header logo
 
 
 
 
 





 
 

The MIDI Sherlock Microbial Identification System (MIS) provides technological features that allow for compliance with 21 CFR Part 11.  This software package is called Sherlock Electronic Records and Signatures (Sherlock ERS). 

To read more about this federal regulation, view the FDA site at: http://www.fda.gov/ora/compliance_ref/part11/
To help you comply with FDA regulations, the Electronic Records and Signatures package incorporates the following features:

Sherlock ERS Fact Sheet
  • Preserves Agilent ChemStation raw data, Sherlock Sequences, and Sherlock Methods and Libraries associated with a set of analytical runs.
  • Data is stored in a single, secure file that cannot be altered by ordinary means.
  • Files are stored in a location determined by the system administrator.
    Maintains data integrity such that data can be utilized to regenerate the original results.
  • Electronic signature at operational points by means of a logon consisting of an operator name and password.
  • Permits review and verification of electronic records through a Windows- based user interface.
  • Provides designated authorized personnel with capability to review, approve and electronically sign records.
  • Creates an audit trail of all entries and actions that create, modify or delete an electronic record.

The MIDI Electronic Records and Signatures package is an integral part of Sherlock Version 4.5. Sherlock 4.5 is a full Windows-based system and has all of the associated ease-of-use features.  Users will now be able to easily view, and review data as well as generate reports.  The Electronic Signatures and Records package can be purchased as an optional software module when you upgrade your existing Sherlock software.

For additional information or to place an order
please send an email to: