MODA | Paperless Pharmaceutical QC Micro Environmental Monitoring (EM)

Solution Overview

MODA addresses paper-based challenges in QC Micro

In the pharmaceutical industry, problems with product safety and efficacy due to contamination issues make the front page headlines all too often. The cost of a recall due to real or even a suspected contamination event is incalculable when one factors in the risk to consumers and the loss of brand confidence. MODA is dedicated to helping our clients prevent incidents like this from ever occurring.

Regulating agencies require comprehensive QC Micro programs to ensure that processing areas are under control for potential viable and non-viable contamination. However, the traditional paper-based QC Micro processes are expensive, error-prone, and time and labor-intensive regardless if they are managed by small biotech companies or large pharmaceutical manufacturers.

Manual processes yield inefficiencies

Common manual paper-based process steps still burden most QC Micro programs: paper scheduling, sharpie pen labeling of sample media, manual reconciliation, paper log book entry, and manual notification on deviations.  Test results are stored in shelves of paper binders, a challenge to quickly navigate during an audit.   For Corrective and Preventative Action (CAPA) purposes, building a set of trend reports may require more than eight weeks. Unfortunately, by the time a trend of activity is developed and recognized, the condition causing the trend is likely to have changed—making it difficult to support corrective action activities—and nearly impossible to perform meaningful preventative actions.

MODA: a comprehensive solution for the life sciences industry

MODA offers the market a proven, flexible means to achieve the goal of a paperless, automated quality organization. The MODA solution ties together automated scheduling, workflows, mobile data acquisition, device integration, and advanced analytics. By doing so, the aforementioned manual, paper-based tasks are removed, saving time and money while improving compliance.

The MODA solution covers the broad spectrum of your entire QC Micro program with unique workflows and device integration for:

•  Environmental Monitoring
•  Utility Testing
•  Product Testing

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