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Compliance and Validation simplified

Simplify audits, accelerate qualification, and meet global regulatory standards with confidence. OneSource takes care of compliance so your lab can move faster.

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Compliance is complex. We make it simple.

Common Challenges

  • x Regulatory standards keep evolving and getting stricter

  • x Audit prep takes time away from core scientific work

  • x Paper-based qualification slows down reviews

  • x Inconsistent protocols across vendors and sites

  • x Small errors create big risks for data integrity and compliance

Our Solution

  • ✔ Services designed to meet US, EU, and global regulatory requirements

  • ✔ Part 11-ready reports and automated workflows reduce admin time

  • ✔ Smart, digital documentation that simplifies reviews and approvals

  • ✔ Harmonized protocols across all major instrument types and vendors

  • ✔ Standardized, validated processes that reduce risk and ensure audit readiness

What You Get with OneSource Compliance & Validation

Effortless Qualification

Vendor-neutral IQ/OQ/PQ protocols with built-in automation and audit-ready reports.

Data Integrity by Design

Ensure your systems, workflows, and records align with ALCOA+, 21 CFR Part 11, and Annex 11.

Validation as a Service

We handle CSV, method validation, and remediation so you don’t have to.

 

Compliance That Moves with Your Lab

OneSource Compliance & Validation services support your lab at every stage. From the first installation through every audit, upgrade, and process change. Whether you're qualifying instruments, validating software, or strengthening data integrity, we help ensure nothing slows your lab down.  

Standardized, validated and completely vendor-agnostic▼

 

Turn your data into your strongest asset▼

 

Digital-first qualification for every instrument, every brand ▼

 

Validated systems that pass every audit▼

 

Let Us Help You Make Compliance Effortless

From single-instrument IQ/OQs to full-lab validation programs, OneSource gives you the tools (and the team) to stay compliant and move faster.


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Resources

Universal documentation - An Innovation in Laboratory Compliance

The time and resources needed to meet global requirements for regulatory inspections and remaining compliant are at odds with laboratories’ needs to increase productivity and reduce operating costs.

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Understanding Your Data Integrity and Computer System Validation Needs in the Pre-Clinical Development Laboratory

Pharmaceutical and life sciences companies now face heightened scrutiny over their practices in documenting their electronic processes in particular, and in managing that data across its entire lifecycle.

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Data Integrity is at the Heart of Laboratory Compliance

“Prove It,” Regulators Say Walter Deming, the legendary physicist and management consultant, once described research this way: “Uncertainty makes research predictable, but you still need proof to satisfy everyone else1.”

Learn More