Microbiology Information Management System
The Microbiology Information Management System (MIMS®) provides a validated method of documenting and assessing facility operations.
By integrating features that not only record QC/EM tests and results, but also analyze and trend that data, MIMS ensures that your environmental control systems are operating as intended. These trends can provide valuable insight into the effectiveness of decontamination procedures, housekeeping practices, and personnel training, as well as identify the potential for microbial build-up during production.
By integrating features that not only record QC/EM tests and results, but also analyze and trend that data, MIMS ensures that your environmental control systems are operating as intended. These trends can provide valuable insight into the effectiveness of decontamination procedures, housekeeping practices, and personnel training, as well as identify the potential for microbial build-up during production.
Key Features
- Support for a wide variety of predefined tests (i.e. particulate, microbial) as well as user defined tests (i.e. pH and chemical), including water testing
- Generates worksheets (data sheets) and corresponding barcode labels to facilitate sample identification
- Custom visual layouts of facilities and test sites
- Store and display digital photographs and videos
- Ability to generate e-mail notifications with optional historical data trend for "Alert Level" and "Action Level" conditions
- Ability to generate e-mail notifications with optional historical data trend in the event that "flagged" organisms are identified
- On-line review confirmation
- Tracks media expiration
- Tracks equipment calibration dates
- User-defined report generator
21 CFR Part 11 Compliance
- Custom levels of security that restrict access and data modifications. Permissions can be granted to only certain functions within the application, as well as to only certain buildings or areas within the database.
- Electronic signature feature required for any inserts, updates, or deletions performed throughout the system
- Security lock-out feature
- Security time-out feature
- Password expiration
- A secure, non-modifiable, read-only / print-only audit trail automatically captures all modifications within the database
The Case for MIMS
There is a constant challenge for companies involved with aseptic processing to maintain a high degree of environmental control in order to avoid product contamination. Manufacturers seeking to address those challenges have several options:
Type of Solution | Development | Implementation
& Configuration | Reliability and
Integrity | CFR 21 Part 11 Compliant | Cost |
Spreadsheets | Easy | Easy | Poor | No | Low |
Custom Applications | Difficult | Moderate | Varies | Possibly | High |
Full LIMS | N/A | Difficult/Extensive | Excellent | Yes | Very High |
MIMS | N/A | Moderate | Excellent | Yes | Moderate |
MIMS has been specifically designed to manage environmental monitoring data in accordance with regulatory requirements and industry guidelines, and provides a cost-effective solution that is meaningful, manageable, and defendable.