In recent years, global and Latin American pharmaceutical regulations have undergone several updates in order to keep up with regulatory agencies such as FDA and EMA. One of the most important is the adoption of terms related to data; ALCOA, ALCOA+, Computerized Systems, Electronic Records and Signatures, among others. This is why currently the most resounding topics in the pharmaceutical industry are Data Governance and Data Integrity, i.e., maintaining paper and electronic records.
One of the departments involved in the generations of numerous records is the Quality Control Laboratory, which plays a fundamental role in guaranteeing the quality and safety of pharmaceutical products. One of the main challenges for the pharmaceutical industry is precisely to guarantee the integrity of the records that are produced throughout the production processes, both in electronic and paper format.