AN ISO 9001:2015 CERTIFIED
Company Connect Consultancy – Excellence in Validation
Excel sheet validation Consulting Services
At Company Connect Consultancy, we specialize in comprehensive validation and testing of enterprise IT infrastructure—including Excel-based systems—to ensure full compliance with FDA 21 CFR Part 11 and EU Annex 11 regulations. Our services are designed for the pharmaceutical and medical device industries, ensuring data integrity, reliability, and regulatory readiness. Whether operating in physical or cloud environments, we help organizations achieve operational excellence through robust, compliant solutions.
SDLC Methodologies for Validation Excellence
V-Model Approach
Structured validation methodology ensuring each development phase has corresponding testing activities for comprehensive quality assurance.
Waterfall Validation
​Traditional sequential approach ideal for highly regulated environments requiring extensive documentation and phase-gate approvals.​
Strategic Validation Deliverables
Category-Based Decision Framework
Our validation approach varies based on GAMP-5 categorization. Category 3 systems require basic validation, Category 4 demands comprehensive testing protocols, while Category 5 necessitates full lifecycle validation with extensive documentation.
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•Category 3: Commercial off-the-shelf software
•Category 4: Configured systems with customization
•Category 5: Custom-developed applications
Regulatory Compliance Assessment
21 CFR Part 11 Compliance
​Comprehensive assessment of electronic records and signatures requirements, ensuring data integrity and audit trail compliance for FDA-regulated environments.
EU Annex 11 Evaluation
European regulatory framework assessment covering computerized systems validation, focusing on risk-based approaches and lifecycle maintenance requirements.
GAMP-5 Spreadsheet Initial Assessment
Initial Assessment
Evaluate spreadsheet complexity, business impact, and regulatory requirements to determine appropriate GAMP-5 category classification.
Category Assignment
Assign final GAMP-5 category based on assessment results, determining validation scope and documentation requirements accordingly.
Risk Analysis
Conduct thorough risk assessment considering patient safety, product quality, and data integrity implications of the Excel application.
Validation Strategy
Develop tailored validation approach based on assigned category, ensuring proportionate effort and regulatory compliance alignment.
Risk Management Excellence
FMEA & FMECA Methodologies
Systematic risk assessment using Failure Mode and Effects Analysis (FMEA) and Failure Mode, Effects, and Criticality Analysis (FMECA) to identify potential system failures and implement preventive measures.
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Identify potential failure modes in Excel calculations and data processing​
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Assess impact severity and occurrence probability for each failure mode​
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​Implement risk mitigation strategies and control measures
Validation Planning & Strategy
Validation Plan Development
​Comprehensive validation plans tailored to your Excel application's complexity and regulatory requirements, defining scope, approach, and acceptance criteria.
Strategic Decision Making
Expert guidance on validation strategy selection, balancing regulatory compliance requirements with business needs and resource constraints.
Implementation Roadmap
Detailed project timeline with milestones, deliverables, and resource allocation to ensure successful validation execution within budget and schedule.
Requirements Documentation Excellence
User Requirements Specification (URS)
Detailed documentation of business needs, functional requirements, and regulatory constraints for your Excel-based system validation.
Design Specification (DS)
Technical specifications defining system behavior, performance criteria, and interface requirements to support validation activities.
Our experienced team prepares comprehensive requirements documentation or provides thorough reviews of existing specifications to ensure completeness and regulatory alignment.
Advanced Testing & Quality Management
Test Management Platforms
​Expertise with industry-leading tools including HPALM, codeBeamer, and JIRA extensions like X-ray and Zephyr Scale for comprehensive test lifecycle management.
Defect Management
Systematic defect identification, tracking, and resolution processes ensuring thorough issue management throughout the validation lifecycle.
STLC Implementation
Complete Software Testing Lifecycle execution from test planning through closure, ensuring comprehensive coverage and quality assurance.
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!