Data Integrity Training
FDA’s emphasis on data integrity and electronic record compliance causes anxiety, confusion and frustration. What is “data integrity” as it relates to day-to-day activities? to data entry versus data review and manipulation and reporting? to data transmittal from one system to another? to data archives of historical records?
And who is responsible for data integrity? You? Your supplier? Both of you? When does data integrity start? At system login or when actual regulated data is first entered?
During an onsite corporate training workshop on data integrity for a multi-national medical device firm, Cerulean provided answers, examples, and steps to take for all of these questions to executives from Quality, IT, Laboratories, Manufacturing, and senior management. Here’s what the Quality Director had to say:
“We really like John Avellanet’s attitude of “do what you need to do – don’t do what you don’t have to do.” The weight of his experiences and real-life, recent examples presented by John in our training got the message home to the staff and management team. Everyone now understands that data integrity is something that we cannot take lightly and we have put resources into it. John gave us a pragmatic, business-oriented model to compliance that really works for us.”
– Patricia Buck, Director, Quality, Huntsville, Alabama
If you are looking for a trustworthy data integrity expert, John Avellanet has been dealing with and solving data integrity issues since the days of the TRS-80 and the early versions of MS-DOS. Take a look Cerulean’s specialized data integrity Part 11 consulting services, or download and read some of our “how to” articles. And contact Cerulean when you are ready for data integrity training tailored to your needs that will give you the answers and the specific steps to take.
Contact Cerulean today and start making compliance easier