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Automate Your Validation of Pro/ENGINEER Drawings After a Migration or Upgrade.

  • How do you validate that your Pro/ENGINEER drawings haven’t changed after an upgrade or a migration?
  • Are you subject to FDA audits and proving compliance to software validation in regards to Quality Systems Regulation Title 21 CFR Part 11, Part 820 and 61 FR 52602?

 
Migrating Pro/ENGINEER drawings from Pro/INTRALINK to PDMLink can cause irregular changes to your drawings. Since software validation is a requirement of the FDA’s Quality Systems Regulation, Fishbowl has developed a solution to help automate the validation of Pro/ENGINEER drawings during a migration or upgrade.    
 

linkTuner HPGL Compare is the only tool to automate the validation of Pro/ENGINEER drawings after an upgrade or migration to PDMLink.


HPGL Compare Drawings

Can you tell if your data has changed?                               Do you have the time to find out?


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HPGL Compare Product Specifications

As an add-on to our linkTuner solution, HPGL Compare creates HPGL files of any drawing used during a linkTuner run. Once created, HPGL Compare will run a secondary process to compare the files to insure a pre-migrated data set matches a post migrated data set.  HPGL Compare then outputs an image identifying where on the drawing changes occurred. HPGL Compare can also leverage ProductView, where installed, to highlight changes on the Pro/ENGINEER drawing itself.

HPGL Compare GUI, Summary, and Diffs Image

linkTuner HPGL Compare validates data during:

  • Migrations from Pro/INTRALINK 3.4 to PDMLink 9.x
  • Upgrades from PDMLink 8.0 to 9.x
  • Upgrades from Pro/ENGINEER Wildfire 1.0 to 5.0 and everything in between. 

HPGL Compare Brochrue

icon_pdf.gif HPGL Compare Brochure

HPGL Compare Use Case

Medical Device Company

A medical device company was migrating thousands of Pro/ENGINEER drawings from Pro/INTRALINK 3.4 to PDMLink 9.1. As they began their migration, they became aware that Pro/ENGINEER drawings can change during a migration or upgrade. This was of great concern to them because, as a medical device company, they are required to comply with the FDA's Quality Systems Regulation, which requires them to perform software validation to ensure accuracy, reliability, and the ability to discern invalid or altered records. 

Knowing that some of their drawings had changed, the company was faced with the task of manually validating every Pro/ENGINEER drawing pre and post migration to insure their data was accurate.  This was a daunting task that they estimated would take hundreds of man hours to complete. At a burden rate of $75 /hour and an estimated 5,000 drawings, the cost for manual validation would be upwards of $37,500.
 
Using Fishbowl Solutions’ HPGL Compare, the company was able to validate their Pro/ENGINEER drawings in a single day. HPGL Compare automates the drawing validation process by creating HPGL files of the drawings and then comparing the pre and post representations, validating nothing has changed. If HPGL Compare finds inconsistencies it provides a graphical representation of changes to the drawing.
 
HPGL Compare saves the medical device company not only the approximately $37,500 in manual validation costs, but also helps them mitigate risks associated with system audits and non-compliance to the FDA’s Quality Systems Regulation.
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