AIT Overturns PDMA Compliance Challenge
Published on: Mar 11, 2011
The Challenge:AIT’s corporate and Dallas teams had recently passed an extremely detailed and thorough Prescription Drug Marketing Act (PDMA) audit to begin handling business for a multi-specialty health care company.
However, within days of receiving a verbal commitment from the company, AIT’s Los Angeles station was notified that customer’s compliance department had expressed serious reservations about utilizing AIT’s services due to a misconception of AIT’s PDMA and Code of Federal Regulations (CFR) Part 11 audit and compliance results.
When the company’s legal team was finalizing all details of the contract, their compliance department intervened and decided that AIT was not in compliance with a particular section of the PDMA, which defines the criteria under which electronic records and data processes are considered to be equivalent to paper records. They made a recommendation to their supply chain team to stick with the incumbent provider rather than award AIT the business.
Instead of being deterred by the challenge and potential lost business, AIT quickly grouped together to discuss the customer’s concerns, identify why the recommendation was made and devise a plan of attack.
The Solution:Through many hours of research and PDMA compliance, AIT was ultimately able to determine that the customer’s compliance department’s findings were not accurate and did not support any reason for AIT to be denied the business.
AIT called a meeting with their supply chain, sample and compliance departments to disclose and present their findings.
After a constructive and mutually beneficial conversation, the customer agreed that their previous recommendation was a misconception and should be lifted.