How modern technology and automation help you achieve better quality and compliance.
The short version: Manual testing and review are slow, inconsistent, and error-prone—especially as data sets grow. Moving from manual to automated, continuously validated processes helps life sciences organizations improve quality, speed up time to discovery, and sustain regulatory compliance as their automation maturity advances toward AI and machine learning.
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.
When brains switch to autopilot, errors slip through. Automation gives quality and IT teams a consistent, repeatable way to test at scale.
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.
Faster, more consistent testing is also a data integrity advantage: automated checks reduce transcription mistakes and produce a cleaner, more reliable audit trail when large data sets are reviewed for business insights.
Why it matters: Inconsistent manual testing doesn’t just cost time—it weakens the evidence behind your quality and compliance decisions. Automated, repeatable testing makes results defensible and easier to reproduce during an audit.
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. As more of that maturity curve involves intelligent agents, an AI governance framework and clear oversight become part of staying compliant. Watch the Automated GxP Cloud Compliance session from the USDM Life Sciences Summit to further explore this topic.
The automation maturity curve
- Rule-based automation — scripted, deterministic tasks that remove repetitive manual steps.
- Virtual agents — software that executes structured workflows across systems.
- Cognitive agents — automation that interprets less structured inputs and adapts.
- AI / machine learning — models that surface patterns and insights from large data sets.
At every stage, computer software assurance and continuous validation keep the controls proportional to risk—so automation accelerates quality work instead of introducing new compliance gaps.
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. To keep automated and continuously validated systems healthy over time, pair this approach with disciplined validation lifecycle management. 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.
Resources that might interest you
- Automate Validation Across Your Tech Stack – White Paper
- Data Rich and Information Poor – Blog
- Agile Compliance for High-Quality GxP Software – Blog
FAQ: Manual vs. automated testing in life sciences
Why do manual processes produce more errors?
Manual testing is tedious, so reviewers tend to slip into autopilot and overlook inaccuracies. Reviewers may also lack the knowledge, experience, or tools needed for a given scenario—and as data sets grow, manual review slows the time to discovery and reduces the usefulness of the data.
What does automated testing improve over manual testing?
Automation enables batch testing for quality control, consistent execution every time, regression testing during software development, and the ability to compare large amounts of data in a short period—reducing the variability that drives manual errors.
How does computer software assurance (CSA) fit in?
As organizations advance from rule-based automation toward AI and machine learning, USDM applies computer software assurance to focus testing effort on risk, driving efficiency while keeping systems compliant.
What is continuous validation and how do ProcessX and Cloud Assurance support it?
ProcessX is a fully validated, GxP process automation platform built on the ServiceNow technology stack. Paired with USDM Cloud Assurance, it automates and maintains validation and testing and delivers continuous validation that meets global regulatory requirements beyond U.S. FDA 21 CFR Part 11.
Ready to reduce errors and accelerate compliant testing? Talk with USDM about automating validation and adding continuous compliance to your quality program. Contact us to get started.
