In 2016, 80% of the FDA warning letters were issued due to the lack of data integrity. The main reason was incomplete data, an aspect that can be prevented by using the right solutions. The highest risks, when not working in a compliant manner, lie in import ban, product re-call or closing of production plants.
For laboratories that must comply with GLP, GMP and GAMP regulations it is important to have records or documented evidence of all relevant analyses that can be checked by a second person and also readily available for audits. Storing the result is not enough, each result set has to be complete and contain all relevant meta data.
Good titration procedure presents just such a case: a best practice workflow captures complete titration chemicals data.