This webinar, Practical Software Assurance within the Life Sciences, provides a realistic and actionable understanding of how regulated organizations can manage software in ways that protect patients, ensure product and data quality, and meet global regulatory expectations without wasting resources on unnecessary documentation.
Life-science companies are increasingly dependent on software to support manufacturing, laboratory operations, clinical research, quality management, document control, training, product release, data trending, and supply chain activities. As these systems grow more complex especially with SaaS, cloud-hosted platforms, and configurable applications regulators are pushing industry to shift away from traditional Computer System Validation (CSV) as a paperwork exercise and toward true Software Assurance, where risk thinking and intended use drive activities.
Rather than focusing on producing piles of documents or validating every system feature, Software Assurance emphasizes understanding a system’s intended use, identifying where failures could impact patient safety or product quality, and tailoring evidence accordingly.
The session explains how to determine the real-world impact of a software system, function by function. It distinguishes GxP-critical systems (such as production control or laboratory data systems) from GxP-supportive systems (like training platforms or trending tools) and non-GxP tools that do not require formal assurance. It covers how to assess risk in a meaningful way that influences testing depth, supplier qualification, and change control expectations.
The webinar clarifies what global regulators actually expect, debunking misconceptions that compliance requires exhaustive test scripts, blanket traceability to every requirement, or validation of vendor functionality that the organization will never use. Instead, the session explains how FDA’s Computer Software Assurance guidance, EU Annex 11, 21 CFR Part 11, ISO 13485, IEC 62304, and GAMP 5 Second Edition all consistently require the same principles: critical thinking, proportionate evidence, and lifecycle control.
Participants learn where auditors are now focusing such as configuration controls, data integrity protections, vendor responsibilities, cybersecurity readiness, and traceability of decisions.
The session also offers practical strategies for building evidence that matters, including concise intended-use statements, risk-focused test plans, targeted traceability that demonstrates control, and smart use of supplier documentation. Attendees learn how to determine when exploratory testing is appropriate, when scripted testing is required, and when supplier test evidence can replace internal duplicative testing. Clear examples are provided to demonstrate pitfalls such as screenshot overload, validating unused features, or blindly relying on vendor documents.
Finally, the content addresses vendor and cloud provider expectations, including supplier qualification proportional to risk, appropriate contract and SLA language, change notification requirements, business continuity responsibilities, cybersecurity ownership, and audit cooperation expectations. Participants gain clarity on shared responsibilities for SaaS environments and how to ensure data integrity and traceability when systems are cloud-managed.
Overall, this session arms attendees with the knowledge to implement Software Assurance that is efficient, compliant, risk-based, and defensible during audits all while focusing on what truly protects patients and product quality.
Why should you Attend:
Professionals across the life sciences are under increasing pressure to implement computerized systems in a way that is both fully compliant and resource-efficient. Unfortunately, many organizations still rely on outdated, document-heavy approaches to Computer System Validation (CSV) that create excessive paperwork, slow deployments, and provide little protection against real regulatory risk.
This webinar brings clarity to that challenge by showing participants how to apply practical Software Assurance principles that focus on patient safety, data integrity, and intended use rather than on producing validation binders that no one reads.
Participants will benefit by learning how global regulators now expect software to be evaluated and controlled. Instead of wasting time validating every feature or duplicating vendor testing, attendees will understand how to determine what truly requires evidence and how much is appropriate based on risk. This allows teams to implement systems faster, avoid unnecessary costs, and deliver documentation that stands up to audit scrutiny because it reflects what the system actually does.
The training also addresses one of today's biggest pain points: working with cloud providers and software vendors. Many organizations struggle with knowing when to rely on vendor testing, how to qualify suppliers, and what contracts or service agreements must include to protect regulated use. This session provides actionable guidance that can be applied immediately to ongoing projects, future implementations, and existing systems requiring remediation.
By taking this training, participants will reduce audit exposure, improve compliance quality, streamline validation workload, and increase organizational confidence in software assurance decisions making them more effective and valuable in their roles.
Areas Covered in the Session:
