The Importance of Data Integrity
As previously mentioned in our last blog Data Integrity is the extent to which all data is complete, consistent and accurate throughout the data lifecycle. There has been an increase in regulatory emphasis on Data Integrity in recent years, as Data Integrity is such a major regulatory issue.
There have been many cases where data was compromised in the US, Canada, UK, India, China, Italy and in many other countries. Majority were due to 95% poor Data Integrity and Data Management practice issues and 5 % were issues with falsification fraud.
There are three different types of GMP regulatory bodies, the FDA GMP, EU GMP, and the WHO GMP. We will discuss these in our next blog post on how each of these can be broken down into levels of different regulations. Each one constitutes an essential part of the quality assurance system and is key to the operation of any compliance requirements.
Senior and Line management are responsible for the internal audit failures and all laboratory data questioned.
Majority of the warning letters that were issued between the years of 2013-2015 were:
– Problems with shared user identities
– No separation of system administrator functions
– No back up procedure
– Data deleted or lost
– Unofficial testing
– Work not contemporaneously documented
– Overwriting of data
– Audit trail turned off
– Audit trail not reviewed
– Complete data not available
– No standard, solution preparation details
These issues could have easily been avoided if the management kept on top of these problems. Management should ensure that the data that is generated is recorded, processed, retained and used to ensure a complete and accurate record of all data, the data is consistent throughout its lifecycle and leadership should have full technical control. Focus should be on the computer systems and records contained rather than paper output.