AN ISO 9001:2015 CERTIFIED
Company Connect Consultancy
Expert Software Validation & Compliance Solutions
Computer System Validation Consulting Services
Company Connect Consultancy (CCC) is a trusted provider of Computer System Validation (CSV) consultancy services, dedicated to helping regulated industries achieve compliance with industry standards and regulatory requirements. Our team of experienced consultants possesses in-depth expertise in the regulatory landscape and industry best practices. We collaborate closely with our clients to develop customized validation strategies that effectively address their unique operational needs and challenges.
Validation Methodologies
V-Model Methodology
Rigorous verification and validation at each development stage, ensuring comprehensive testing coverage and regulatory compliance for critical systems.
Waterfall Methodology
Rigorous verification and validation at each development stage, ensuring comprehensive testing coverage and regulatory compliance for critical systems.
Agile Methodology
Iterative approach enabling rapid delivery while maintaining validation rigor through continuous testing and stakeholder feedback.
Complete Service Portfolio
Comprehensive validation and compliance solutions across all regulatory requirements
Software Categorization & Risk Assessment
GAMP-5 Compliant Classification
Our validation deliverables are precisely tailored based on software category assessment (Categories 3, 4, and 5), ensuring appropriate validation effort and documentation depth for each system's complexity and risk profile.
Software Assessment
Comprehensive evaluation using GAMP-5 guidelines to determine appropriate validation approach
Requirements Analysis
URS, FRS, PRS, and SRS preparation and review ensuring complete system specification coverage
Risk Analysis
FMEA/FMECA methodology implementation for systematic risk identification and mitigation
Source Code Review
Live understanding and comprehensive analysis of system architecture and coding standards
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Strategy Decision
Validation plan development with targeted deliverables based on category and risk assessment
Testing & Validation
Complete STLC implementation with advanced test management tools and defect tracking
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Advanced Testing & Quality Assurance
Comprehensive STLC Implementation
Expert utilization of industry-leading test management platforms including HP ALM, codeBeamer, JIRA with X-ray and Zephyr Scale extensions for complete test lifecycle management.
Test Strategy Development
Risk-based testing approaches aligned with validation requirements and regulatory expectations
Defect Management
Systematic defect lifecycle management ensuring complete traceability and resolution verification
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Comprehensive Reporting
Detailed Test Summary and Validation Summary Reports providing complete validation evidence
Our Services
Our CSV Consultancy Key Features
Compliance Assessment
We conduct a comprehensive assessment of your existing computer systems to identify any gaps in compliance. This assessment involves a thorough review of system documentation, processes, and controls to ensure alignment with regulatory requirements.
Validation Planning and Strategy
Based on the assessment results, we work closely with you to develop a detailed validation plan and strategy. This includes defining validation objectives, scope, deliverables, and timelines. We consider industry standards and regulatory guidelines to ensure a robust and compliant validation process.
Risk Assessment and Mitigation
We assist in identifying potential risks associated with your computer systems and their impact on data integrity, reliability, and security. Our consultants employ risk assessment techniques to prioritize risks and develop effective mitigation strategies, such as risk-based testing and validation approaches.
Standard Operating Procedures (SOPs)
We provide guidance on developing and improving documentation practices, including creating validation protocols, test scripts, and standard operating procedures (SOPs). Well-documented processes and procedures are crucial for demonstrating compliance and ensuring consistent system performance.
Validation Execution
Our experienced consultants oversee the execution of validation activities, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) testing. We guide you through the testing process, ensuring adherence to protocols and best practices.
End-to-End Data Migration Services
We make your data migration stress-free with a clear plan, thorough verification, and detailed reporting. From preparing the right migration strategy to validating data accuracy and delivering transparent reports, we ensure a smooth, secure, and reliable transition for your business.
Operation & Maintenance Services
We ensure your systems run smoothly with reliable operation and proactive maintenance support. From day-to-day system monitoring to preventive maintenance and quick issue resolution, our team helps maximize uptime, extend system life, and keep your business performing at its best.
Change Control Management
We assist in establishing robust change control and deviation management processes for your computer systems. This involves defining change control procedures, documenting change requests, assessing impacts, and implementing appropriate controls to maintain system integrity.
Periodic Reviews
We conduct regular reviews of computerized systems to ensure they remain compliant, validated, and fit for use. Our periodic review services cover documentation checks, system performance, data integrity, and regulatory compliance—helping you identify risks early and maintain continuous validation.
Periodic Reviews
We help organizations safely retire and decommission outdated systems while ensuring data integrity, compliance, and business continuity. Our approach covers planning, data archiving, validation checks, and regulatory documentation—so you can securely transition without risks or data loss.
Ensure Compliance with Confidence
Request a Quote Today!
Partner with Company Connect Consultancy for expert CSV guidance, ensuring the integrity, reliability, and security of your computer systems. Our customer-centric approach helps you meet regulatory requirements while optimizing system performance and efficiency. Contact us today for a no-obligation quote!