Mobirise

Micro-EM

Risk Based Environmental Monitoring Solution

Micro-EM is a risk based environmental monitoring solution manage sampling of controlled environments for  viable air particulates as well as surface viables, allows for assessment of effectiveness of cleaning/disinfection. allows for identification of trends and facilitate early detection of potential problems. Micro-EM is FDA CFR 21 Part 11 complies, achieving GXP, GAMP5, & FDA requirements and Comply with multiple sets of regulations agencies. Micro-EM manages and automates EM data in a scheduled and workload manner to facilitate EM automation. Simultaneous qualification of process capabilities and Integral handling of deviations and related tasks. 

Mobirise

Challenge & Solution

The FDA believes manual systems of environmental monitoring (EM) have large inherent operational risks, therefore they are difficult to validate, if it isn't documented, it wasn't done and if it wasn't done using an appropriate process, it wasn't done properly. Computer trending for pattern recognition is the most efficient and effective way to handle such large quantities of data. Rick Friedman
Micro-EM is a newly configured solution developed to handle environmental monitoring of controlled pharmaceutical areas. 

FEATURES

Micro-EM™ is one solution for multiple integrated and dynamic functions plotted in various metaphors,

FDA CFR P11
Complies

Achieving GXP, GAMP5, & FDA requirements and Comply with multiple sets of regulations agencies. 

Sample management

The quality of the laboratory work is only as good as the quality of the samples it uses for testing. 

Process Quality Review

Micro-EM is a a major tool for operational management of laboratorie to ensuring smoother control processes. 

Reporting Services

From the sample registration to the final reporting, full laboratory management reporting system.

OOS Investigation

Micro-EM collect and manage effectively the test results which fall outside acceptance criteria . 

Visual Representation

Experience your data, any way, anywhere and view a complete picture of your informations in graphical manner.

Dedicated
User Profile

Micro-EM provides for each registered user a dedicated profile includes user documents, tasks and requestitions.

Security & Authority

The security administrator authority possesses the ability to manage roles and user security objects. 

Free Trial

$ 0 .00
  • 30 days free trial full featured demo includes: 
  • Design Management
  • Risk Management
  • Sanitization Management
  • Scheduling
  • Monitoring System
  • Process Review
  • OOS Investigation
  • Task Management
  • User Profile
  • Single user

Standard Plan

$ 1,495 .00
  • Suitable for regular laboratories and includes:
  • Design Management
  • Risk Management
  • Sanitization Management
  • Scheduling
  • Monitoring System
  • Process Review
  • OOS Investigation
  • Task Management
  • Audit Trail
  • User Profile
  • For 10 users

Professional

$ 1,995 .00
  • Best choice for professional laboratories:
  • Design Management
  • Risk Management
  • Sanitization Management
  • Scheduling
  • Monitoring System
  • Process Review
  • OOS Investigation
  • Task Management
  • Audit Trail
  • User Profile
  • Unlimited users
  • Roles and Permisions
  • Validation Packge

Advanced

$ 2,495 .00
  • Request advanced plan only for Special Orders:
  • Design Management
  • Risk Management
  • Sanitization Management
  • Scheduling
  • Monitoring System
  • Process Review
  • OOS Investigation
  • Task Management
  • Audit Trail
  • User Profile
  • Unlimited users
  • Roles and Permisions
  • Validation Packge
  • URS Customization
  • KPIs