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9th January 2023 Content supplied by: Microgenetics
6 Considerations for Your New Environmental Monitoring System
How do you currently store and trend your viable environmental monitoring data?
Are you paying a full-time Microbiologist to sit and sift through reams of paper and set up Excel formulas so you can try to understand what your EM is telling you?
Or perhaps you use a dedicated environmental monitoring system but are due an upgrade to see beyond the usual patterns your data presents.
Either way, you are thinking about a change. Something that can be daunting in the pharmaceutical industry, given the time-consuming nature of validation and the need to balance Return on Investment (ROI) with tight regulations if you are going to make the switch.
What should you consider?
1. The problem you need solving
The obvious starting point: what problem is your lab facing?
- Do you need more in-depth data insights?
- Do you need to reduce costs, improve turnaround times and find a real-time solution?
- Are your QPs asking for visibility over your data?
- Do you need to automate a very manual, error-prone activity to meet data integrity requirements?
- Are your team stretched too thin over day-to-day tasks?
Once you’re aware of what issues you need to solve, you can start to think about:
2. The functionality of the system
You need to know what the system can do and if it meets your requirements:
What features and benefits does the software offer?
- Can it integrate with other systems (e.g. LIMS) or, even better, your batch release process?
- Which steps of the environmental monitoring process are covered (e.g. scheduling, incubation, reporting)?
- Is there any hardware? What footprint does it require? Can your lab accommodate this additional space need?
- Any technical requirements, such as internet connection in the lab, sufficient computers, data scanners, etc?
With an ever-changing regulatory horizon, compliance needs to be at the top of your priority list. Pharma companies are routinely slow to change, but regulators have little sympathy with this; how do you take existing systems and upgrade them in line with regulatory expectations?
The latest revision of Annex 1 places a greater emphasis on your contamination control strategy and environmental monitoring plan. You will need to consider how your results are generated and include trend analysis in your environmental monitoring plan to allow you to understand the source and root cause of contamination events. Is your current statistical analysis capability up to the challenge?
The use of historic data and scientific judgement will be central to this, so you will need to be able to draw out meaningful conclusions from an even bigger data set than before. It is worth asking these questions when looking at potential new environmental monitoring systems:
- Are the reports and graphs easy to understand by Subject Matter Experts and non-Microbiologists alike? Does it empower your Microbiologists?
- Do the reports guide your next steps in decision-making or simply give you data that is non-value adding?
- Is the storage reliable, so you can access historical data when required?
- Is accessing records easy (i.e., low likelihood of crashes or data loss)?
- Is it simple to graphically represent data?
- Is there any automation around identifying trends to take away the risk of error from human subjectivity?
- Is there a complete audit trail, so all changes to data are recorded?
- Can I meet ALCOA+ data integrity guidelines using this system?
4. Ease of getting started
Getting started is not always easy, whether you plan to build a new spreadsheet, create bespoke software, or use an off-the-shelf environmental monitoring system. Validating the system can be time-consuming, taking months or even, in some cases, years to get started. You will also need extra customer support during these implementation stages. Make sure you find out:
- Is it possible to validate the automated solution you have chosen, or will everything need to be double-checked?
- What does the implementation journey look like?
- Are OQ and IQ documents provided, or will your team have to carry out all testing?
- What level of customer support is available throughout onboarding?
- Is there the option to outsource validation?
When looking at an environmental monitoring system, you need to not just consider the arguably more important factors such as improved analysis capabilities, reduction of errors, data integrity, and improved mitigation decision-making steps. Whilst these elements ensure patient safety and the business's reputation, you will also need to consider the return on your investment.
- How many manual tasks (e.g., transcription stages) will this system remove?
- How many internal resources will the implementation process require?
- How does this system help me respond sooner to excursions (e.g., identify trends faster)?
- Will I save time on tasks like reporting?
- How much does the software cost, both upfront, for maintenance and upgrades?
Regulations may change, your business could scale up or down, and your database will keep growing as you add in more records. You will thank yourself for ensuring a system is futureproof before you invest.
- How easy is it to upgrade this environmental monitoring system, and how is the associated validation responsibility covered?
- How much do upgrades cost?
- How much data storage is available?
- How many users does the system allow (i.e., are there additional costs if the team grows)?
So, what’s out there?
Click here to read A Comparison of Microbiological Environmental Monitoring Systems for Pharma, or use the Request Information button below to contact the supplier.
Date Published: 9th January 2023
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