Compliance Gurus excels in delivering Computer Software Assurance (CSA) and Computer System Validation in the Pharma & Life Sciences industry. Our expertise ensures that computer systems in pharmaceuticals, biotechnology, and medical devices meet stringent regulations, such as the FDA’s 21 CFR Part 11 and global standards. With a focus on quality assurance in pharma software, we safeguard product safety, data integrity, and patient safety.
Computer Software Assurance (CSA)
Our Computer Software Assurance services adopt a risk-based computer software assurance approach, ensuring systems in regulated environments are designed, implemented, and maintained to meet CSA FDA requirements. CSA emphasizes system performance, security, and compliance without excessive documentation, streamlining processes for efficiency without overburdening the process with unnecessary documentation and testing.
Computer System Validation (CSV)
Computer System Validation (CSV) ensures your systems are rigorously tested and verified to perform as intended, complying with regulations like 21 CFR Part 11. CSV in pharma services include detailed documentation, testing protocols, and ongoing monitoring, from system design to operation, ensuring robust quality assurance in pharma software throughout the system lifecycle.
Difference between CSA and CSV: While CSV focuses on comprehensive testing and documentation, CSA leverages a risk-based approach to reduce unnecessary efforts, making it more efficient for CSV vs CSA for medical devices and other regulated systems.
Comprehensive Validation Expertise
Our seasoned validation experts specialize in industry-leading GxP software, including ERP/MRP, e-QMS, LMS, LIMS, REDcap, SAP, Odoo, Oracle Fusion, MES, PLC, SCADA, Fishbowl, Master Control, Trackwise, Veeva, Greenlight Guru, Clinical, Pre-Clinical, DMS, WMS, Delta V, NetSuite, Medrio, DocuSign, NuGenesis, and Syncade. We ensure your systems meet regulatory standards through our CSA & computer system validation in pharma expertise.
Compliance Gurus assesses your Computer System Validation and CSA packages to ensure GxP software applications remain validated throughout their lifecycle. Our validation of SaaS in regulated industries expertise covers cloud-based platforms like Amazon Web Services (AWS), Microsoft Azure, and Google Cloud Platform (GCP), ensuring compliance in IaaS, PaaS, and SaaS environments.
Why Choose Compliance Gurus?
Our team’s fluency in validation of SaaS in regulated industries and cloud infrastructure ensures your systems are audit-ready and compliant. By combining risk-based computer software assurance with traditional CSV in pharma, we deliver tailored solutions that balance compliance with operational efficiency, empowering your organization to thrive in the Life Sciences sector.
Talk With Us to boost your compliance with our CSA & computer system validation in pharma expertise today.
