Skillbee Solution

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Skillbee Solution

Computerized System Validations
Excellence in IT Infrastructure Qualification

IT Infrastructure Consulting Services

Skillbee Consultancy specializes in thorough validation and testing of enterprise IT infrastructure. Their services ensure compliance, reliability, and optimal performance. They support both on-premises and cloud-based environments, delivering end-to-end quality assurance. By identifying and resolving issues early, they help organizations maintain operational excellence. Their approach is tailored to meet stringent industry standards and evolving business needs.
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Requirements Specification Development

User Requirements Specification

Detailed analysis and documentation of business needs, functional requirements, and user acceptance criteria for infrastructure systems.

Infrastructure Platform Requirements

Technical specifications defining hardware, software, and network requirements for optimal system performance and scalability.

Functional Specification Review

Comprehensive evaluation of system functionality, interface requirements, and operational procedures to ensure complete coverage.

Cloud Infrastructure Qualification

Infrastructure as a Service

IaaS platform validation including compute resources, storage systems, and network configurations across AWS, Azure, and Google Cloud platforms.

Platform as a Service

PaaS environment testing for application deployment platforms, middleware services, and development framework compliance validation.

Software as a Service

SaaS application qualification including user access controls, data integrity verification, and integration testing with existing systems.

Advanced Testing Solutions

Enterprise Test Management

Utilizing industry-leading testing platforms to ensure comprehensive coverage and traceability throughout the validation lifecycle.

​HP Application Lifecycle Management

Integrated testing workflows and requirements traceability

codeBeamer Integration

​End-to-end application lifecycle management and compliance tracking

JIRA Test Management

X-ray and Zephyr Scale plugins for agile testing methodologies

Complete Service Portfolio

Comprehensive validation and compliance solutions across all regulatory requirements
  • 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

Defect Management & Reporting

Comprehensive Defect Tracking

Advanced defect management workflows ensure rapid identification, categorization, and resolution of system issues while maintaining detailed audit trails.

  • Real-time defect classification
  • Priority-based escalation workflows
  • Root cause analysis documentation

Test & Qualification Reports

​Detailed summary reports providing complete validation evidence, compliance documentation, and recommendations for system approval and deployment.

  • Executive summary dashboards
  • Detailed technical findings
  • Regulatory compliance verificatio

PLC Validation & Business Continuity

PLC System Validation

Comprehensive testing of programmable logic controllers ensuring manufacturing system reliability and regulatory compliance in industrial environments.

Disaster Recovery Planning

Comprehensive testing of programmable logic controllers ensuring manufacturing system reliability and regulatory compliance in industrial environments.

IT Resilience Framework

Comprehensive testing of programmable logic controllers ensuring manufacturing system reliability and regulatory compliance in industrial environments.

Operations & Maintenance Services

System Operations

24/7 monitoring and maintenance ensuring optimal performance and availability of validated infrastructure systems.

System Decommissioning

Controlled retirement procedures ensuring data security and regulatory compliance during infrastructure transitions.

IT Resilience Framework

Comprehensive testing of programmable logic controllers ensuring manufacturing system reliability and regulatory compliance in industrial environments.

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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