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Manual Processes Result in More Errors

Data in the Cloud Can Be 21 CFR Part 11 Compliant

How modern technology and automation help you achieve better quality and compliance.

Manual testing is tedious. Brains tend to switch to autopilot mode and are more prone to overlook errors or inaccuracies in what’s being tested. Depending on the scenario, reviewers may not have the knowledge, experience, or tools necessary to accomplish the task. When large data sets are being audited for business insights and decision-making, manual testing and review slows down the time to discovery and your organization loses out on the timeliness and usefulness of the data.

Overcome the hindrances of manual testing

Implementing process automation and quality by design help you to simplify, scale, and maintain regulatory compliance. Additionally, moving from manual to automated testing helps your organization to:

  • Use batch testing for quality control.
  • Be consistent in how testing is performed.
  • Support regression testing during software development.
  • Compare large amounts of data in a short amount of time.

As life sciences companies progress in their automation maturity—from rule-based automation to virtual agents, cognitive agents, and AI/machine learning—USDM offers solutions to optimize use cases and applies computer software assurance (CSA) to drive efficiency. Watch the Automated GxP Cloud Compliance session from the USDM Life Sciences Summit to further explore this topic.

Experience automation and continuous validation

ProcessX is a fully validated, GxP process automation platform built on the ServiceNow technology stack. Its compliance and AI capabilities help Quality and IT leaders gain greater insight into the entire product lifecycle and supply chain to minimize costly recalls and undetected systemic issues.

Together, ProcessX and the USDM Cloud Assurance solution automate and maintain validation and testing. Cloud Assurance delivers continuous validation and meets the necessary global regulatory requirements beyond the U.S. Food and Drug Administration 21 CFR Part 11 regulations on electronic records and electronic signatures. Read the 2023 Technology Trends in Life Sciences white paper to learn more.

Hear industry experts from Google Cloud, ServiceNow, and PTC discuss progressive technology that helps them focus on solving life sciences challenges—watch the on-demand session from the USDM Life Sciences Summit.

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