The pharmaceutical manufacturing industry faces several pressures that are impacting its ability to bring safe and effective medicines from R&D to market faster and overcome issues like supply chain disruptions and competition. The pharmaceutical world is highly regulated and compliance management is both time-consuming and costly, while non-compliance can lead to significant fines or legal actions from organizations like FDA and the European Medical Agency. The Food and Drug Administration, for example, has the FDA 21 CFR Part 11 which dictates that electronic records of all drug manufacturing data needs to be available in raw uninterpreted format for at least 7 years for audits.
Pharma manufacturers are increasingly turning to the integration of digital technologies and automation to solve these challenges. This approach has been termed Pharma 4.0, which involves the use of advanced technologies such as artificial intelligence, machine learning, robotics, and Industrial IoT to improve operations and ensure compliance.