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This week, Stacey is joined by Harsha Chulki and Stephen Cook. Validation documents are critical to both the internal processes, and external communications, in regulated industries such as pharmaceutical and medical device organizations. Properly recording and managing data is necessary to ensure the integrity and reliability of records. Good Documentation Practices (GDP) lay down the guidelines for preparation, recording, and correction of data as well as the maintenance of the records throughout the lifecycle of a document.


Resources for episode:


• Compliance Group Webinar Resource: https://www.complianceg.com/webinar


• Follow Compliance Group Blogs: https://www.complianceg.com/blog


• Annex 5 - WHO | World Health Organization


• PQ Forum #10: Technical Writing for Validation


• PQ Forum #18. PV Stage 1 Technical Report Format


Harsha Chulki is the Head of Global IT, Quality & CSV at ICU Medical. He is a seasoned IT leader with over 15 years of leadership and program management experience building multiple, high performing teams across multiple industries. Chulki is also the Architect of Integrated IT Compliance model with experience installing centralized controls across IT (GxP, SOX, HIPAA, Non-GxP). He can be reached at [email protected]


Stephen Cook is the VP, QUALITY AND COMPUTER COMPLIANCE at Compliance Group Inc. He has 20+ years of experience in the field of computer systems validation and is an expert on Computer Software Assurance (CSA). He believes that a strong partnership between IT, Quality and the business can lead to creative solutions and that the really good work gets created outside the SOP. He can be reached at [email protected].


Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.