgreSQL or Oracle) and use your existing Intranet.

Responding only to designated building automation protocols, WebCTRL servers employ Secure Sockets Layer (SSL) 128-bit encryption, BACnet whitelist firewall and advanced security password policies. These include username/password conventions that feature a specified number of characters, classes of character, rotating passwords, password cycles, etc. Inactivity logoffs and logon failures can also be documented and controlled.

Audit Trail

As required by FDA 21 CFR, WebCTRL for Life Sciences tracks and documents all procedural actions. Any attempted change to the environmental control system prompts user verification, including the electronic recording of “reason why”, in a secure audit log. To verify activity, system administrators can easily query the system’s database by operator, location or date.

Advanced Trending

With the WebCTRL system’s high speed architecture and distributed trending, all physical parameters – temperature, relative humidity, dewpoint, CFM and pressure – can be historically trended and securely stored. In addition, all environmental data, both current and historical, can be shown in tabular format or graphically displayed with a mouse click.

The frequency of trend sampling is controlled by the user. Operators can retrieve data by specifying month/day/year, and historical trend data can be exported “on the fly” with a mouse click. For additional data analysis, the WebCTRL system uses web services to interface with your enterprise software.

Fault Detection & Diagnostics and Advanced Alarming

Measures, anticipates, provides insight, and automatically responds to system conditions that are not necessarily critical, but may be trending that way – all with the goal of improved operational performance.

Accessed through any standard browser, the WebCTRL system’s advanced alarm reporting and archiving tool logs all authorized operators’ responses concerning alarm acknowledgement and follow-up action. Alarms can be routed to local printers, network printers, external databases, email addresses and SNMP traps simultaneously. Reporting data is securely stored on the WebCTRL system server for the time period specified by the system administrator.

An Abundance of Powerful, Standard Features

● Thermographic Color Floor Plans – convey a quick understanding of facility-wide comfort and operating conditions
● Logical Alarming – generates alarms and notifies users after specified events have occurred
● Trends and Scatter Plot Tools – enables operators to track and troubleshoot building conditions
● Time-lapse™ Graphics – rolls back time, up to a 24-hour slice, playing back hours of real-time data in just minutes
● Logging/Reporting – extracts and formats building data from a browser to Acrobat®, Excel® and other applications with a single click