Importance of Plain Language in QA Documentation and Having the Right Mindset With Kathy Walsh

Life Sciences 360

Episode 010: Harsh Thakkar (@harshvthakkar) interviews Kathy Walsh (@drkathywalsh), the managing director and principal consultant at Quality Systems Now.
Kathy Walsh shares her experience working with clients to build and design effective quality management systems (QMS) and stresses the importance of integrating QMS into daily operations.
Harsh and Kathy discuss the challenges companies face when transitioning from paper-based to electronic QMS and offer tips for switching. They also touch upon how companies can improve their writing processes and the importance of clear and concise technical documentation.
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Links:
* Quality Systems Now
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Show Notes:
(7:58) The QMS systems market is just blowing up.
(12:11) Advice on how to improve documentation.
(18:30) Do you need a human to read a document?
(22:38) How to best interpret language in regulations?
(28:20) Defensive writing and compliance.
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For more, check out the podcast website - www.lifesciencespod.com

Chapters

1. Importance of Plain Language in QA Documentation and Having the Right Mindset With Kathy Walsh (00:00:00)

2. The QMS systems market is just blowing up. (00:07:58)

3. Advice on how to improve documentation. (00:12:11)

4. Do you need a human to read a document? (00:18:30)

5. How to best interpret language in regulations? (00:22:38)

6. Defensive writing and compliance. (00:28:20)