Innovation from the IMC Group exceeds pharma’s new GDP & CAPA requirements

As a direct result of requests from pharmaceutical industry customers for humidity monitoring and calibration data recording to match the new GDP (good distribution practice) guidelines, IMC has introduced a range of key equipment that exceeds GDP guidelines.

IMC Group CEO Ian Robinson said: “Monitoring of environmental factors such as temperature and humidity is vital within the pharmaceutical industry, and The IMC Group’s Hanwell wireless monitoring stands out from the rest as a fully validatable system, offering monitoring for a wide range of parameters including CO2, light, UV, pressure and energy, as well as temperature and humidity.

The guidelines also require retention of calibration records; Hanwell transmitters retain calibration information and automatically run scheduled reports for calibration certificates showing which sensors received calibration and when. Total peace-of–mind! ”

Humidity and temperature control are now critical control points in many manufacturing processes. Yet the process of checking, recording and calibrating has often been a significantly manual process, soaking up hundreds of staff hours preparing and analysing large buckets of data.

Hanwell’s advanced wireless temperature monitoring and alarm solutions maintain optimum environments and product quality and save staff time by eradicating manual checks. Ideal for audits since monitoring and recording is automatic, eliminating human error.

IMC Group innovation is now enabling pharmaceutical industry clients to take all that critical environmental information and present it in a way that makes it as simple or as complex as they need it to be.

So while some require a system suited to a single user application, others need their data to be shared with multi-users such as internal colleagues via their own intranet, or with others via the web and from a single site to multiple locations around the world.

Simon Jacobson, research analyst for manufacturing operations at AMR Research is reported as saying that corrective and preventative actions (CAPA) problems can often be traced to the lack of consistent process requirements and written procedures, adding that the majority of companies only initiate their CAPA processes once a complaint or field failure is discovered.

IMC Group ‘Synergy’ is the software platform system to support all current and future Hanwell hardware. Synergy is a scalable browser-based database offering a contemporary management system that retains many of the underlying technical abilities of its well-known predecessor RadioLog8 but viewable in a more modern SQL format and provides significant additional user benefits.

Synergy is also an ideal response to GDP’s CAPA with extensive ‘alarm acknowledgement’ processes.

Innovative new platform

In every application the wireless technology innovation delivers the data customers need, when they need it, ready to view, share and interact; with live data and alarms from anywhere in the world at any time of day or night.

This new package is installed on a central server and can be quickly upgraded making it future proof, as well as cost and time efficient. Users can access and respond to live data, set up and amend user permissions, manage user groups and share information through their company network or on the internet. No matter what parameters organisations choose to monitor, Synergy offers an instant top-level overview of activity, 24/7.

There are interactive graphs and detailed reports on selected activities across timescales that are determined directly by the user. The comprehensive software provides full compliance data that meets MRHA and 21 CFR Part 11 regulations and collates all data for easy reporting and analysis. The system allows users to select immediate SMS (for out of hours) or email alarms to chosen personnel.