Warning Letter – Biochem Laboratories Inc

Recipient:Biochem Laboratories Inc.
Product:TX1 Tissue Removal System
Date: 2/17/2012

Your firm has failed to exercise appropriate controls over computer or related systems to assure that changes in master production and control records, or other records, are instituted only by authorized personnel [21 CFR 211.68(b)].

For example:

a. Your firm did not put in place requirements for appropriate usemames and passwords to allow appropriate control over data collected by your firm’s computerized systems including UV, IR, HPLC, and GC instruments. All employees in your firm used the same usemame and password. In addition, you did not document the changes made to the software or data stored by the instrument systems. Without proper documentation, you have no assurance of the integrity of the data or the functionality of the software used to determine test results.

b. Your firm had no system in place to ensure appropriate backup of electronic raw data and no standard procedure for naming and saving data for retrieval at a later date.

In your response, you state that you will maintain backup of electronic raw data and all technicians will have their own user identification (ID) and password. Your response, however, is inadequate because you do not describe how your firm intends to save and back-up the electronic raw data, nor whether your firm will implement audit trails on your computerized systems. Further, you do not provide a timeframe for accomplishing the intended corrective actions or describe the changes you have made to relevant SOP(s)..

Issuing Office: New Jersey District


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