How do you store your environmental monitoring data? Perhaps you use paper and spreadsheets? Or maybe even a LIMS? If so, you probably find yourself frustrated with your current system throughout your EM process
That’s where using a dedicated EM software can help. Designed specifically for your environmental monitoring, solutions such as SmartControl EM have the tools you need to get more out of your data. Here’s how you could benefit by moving to such a system.
Do you use your original data for trending? Can you access what you need when you need it?
If not, you’re breaching ALCOA+. These leading data integrity guidelines have been adopted by regulatory bodies worldwide. Not meeting even one principle could lead to a lack of data integrity. If you can’t trust your EM data, can you make decisions from it?
SmartControl EM has been designed to help you meet ALCOA+. Referencing the above questions, using SmartControl EM, your data is entered directly into the system. Therefore, you’ll always use your original record for trending. As the software is cloud-based, this record is always instantly accessible to anyone who needs it.
Especially if you use paper and spreadsheets, there are probably plenty of steps in your EM process that add time but not value. For example, if you transcribe data from one source to another or spend hours creating complex schedules on a spreadsheet.
SmartControl EM streamlines your environmental monitoring process by minimising the amount of paper in your facility. In fact, compared to using paper-based systems and Excel, users of SmartControl EM are able to save up to 80% of an analysts time on EM related tasks, such as sample processing and reconciliation, graph generation and reports, and trending. Instead, you could focus on innovation, or perform second checks.
When it comes to scheduling, the easy-to-use scheduling tool will ensure no samples are missed or accidentally duplicated. An at-a-glance view of the number of samples scheduled, booked in or not yet received will be visible to both QC and monitors, for better planning and a more efficient use of resource across your team. Creating the schedule will take minutes rather than hours, and notifications when monitoring is missed means you can act immediately.
Do you struggle to meet regulation? Or perhaps find it challenging to keep up with the changes? GMP guidelines are expected to continue to encourage the adoption of technology throughout the pharmaceutical manufacturing process. For your EM, which is still very much a manual task if you rely on paper, it’s no different.
SmartControl EM has been built in line with GMP Annex 11 and 21 CFR Part 11, so you can be confident that you’re compliant. It will update hassle-free for no additional charge as regulation changes too, so you can feel certain that you’ll keep up.
Because manual environmental monitoring comprises of additional unnecessary steps throughout the process, getting to the point where you can trend your data takes time. It’s better to identify issues sooner rather than later, as delays could mean it takes time for you to react. Manual processes could also mean that excursions are too easily missed.
Using SmartControl EM, you’ll receive instant alerts of trends and limit breaches in your facility. In turn, you can act sooner. This should help minimise the number of excursions in your facility, whilst helping you to identify problem areas.
Many QC teams feel undervalued by their organisations. After all, it’s because of your hard work that you can be sure products are safe for patients, yet pressure for productivity is always increasing. Furthermore, being slow to respond to business needs, for example, when it comes to reporting, further strains internal relationships.
Boost the real and perceived value of your team with data that’s reliable, up to date, auditable and actionable. With SmartControl EM, you can easily create the reports you need, even setting them to recur. Gaining a deeper level of insight into your data will lead to better environmental monitoring decisions, in turn giving the business greater confidence in your team.