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Validation
 

The MicroLog™ and OmniLog® Validation Packages provide you with all the important components you need to validate your Biolog system's performance specifications.

Validating a microbiological identification system's process can be a laborious and challenging task. The Validation Protocol Manual included with the MicroLog Validation Package provides an easy-to-use, step-by-step approach that greatly simplifies the task. Included in the manual are sections covering Installation Qualification (IQ) and Operation Qualification (OQ), as well as appropriate Standard Operating Procedures and Preventative Maintenance.

 
 
21CFR Part 11
 

The MicroLog and OmniLog® systems are designed to exist within a 21CFR Part 11 environment and provide the basic functionality to support our customer's compliance efforts

The objectives of the original regulation are to ensure integrity of electronic records by:

  1. Limiting access
  2. Providing documentation of what was changed, by whom, and when
  3. Providing audit trails
  4. Ensuring that original record files cannot be modified.
 
Validation Support Products:
 
MicroLog Validation Package
 
The MicroLog Validation Package (Catalog No. 3960) provides all the important components a MicroStation user needs to validate their system's performance specifications. It comes with the Validation Protocol Manual, a special printer cable, and two sets of 22 test organisms.
 
OmniLog® Validation Package
 
The OmniLog® Validation Package (Catalog No. 90911) provides all the important components an OmniLog® user needs to validate their system's performance specifications. It comes with the Validation Protocol Manual and two sets of 22 test organisms.
 
Biolog Validation Strain Set
 

The MicroLog Validation Strain Set (Catalog No. 3961) is a single set of 22 test organisms and is primarily for re-validating systems.

 
 
 
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