VALIDATION & COMPLIANCE

Building a Foundation for Operational Integrity

Our specialized validation and compliance services help your lab meet legal standards, avoid risks, and establish reliable, audit-ready processes that support long-term success.
WAY FORWARD

Addressing Your Biggest Compliance Challenges

CSols’ expertise safeguards your operations against these risks, providing solutions that optimize compliant workflows and support ongoing regulatory alignment, even as Computer System Validation (CSV) transitions to Computer Software Assurance (CSA).
Merging Technologies
We help integrate systems during mergers and acquisitions to meet industry standards.
Managing Complex Challenges
We create and oversee validation plans that address complex regulatory challenges, helping you simplify processes and maintain alignment with standards.
Meeting Regulatory Demands
If your current LIMS, CDS, QMS, MES, and LMS no longer meet regulatory frameworks, we help you upgrade to a compliant system so you can focus on growth.
Closing Gaps
We identify and resolve issues, keeping your lab prepared for audits and inspections.
OUR APPROACH

Our Approach to Reliable Validation

Our approach to compliance combines industry expertise, rigorous risk-based validation processes, and a commitment to maintaining standards.
Custom Regulatory Strategy
We develop comprehensive strategies tailored to your labs’ needs, addressing standards like FDA, ISO, and GMP. Our proactive approach helps you stay ahead of changing requirements and avoid costly penalties.
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Computer System Validation Planning
At CSols Inc, we design detailed validation plans that support system implementation while helping you meet industry benchmarks. We back up these efforts with testing and documentation processes to provide a clear path for regulatory approvals and audits.
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Comprehensive IQ, OQ, and PQ Validation
At CSols, validation goes beyond documentation—we create, execute, and support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) scripts to ensure your systems meet regulatory expectations.
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Risk-Based Assessment
CSols has always taken a risk-based approach to system validation, so that regardless of whether the CSV or CSA methodology is applied, you receive a system that is fit for purpose and audit ready.
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Resource Optimization
Our team helps you allocate resources efficiently across projects to make the most of your time, budget, and technology investments. This approach reduces waste and maximizes productivity.
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THE CSOLS ADVANTAGE

Maintain Operational Integrity & Compliance

CSols is vendor agnostic and has a dedicated validation team separate from our technical team but with reachback access for support. This dedicated team with deep expertise allows for more cost-effective validation processes and proven successful completion of 120 + validation projects
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