Documentation in the world of highly regulated industries is, without question, critical. Hundreds of thousands of dollars – if not millions – are at stake if the FDA regulatory authorities discover gaps in documentation requiring a shutdown and remediation. And of course, more than money, is the risk of patients being without treatment. In our past two blog posts we have discussed Superior Controls’ documentation processes which have been tested and proven by passing 50 consecutive customer FDA required audits in industries including biotech, medical device and pharmaceutical.
The following is an example of how we put our documentation process expertise and experience to work to mitigate losses for a manufacturer who was subject to an FDA shutdown.
The medical device manufacturer’s voice sounded desperate over the phone. The FDA had just finished a surprise inspection and identified significant missing validation documentation for over 100 pieces of automated machinery and equipment producing medical devices. They were going to be shut down! Could Superior Controls provide reverse engineering, validation documentation and testing to comply with the FDA requirements?
The panicked phone call to Superior Controls and subsequent meeting with a major medical device manufacturer turned into a blizzard of work over the next 15 months and involved 10 Superior Controls Project Engineers and 2 Validation/Project Engineers, many weekends and 80-hour work weeks.
The work pace however, was purposeful, organized and systematic. First, the engineers examined each piece of automated machinery, reviewed the ladder logic and wrote the associated design specifications – documents describing exactly how the machinery functions along with a list of alarm thresholds, setpoints and interlocks. In addition, our engineers developed a Site Acceptance Test (SAT) for testing the hardware and software to prove that the machinery functioned properly.
The document creation task was accelerated by our engineers using the Superior Controls’ GAMP 5 templates which had been used previously on hundreds of validated projects. Our customer called these templates our secret ‘turbo-charger’ for validation document creation and noted that this was a major reason why we were hired.
When we completed testing and assembling documentation (over 100 documents) for the 24 systems, our customer was able to get the authorization to again begin shipping product from those machines.
After the systems were fully validated and tested by Superior Controls, the validation documentation was stored and backed up by Superior Controls, and provided in both paper and electronic format to our satisfied and relieved customer. They have been shipping product ever since.
If you are interested in an assessment of your current documentation, contact us to schedule an evaluation. To read more about our documentation processes and methodology, see our prior two blog post: Superior Controls Gamp 5 Documentation and What Sets Us Apart and Superior Controls Documentation And What Sets Us Apart – Part 2.