Glossary
Audit Trails
What is audit trail?
Audit Trails is the documented information of activities and the reforms that are sequential in nature and affect certain operations, events or procedures. It focuses on who did what, when the action was done and other such matters. The audit trails are relevant to maintaining the data accuracy, quality, and it enhances compliance to regulations like GMP and GCP.
Why Audit trails are necessary in Pharma?
In industries which are subject to regulation including the pharma industry, the maintenance of data integrity especially when recording details of procedures carried out in the production of a pharma product is compulsory so as to meet the regulatory requirements.
Pharmaceutical audit trails are necessary in the documenting of records and necessary data for adherence to set regulatory measures, as well as transparency. They show a chronological document of events and alteration during the development, production, and distribution of drugs. Audit trails specify who did what, when they did it, and sometimes, why, in the form of formulation changes or inspections, guiding users on how to reconstruct activities and pinpoint when plans were not adhered to. The documentation is further beneficial for claims of compliance with the GMP and other regulatory authorities in the matter of quality assurance, inspection, and quality control hence the safety and efficacy of the products intended to be used by the patients.
