The Validation Department – a Producer of Data

Data Production

Hello, good people of the world! So you’re in Validation. Or any part of the Quality department. You don’t manufacture anything, you don’t sell anything – what is your role?

You are in the business of information, and you have many customers. Your first and most important customer may be the regulatory agencies your product(s) are subject to, but you’re also serving Manufacturing, Engineering, and the company owners and shareholders. That means you better be good at handling information.

What kinds of information are you handling in Validation? Well traditionally most of Validation’s output has been in the form of protocols and reports. But you may also handle deviations, change controls, impact assessments, plans, schedules, and any manner of associated data. How well is your data organized? Take this quiz:

  1. Can you produce a list of currently open validation packages?
  2. Do you know the percent of validation deviations still open after 30 days in the last year?
  3. Do you know the number of open change control requests with respect to system xyz?
  4. Do you know the number of requalifications scheduled for next month?
  5. If Validation Engineer Bobby Joe were to win the lottery and not show up to work tomorrow or ever again, would you know what open packages belonged to him?
  6. Do you know all the validated (or direct-impact) systems that use utility xyz?
  7. Do you know the boundaries of all your validated (or direct-impact) systems down to the valve or piping connection?
  8. Do you have a central location of materials known to be acceptable for your process with approved uses?
  9. Can you pull the calibration certificates for all critical instruments on system xyz from a central location?
  10. Can you access approved P&IDs and search them for tag numbers?

These questions and more can give you an idea of how good your information is. Data should be transparent and accessible, and there are many simple tools available to organize and share data these days.

How do you organize and share your data? Leave a comment below and please share this post with whomever you think would benefit.

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