Skillbee Solution

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Skillbee Solution

Computerized System Validations
Excellence in Excel sheet Validation

Excel sheet validation Consulting Services

Skillbee 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.
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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.

  • Category 3: Commercial off-the-shelf software (excelsheet)
  • Category 4: Configured systems (excelsheet)
  • Category 5: Custom-developed applications (excelsheet)

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.

  • Identify potential failure modes in Excel calculations and data processing​
  • Assess impact severity and occurrence probability for each failure mode​
  • ​Implement risk mitigation strategies and control measures
  • Validation Plan Preparation and Strategy Decision
  • Validation using V-Model
  • Validation Deliverables approach based on Software Category (Cat 3
  • Medical Devices & Software as Medical Devices (FDA & EU) Validation
  • ERES 21 CFR Part 11 / EU Annex 11 Checklist Assessment
  • Software Categorization per GAMP-5 Guidelines
  • Computer Software Assurance (CSAI Approach
  • Risk Management using FMEA and FMECA Methodology
  • Preparation and Review of URS/FRS/PRS/SRS
  • Source Code Review Report (Live Understanding)
  • Test Summary Report and Validation Summary Report
  • Software Testing Lifecycle (STLC) Management
  • Testing using HPALM. codeBeamer., JIRA (X-ray. Zephyr Scale)
  • Defect Management Tools Handling
  • PLC Validation
  • Cloud Computing (IaasS. Paas, Saas) Validation Approach
  • Disaster Recovery and Business Continity Planning
  • IT Resilience Plan Preparation and Review
  • Data Migration from Onpremise to Cloud
  • Software Operation and Maintenance
  • Periodic Review of Software Systems
  • Decommissioning of Software
  • Data Migration from Onie System to Another

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.

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 Servicesv

Analytical Instruments CSV

Computerized System Validation and Instrument Qualification of HPLC, GC, UV, IR, Stability Chamber and various Other Instruments of Regulatory Industries Laboratories.Analytical instruments are precision devices used to measure, identify, and quantify chemical, physical, or biological properties of materials, ensuring accuracy, quality control, and compliance in laboratory and industrial applications.

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Enterprise Solutions

We provide end-to-end validation of SAP, Manufacturing Execution Systems (MES), and Data Acquisition Systems (DAS) to support both manufacturing and quality operations across the enterprise. Our services ensure compliance, data integrity, and seamless integration—helping your organization achieve efficiency, reliability, and regulatory readiness.

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LIMS & Stability Management

We deliver validation and support for Laboratory Information Management Systems (LIMS) and Stability Management solutions to streamline lab workflows, ensure data integrity, and maintain regulatory compliance. Our services help manage samples, stability studies, and reporting with accuracy, efficiency, and transparency.

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US & EU Serialization Systems

We provide validation and support for US and EU Serialization Systems to help you meet global regulatory requirements and protect product integrity. Our services ensure secure product tracking, compliance with DSCSA and EU FMD regulations, and end-to-end supply chain transparency.

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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.

Compliance Assessment

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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.

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.

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.

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.

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.

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!
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