Are you protecting the date/time function on your equipment?

Are they password protected?

A company recently received this 483 observation: 

…..Supervisory oversight over the laboratory electronic systems and data is deficient.

Specifically, during the inspection of your Quality Control (QC) Test Room on the second floor of the QC building, where multiple electronic balance scales are located, I observed several electronic scales with functional printers.  It was discovered that the password function for date/time was not locked and restricted from QC personnel. Printouts from these electronic scales are used as original records to document weighing of materials and samples and are attached to analytical batch records. Per your firm, 12 out of ….. electronic scales do not have a password function option for date/time to be locked.

For more observations pertaining to data integrity see Issue 1020 available today.  It has has observations pertaining to manufacturing controls, laboratory controls and medical device manufacturing controls.

Also out today are 2 additional reports. Our Quarterly Special Report  is a comprehensive report on observations pertaining change control.  Our second report out today is the Facility Inspection List from Q1-2019. This report is a summary of FDA Inspections that were conducted between January 1, 2019 and March 31, 2019.  The report is in excel format and allows you to sort as you need.  The report includes whether or not facility received a 483, length of inspection and CFR citations where available.   These reports are free if you subscribe to our Professional Subscription package.

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