GMP Environmental Monitoring

Your environmental monitoring processes streamlined. 

Patient safety is critical. Therefore, in GMP, the manufacturing process of pharmaceutical products happens under strictly-controlled environmental conditions as potential contamination might have dramatic consequences. 
MyCellHub helps you streamline, optimise and automate your environmental monitoring with cutting-edge digital tools to cut costs and save a great deal of time! Discover how MyCellHub helps digitalise environmental monitoring in your cleanroom.

Plan. Assign. Schedule. Track.

Easily create sampling processes from existing templates with well-designed work instructions.

Effortlessly assign workflows to operators and plan sampling executions via a master plan.

Track process execution in real-time and remotely.

Interactive work instructions. Smart data collection.

Capturing GMP data has never been so easy!

Save time and avoid errors by visualising your facilities in a blink and defining exactly where sampling plates should be located.

Work instructions are interactive and standardised. From tables and dropdown menus to images, tick boxes or free text, choose from many instruction options displayed in a very user-friendly way.

Built-in barcode scanning.

Save endless hours of transcription work!

Use the tablet’s camera to scan your plates’ barcodes in a snapshot. Each sampling plate ID is then automatically created and importing into the database. 

No need to worry about reconciliation of samples and results anymore. All test results can easily be retrieved from external sources and linked to their respective plates.

Simple report review. From anywhere.

Review reports wherever you need, whenever you need. 

Generate sampling plan for your cleanroom and process reports in a simple click, at any given time. 

Access, review and approve reports remotely, in a fully digital and convenient way. 

Secure data centralisation.

All the data you collect and generate is centralised, safely stored, automatically backed-up and well-organised. Filter data as needed, export and access it at any time.

Quickly perform reviews by exception at a glance, based on custom alert and alarm limits. GMP compliance has never been so easy!

Automated trending and analytics.

Reports, whenever and however you need them.

Save hours of manual report creation by making use of the tailor-made reporting templates in a simple click.

Generate trend reports for a single room – or as many rooms as you need across your facilities. Annually, quarterly, monthly, weekly… or for a specific batch, reports are easily generated whenever you need them.

What does that actually translate into?

EM process stepsHours/monthCost/monthSaved/monthSaved/month
Reception of contact plates at QC22.5h€2,250-50%€1,125
Ordering plates & first reading50h€5,000-75%€3,750
Second reading40h€4,000-50%€2,000
Digitising results in Excel64h€3,200-100%€3,200
Double checks64h€3,200-75%€2,400
Trend analysis2h€100-100%€100
Document sorting1h€50-100%€50
Total243.5h €17,800 -€12,625

Time saved

on manual documentation work, including data collection, transcription, analysis and reporting.(1)

Productivity increase

through time-saving process automation, simplified compliance and real-time data analytics.(2)

Cut on costs

related to EM and QC operations thanks to digital workflows and processes.(1)

Deviation reduction

with much less errors and batch rejection thanks to digital instructions and built-in data integrity.(2)

Time saved

on document investigation workloads. Higher data integrity, stress-free audits and simplified compliance.(2)

(1)Customer data. (2)McKinsey’s 2019 report

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