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The MIMS provides a
validated method of assessing and documenting facility operations,
collecting results from (but not limited to) microbial, particulate, and
water tests, and analyzing and trending the data. This ensures that the
environmental control systems are operating as intended.
These trends provide valuable insight into the effectiveness of
decontamination procedures, housekeeping practices, personnel training,
and the potential for microbial build-up during production.
The MIMS is an "off-the-shelf," user configurable
means of electronically documenting, capturing, and reporting on
your environmental monitoring program. CSSC will configure the database
to "mirror" your SOP's and facility diagrams, install the
system in your facility, and train all personnel based on
their assigned security permissions.
The MIMS may be upgraded once per calendar year and released to all
customers as part of their Annual Maintenance and Upgrade Agreement with CSSC. The
upgraded features are typically the recommendations of our current users.
All users are encouraged to submit their ideas and suggestions.
Technology upgrades and regulatory / industry changes may also be included in the upgrade.
The MIMS application was developed using a Microsoft®
development program, Visual Studio.net. It is compatible with virtually
all existing network configurations, making it easy to integrate into
existing systems and requiring a minimal amount of hardware and software to
effectively operate (Hardware / Software Requirements). It can be implemented
with either an SQL ServerŽ, or OracleŽ database.
Included with your site license for the MIMS
is:
- A copy of the MIMS Release Testing
- System Use SOP
- Template document for performing the Installation Qualification
(IQ)
- Template document for performing the Operational Qualification
(OQ)
- Template document for performing the Performance Qualification
(PQ)
- User Manuals
- Training Manuals
Some of the key functionality of the MIMS includes:
- Supports 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 utilizing
Microsoft Visio®
- Store and display digital photographs and videos
- Ability to generate e-mail notifications with optional
historical data trend for "Alert Level" conditions
- Ability to generate e-mail notification with optional historical
data trend for "Action Level" excursions
- Ability to generate e-mail notification with optional
historical data trend in the event that a "flagged" organism is identified
- Automatic e-mail notification when a user is "locked out" of the system
after 3 unsuccessful login attempts
- On-line review confirmation
- Tracks media expiration
- Tracks equipment calibration dates
- Includes a report application that enables users to create and
save custom created reports
Features that address the requirements of 21
CFR Part 11 includes:
- 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
Download a PDF
copy of CSSC's
21 CFR Part 11 Assessment Statement of the MIMS.
Request a copy of the MIMS Presentation Binder.
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