Pharmaceutical manufacturers are looking for ways to reduce the time spent validating critical software systems without weakening the controls designed to protect product quality and regulatory compliance. That challenge will be part of the discussion at the 2026 ISPE Annual Meeting & Expo.
The event will take place from October 18 to 21, 2026, bringing pharmaceutical and biopharmaceutical professionals together in the Washington, D.C. area. Its program covers manufacturing, quality systems, regulatory expectations, supply resilience, facilities and emerging production technologies.
One of the sessions receiving attention ahead of the meeting focuses on computerized system validation, the process pharmaceutical companies use to demonstrate that software and digital systems involved in regulated operations work as intended.
Validation can involve requirements mapping, risk assessment, test development, execution, evidence collection and extensive documentation. ISPE has described the process as resource-intensive and potentially prone to human error when handled largely through manual workflows.
Automation moves into pharmaceutical validation
A session led by Frank Henrichmann of Q-FINITY Quality Management will examine how newer software tools can support different stages of computerized system validation.
The program includes the use of large language models and machine-learning tools for activities such as requirement assessment, automated test-case generation, test execution and evidence capture. The focus is not simply on reducing paperwork, but on whether these approaches can remain traceable and compliant in heavily regulated pharmaceutical environments.
Human oversight remains an important part of that discussion.
ISPE’s own technical coverage notes that automated systems still depend on clearly defined requirements, structured risk assessments and reliable input data. Qualified personnel remain responsible for reviewing outputs and making decisions that affect compliance and product quality.
Drug shortages and manufacturing reliability also on the agenda
The broader 2026 program extends beyond digital validation.
Sessions will examine pharmaceutical supply resilience and drug shortage prevention, including tools manufacturers can use to assess weaknesses before supply problems occur. Other parts of the agenda cover automated manufacturing for advanced therapies, continuous production, quality-system maturity and more sustainable use of energy and water in pharmaceutical facilities.
One track, Systems That Deliver Reliably, specifically looks at how manufacturing, facilities, quality and supply chain operations can work together while reducing environmental impact and improving resilience.
The combination reflects a wider challenge for pharmaceutical manufacturers: adopting faster and more automated processes while maintaining the level of documentation, quality control and accountability expected in regulated production.
The 2026 ISPE Annual Meeting & Expo will run from October 18 to 21 at the Gaylord National Resort & Convention Center in National Harbor, Maryland, in the Washington, D.C. area. The event also includes an Expo Hall featuring more than 350 exhibitors.
