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31st January 2023  Content supplied by: Microgenetics

How an EMS Can Help You Meet Annex 1

With the new Annex 1 set to roll out in August, are you thinking about how you can improve your environmental monitoring plan?

After all, this vital part of your contamination control strategy has a greater prominence in this revision than ever before in EudraLex. Considering if your current processes are complaint – not just the monitoring itself, but also your data recording and analysis– will be necessary over the coming months.

This will especially be the case if you are still using paper and spreadsheets in your facility.

Environmental monitoring teams process vast amounts of information, which can make data-driven decision-making challenging. It’s too easy to miss trends, too hard to create graphical representations of your data, and there are significant data integrity issues to this approach. Even an overloaded access database or LIMS will experience these same issues.

Sounds familiar? If so, you should consider an EMS.

What is an EMS?
An EMS is a software solution to help you store and analyse your environmental monitoring data in a compliant manner. It will help you to overcome challenges such as delays in accessing the data you need, minimise the risk of data loss and help you get more out of your data at the click of a button. Another benefit of an EMS is that it is designed specifically for your monitoring, unlike LIMS, which are often designed with QC Chemistry in mind, or spreadsheets.

How will an EMS help you meet Annex 1?
Your environmental monitoring plan will need to consider how your results are generated and include trend analysis to allow you to understand the source and root cause of any contamination. The use of historical data and scientific judgement to make decisions will be key to doing this – which means more data.

How can your EMS help with this?
Secure data storage: reduce the risk of data loss or accidental manipulation, so you can trust the accuracy of new and historical records

Have all your data in one place: easily accessible with no need to re-transcribe or move data. Also, you can look at multiple data types concurrently – something specifically mentioned in the Annex regarding viable and total particle levels.

Meaningful visualisations of data in minutes: perform in-depth analysis of your data hassle-free, boosting your productivity whilst enabling you to take better environmental monitoring decisions sooner

Trend all your data: whilst isolated limit breaches may not mean a loss of control, having no limit breaches may not mean good control either. Your EMS will help you trend all your data, such as samples taken nearby, to help you better understand your facility.

What is SmartControl EM?
SmartControl EM is a dedicated environmental monitoring software designed by Microbiologists for Microbiologists. It will help you meet regulation, even updating in line with any changes so you can be certain of staying ahead.

SmartControl EM will also streamline your monitoring process; in fact, from scheduling samples through to reporting, you can save up to 90% time compared to spreadsheets.

When you enter your data into SmartControl EM, it’s saved to the cloud. Any changes to your data will also be recorded as part of a complete audit trail – required by Annex 1. These records are instantly accessible to an unlimited number of approved users from anywhere. Moreover, cloud-based storage has enhanced security, so the chances of data loss is minimal.

As well as simple data entry, you will also benefit from easy-to-understand reporting and analysis tools. One of the changes with the new Annex 1 is around organisms that indicate loss of control (previously called objectionable organisms). You not only have to identify all organisms in Grade A and B environments but also periodically look at isolates from Grade C and D areas to give an idea of normal flora and identify any changes. SmartControl EM allows for easy analysis of this kind of data.

When it comes to trending, SmartControl EM is always looking at your data. You can be sure to never miss a trend or limit breach again as you’ll be instantly notified through the software and via email notification. This also reduces delays in investigations, helping you to minimise any issues when they do occur.

SmartControl EM comes with pre-prepared plans and tools, so you can leverage central testing such as IQ and OQ tests and validation by Microgenetics. This saves significant set-up time, so you can have the software in your facility faster than it will take you to adapt your current spreadsheet or LIMS to the coming Annex 1 changes. In fact, SmartControl EM could be up and running in your facility in just six weeks.

Why not get the ball rolling today and download a brochure to find out more, or use the Request Information button to connect directly with the supplier.



Date Published: 31st January 2023

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