How an EMS Can Help ...
16th November 2022 Content supplied by: Microgenetics
Solving Your 5 Biggest Environmental Monitoring Challenges With SmartControl EM
What are the biggest challenges you face in your environmental monitoring facility?
We’ve spoken to plenty of Quality Professionals about what troubles them the most about their environmental monitoring. Usually, it fits within at least one of these themes:
- Meeting regulation
- Keeping track of samples
- Analysis & reporting
- Excessive paper
That’s where our environmental monitoring software, SmartControl EM, can help.
What is SmartControl EM?
SmartControl EM is a dedicated environmental monitoring software, designed to help Quality Professionals like you to meet regulation, whilst boosting productivity in pharmaceutical manufacturing facilities.
How confident are you that you meet regulation?
As regulations such as Annex 1 update, keeping up with changes has only become harder. Especially for facilities using paper, spreadsheets or other legacy systems that just weren’t built with these new regulations in mind.
With SmartControl EM, you will:
- Be using software built in line with FDA 21 CFR Part 11 and EU GMP Annex 11
- Stay ahead of future regulatory changes, including Annex 1, thanks to hassle-free updates to the software
- Meet ALCOA+ regulations, leading data integrity guidance used by regulatory bodies worldwide
Watch this video to learn more about how you can meet regulation with SmartControl EM.
Keeping track of samples
Especially if you use paper and spreadsheets for your EM, creating schedules and keeping track of your samples is probably a challenge. Not ideal, especially if you end up missing samples!
Use SmartControl EM to:
- Set up monitoring groups, so you can create clear schedules with ease
- Allow access to schedules for those who need it, improving communication with QC and within your team
- See an overview of the progress of samples through the QC process with SmartControl sample tracking, so you can be confident in the status of your environmental monitoring
See for yourself how SmartControl EM can improve your sample tracking and scheduling.
How long does it take you to trend your data?
Routine trending of your data provides confidence in the quality of manufacturing areas and the surrounding clean environments.
The sooner you identify trends, the sooner you can act. Yet for many facilities, there’s a delay between data transcription and trending.
- Data is entered directly into SmartControl EM from the start of the environmental monitoring process. This helps you reduce delays
- SmartControl EM instantly notifies you of trends, removing the need for an operator to look through all of your data
- Set your own trend "rules”, so you can define what your facility considers to be a trend
Make trending simpler with SmartControl EM – watch this video to see how
Analysis and reporting
How easy is it for you to create meaningful reports?
Analysis and trending using paper, spreadsheets and legacy systems share the same issues discussed above with trending. But with SmartControl EM, you’ll have:
- Built-in tools to automatically generate reports
- Reports can recur and you can set reminders
- Instant access to information about operators or locations needed for investigations
Watch to see how SmartControl EM gives you meaningful reports at your fingertips.
Using excessive paper for your environmental monitoring comes at a heavy cost to your data integrity. SmartControl EM will help you meet ALCOA+ by reducing your use of paper.
- Data entered directly into SmartControl EM means the original record is always used
- Risk of human error is reduced, with fewer transcription stages saving you time
- Cloud based, so data is easily accessible to an unlimited number of approved users, anywhere
- A complete audit trail records any changes made to original data, as well as information such as time, data and name of operator
- Powerful analysis tools using original data so you can have confidence that what you’re seeing is right
See how you can solve your data integrity challenges by minimising paper in your facility.
Whether you resonate with all of these challenges, or one in particular stands out, book your SmartControl EM demo today to see in more detail how it can help you. Click on the Request Information button below to contact the supplier.
Date Published: 16th November 2022
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How an EMS Can Help