REGULATORY AND COMPLIANCE

How sure are you that your cleanrooms are in compliance?

Let’s first kick off this discussion with the roles of Quality and Regulatory.

As far as Quality is concerned, they have to help put systems and processes in place that will allow the company to be able to offer objective evidence that regulations, rules, SOPs, standards, and laws are being followed. Quality is the proof of what the company says it is doing and that proof is in compliance. To what end, though?

Quality invariable leads to Regulatory. In each case, the objective evidence must show Regulatory (both internally and externally) that the company can be trusted to 1) know the rules, and 2) follow the rules. Any detraction from this objective evidence (e.g., unsigned forms, lost evidence, illegible evidence, etc.) can be construed by Regulatory as a violation of just basic Good Documentation Practices. Violations lead to 483s. 483s lead to investigations. Investigations are wasteful activity and add to your cost of quality (meaning are measurable forms of Cost of Poor Quality.)

You may believe you’re in compliance, but regulatory agents still have to verify this. It’s the cost of doing business in a regulated industry. Wouldn’t it make sense to dramatically reduce or eliminate the opportunity for waste, human error, and unproductive time spent?

Of course it does.

This is why Clean Spaces was developed. After seeing the sheer amount of WASTE in industry and in having to live with the amount of waste considered “normal” over my 30+ years working in these industries, I knew that there had to be a much better way to be able to provide objective evidence to regulators in which there was no real possibility of human error, no human manipulation of data, and a way to present objective data in a manner that least affects the company but gives the highest amount of confidence of compliance.

Imagine…being able to have your operators input the same data they always have but in a format that eliminates all subsequent activities that add up and take away from the corporate bottom line. You’ll save money by automating. You’ll also prove compliance by automating.

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Mark Proulx has been working in the Medical Device and Pharmaceutical industries for over 30 years. His company, Clean Spaces App LLC, has been involved in developing a patent pending cleanroom management application that automates the process of providing objective evidence to regulatory authorities for companies to prove cleanroom compliance by automatically recording, analyzing , and outputting the data that is collected by staff on a routine basis. Areas to be inputted and outputted are Cleaning, Disinfecting, Particle Counts, Micro Counts, Audit Logs, Charts and Graphs, and training tutorials. For more information on the app, go to: www.cleanspacesapp.com