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Automating Quality Operations in the Biotech, Pharma, Medical Device, R&D and Clinical Trial industry

Who Says Automating Quality Operations Isn’t Sexy?

Quality Management - 2 August 2017

Automating quality operations isn’t typically seen as being sexy, I know. But if automating your quality operations saves you time on essential tasks, thus saving you money, and saving money is sexy, then isn’t automating quality operations, in turn, also sexy?

Like any entrepreneur, I enjoy making money, but as the head of a company that serves a large number of clients, I feel a particular sense of satisfaction when I can help our clients save money by providing them with tools and advice that will improve the speed of their daily quality operations.

Here are a few examples of what I mean:

  • Simplify Change Controls
    If you have, say, 1500 Change Controls per year, in my experience, it’s likely that you can remove unnecessary steps from a significant number of them by building a simple matrix and committing to using a more comprehensive Change Control only when it’s absolutely necessary.
  • Reduce Delays
    What about the value of approving a change ‘now’ on your cell phone while visiting a plant overseas? Reducing small delays here and there may have an important impact on your cycle times and even on your work life as a whole.
  • Defined Process Owners
    By automating quality operations, you are forced to clearly establish who a CAPA, Deviation or Complaint process belongs to – thus helping you to improve speed by no longer having to devote time to reminding everyone what they should do next and how.
  • Training Records Management
    Can you put a dollar amount on having your Training Records in control at all times? In my experience, that amount is typically very high.

A great Enterprise Quality Management System (EQMS), once implemented, is similar to a great accounting system in a sense that you will eventually forget all about it, you will run better and focus on making more money.

Be impatient until you get there, be restless until it’s taken for granted, and you will make money, seriously.

About the Author
As CEO of SOLABS, and almost 18 years after co-founding the company, Philippe Gaudreau continues to grow an avid interest in quality management and compliance practices in the Life Sciences. He is passionate about finding best in class solutions, with the goal of helping our Life Sciences clients automate their quality operations without losing the flexibility they have with their manual systems. He offers his expertise through his devotion to software development, his deep knowledge of business process management and optimization, and his expertise in document life cycle management.

More Articles by Philippe Gaudreau
Document Control & Change Control: Periodic Reviews & Retraining
Document Control in GxP Regulated Industries
Good Practices for Document Control: Categorizing, Classifying & Tagging

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