UDI, Data Printing & Audit Trail

Standard & Custom UDI Audit Trail or Printing configurations

Data Captured

Standard Dynamic Data per stroke:

   Time, Temp, Pressure of seal

   Date, Time, Odometer

   Recipe ID

   Product ID

   Lot #

   UDI

 

Access & Data Logging per event:

   Operator ID sign-on, PW enabled

   Supv/Eng ID sign-on. PW enabled

   Calibration ID sign-on, PW enabled

   ID change tracking

   Recipe change tracking

   Alarm tracking

   Calibration tracking

  

Access Details (click here)

Data Details (click here)

Retrofit Details (click here)

 

 

UDI, Printer Output & Audit Trail Data Overview

Standard Atlas Vac units have for years included dynamic output data (time, temp, psi, time/date, and recipe #) for output to PCL5 capable label printers as a means to capture and document unique package sealing data on each sealing stroke.

For 2016, with Class II UDI package labeling requirements and audit trail needs in mind, Atlas Vac has taken the next step to include data logging of not only the dynamic cycle data but also logging of Operator ID’s & PW, sign-ins, PW changes, UDI, recipe changes, alarms, odometer reading, etc all on a new standard 10” color touch screen

With our newest OIT color screens, scanning in lot codes and UDI information becomes easy and accurate.  This data is included in the audit trail database generated and can be transmitted to a label printer.  All without a PC and its inherent issues.

Easy to validate, outputs in human readable copy, protected data, retained record until uploaded, complete audit trail of sealing functions, audit trail of authorized personnel access, PW authority level access control, sealer data can be matched to individual device as input through UDI scan.

What is interesting, this capability can be retrofitted to many existing standard Atlas Vac units in the field as a means to enhance and extend capital equipment life.

Retrofit for UDI, Data, Printing & Audit Trail

Backwards compatible retrofit for extending your equipment life (click here).

What does this mean for you?

In the News:  www.medicaldesignandoutsourcing.com/atlas-vac-machine-plans-gain-udi/

First....no PC is used.  Therefore none of the OS updates and related software/firmware reliability issues. All our units are industrial PLC based.

When was a specific UDI packaged and under what exact parameters? By what operator?   Now you know!

What Engineer signed-on to edit the existing recipe parameters?  When? Now you know!

Can the Operator scan in the UDI, DI and/or PI information?  Yes!

When did someone with the Calibration PW sign in to update the calibration settings?  Now you know!

When was the last cycle alarm? What parameter violated? What was the cycle count reading? Now you know!

Did each seal cycle have readings within the set parameters?  Now you know!

Can you download this data for an audit trail? Yes!

 Not only do you know, you can prove it.