Recently on one of the busy Monday mornings, I was driving to a client place at Bangalore. But near Chalukya junction, as I was crossing the signal, the light went from yellow to red. Traffic police immediately indicated me to stop and I did so as an honest person. I was not clear what violation had I done but traffic police said I was in yellow gridlines and it is zero tolerance zone. I was told to pay the traffic violation fine. Now it was time to record my violation and pay the fine. Being an integral person, I paid the fees and continued my drive to the destination.
If I have to analyze the above case, firstly, I was not aware of “Zero tolerance zone” and secondly, I could have avoided the recording of traffic violation and paying fine by other means or bribing. But I was probably honest, so stopped the car and paid the fine as an integral person. In my opinion “one can have honesty without integrity, but one cannot have integrity without honesty”.
Last month I have conducted a workshop on “Data Integrity -Audits and Compliance” and a good number of people from various Pharmaceutical and Biopharmaceutical companies had participated in the same. One of the major points that came to my observation was about the challenges faced in adhering to Data Integrity (DI) because of the lack of knowledge or lack of clarity on the basics or interpretation of regulation and mainly culture.
Additionally, through interactions with people in Pharma and Biopharma industry and also from regulatory observations, I interpret that majority of the companies are yet to initiate exclusive internal audit by trained and qualified people on DI. Or, is the industry observing the above DI challenges in spite of internal audits? I opine that exclusive internal audit by trained and qualified people in DI , specifically focusing on awareness of basics on Records & Data Integrity (RDI), what, how and when of Data review and most importantly human behavior and culture might definitely help the industry to face the said challenges.
Finally, to quote Benjamin Franklin, “By failing to prepare, you are preparing to fail”. Let us make our inadequate review and internal audit on RDI more meaningful so that it adds value to our system, business and thereby we deliver safe, efficacious and quality medicine to patients and also give confidence to the competent regulatory authorities
If I have to analyze the above case, firstly, I was not aware of “Zero tolerance zone” and secondly, I could have avoided the recording of traffic violation and paying fine by other means or bribing. But I was probably honest, so stopped the car and paid the fine as an integral person. In my opinion “one can have honesty without integrity, but one cannot have integrity without honesty”.
Last month I have conducted a workshop on “Data Integrity -Audits and Compliance” and a good number of people from various Pharmaceutical and Biopharmaceutical companies had participated in the same. One of the major points that came to my observation was about the challenges faced in adhering to Data Integrity (DI) because of the lack of knowledge or lack of clarity on the basics or interpretation of regulation and mainly culture.
Additionally, through interactions with people in Pharma and Biopharma industry and also from regulatory observations, I interpret that majority of the companies are yet to initiate exclusive internal audit by trained and qualified people on DI. Or, is the industry observing the above DI challenges in spite of internal audits? I opine that exclusive internal audit by trained and qualified people in DI , specifically focusing on awareness of basics on Records & Data Integrity (RDI), what, how and when of Data review and most importantly human behavior and culture might definitely help the industry to face the said challenges.
Finally, to quote Benjamin Franklin, “By failing to prepare, you are preparing to fail”. Let us make our inadequate review and internal audit on RDI more meaningful so that it adds value to our system, business and thereby we deliver safe, efficacious and quality medicine to patients and also give confidence to the competent regulatory authorities
