Automated Software Validation for Life Sciences
Speed up compliance. Eliminate manual effort. Stay audit-ready with SIMCO’s automated validation service.
In the life sciences industry, software systems are essential for ensuring product quality, patient safety, and regulatory compliance. Systems like QMS, LIMS, MES, and ERP manage critical processes, so they must be validated to prove they function as intended. Without proper validation, companies face compliance risks, audit issues, and potential product failures.
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Manual Validation Is Costly, Slow, and Risky
Traditional software validation in life sciences demands significant time and resources, often resulting in delays and inefficiencies. As regulatory expectations grow, manual methods struggle to keep pace and expose organizations to increased compliance risk.
- Test execution requires heavy manual effort, slowing down validation cycles
- Errors and rework are common, raising the chance of audit findings
- Managing frequent updates and documentation overwhelms internal teams
Power Your Validation Plan with Automated Test Execution
SIMCO’s Automated Software Validation focuses on the critical phase of test case execution, transforming a traditionally manual and time-consuming task into an efficient, automated process. This stage of the validation plan involves running predefined test scripts to confirm that software performs as intended under regulatory guidelines. By automating execution, SIMCO reduces test execution time by 93%, eliminates human error, and produces detailed, audit-ready documentation with every run.
- Executes test cases based on your defined requirements and risk assessments, maintaining alignment with upstream validation inputs
- Delivers comprehensive, structured results that support clear and compliant documentation
- Enables faster, easier validation for future software updates, thanks to reusable automated test scripts
Key Benefits of Automated Software Validation
SIMCO’s Automated Software Validation delivers speed, consistency, and confidence to life sciences teams managing complex compliance demands. By replacing manual processes with intelligent automation, SIMCO helps organizations validate critical systems faster, reduce risk, and maintain a fully documented, audit-ready state across every software update.
- Reduce Validation Time by 93%: Automation eliminates manual effort and dramatically shortens validation cycles
- Optimize Workflow PQ: Leverage independent expertise to validate customized business workflow Performance Qualifications (PQ)
- Complete Documentation: Receive fully structured, standards-compliant validation documents for every test cycle
Validation You Can Trust and Proof You Can Show
SIMCO’s Automated Software Validation accelerates the validation process while delivering the structured, reliable documentation required for compliance. Each test cycle produces a complete set of records that meet regulatory expectations and support both internal quality efforts and external audits. With documentation that is clear, consistent, and audit-ready, your team gains confidence and control over every phase of software validation.
- Auditor-Friendly Summary Reports: High-level pass/fail results with digital signatures for quick review
- Detailed Execution Reports for Internal Teams: Step-by-step test documentation with screenshots and video evidence to support internal review and traceability
- Reusable Test Scripts: Automated scripts are stored and ready for rapid re-validation during future software updates
Complete Documentation Support from Validation Professionals
In addition to automated test execution, SIMCO offers comprehensive Validation Documentation Creation Services to support every phase of your software validation process. Backed by decades of experience in regulated industries, our validation experts bring deep knowledge of compliance requirements and industry best practices. We provide the regulatory expertise and structured documentation needed to build a complete, compliant, and audit-ready validation package.
SIMCO provides expert development of:
- User Requirements Specifications (URS)
- Risk Assessments
- Test Cases
- Traceability Matrices