Case Study

How AstraZeneca Improved Validated Workflows In GMP API Manufacturing

Source: Dassault Systèmes BIOVIA
How AstraZeneca Improved Validated Workflows In GMP API Manufacturing

One of the primary challenges in implementing an electronic lab notebook (ELN) is getting buy-in from the myriad stakeholders who interact with the experimental data being recorded. Nowhere is this challenge more pronounced than in validated environments such as GMP manufacturing. In this area, the need to comply with strict regulatory mandates about how methods, processes and testing are documented and validated has led to even stricter internal controls that are codified in entrenched, paper-based workflows.