Skillbee offers comprehensive Software System Qualification and Compliance Consulting Services, helping organizations ensure their digital systems meet regulatory, quality, and performance standards. Our experts provide end-to-end support — from risk assessment and documentation to validation strategy and audit readiness — ensuring every process aligns with industry norms and enhances operational efficiency and data integrity.
Rigorous verification and validation at each development stage, ensuring comprehensive testing coverage and regulatory compliance for critical systems.
Rigorous verification and validation at each development stage, ensuring comprehensive testing coverage and regulatory compliance for critical systems.
Iterative approach enabling rapid delivery while maintaining validation rigor through continuous testing and stakeholder feedback.
Comprehensive validation and compliance solutions across all regulatory requirements
Our qualification outputs are meticulously customized according to software classification analysis (Classes 3, 4, and 5), guaranteeing the right level of verification effort and documentation detail aligned with each system’s complexity and risk level.
Comprehensive evaluation using GAMP-5 guidelines to determine appropriate validation approach
Comprehensive evaluation using GAMP-5 guidelines to determine appropriate validation approach
Comprehensive evaluation using GAMP-5 guidelines to determine appropriate validation approach
Comprehensive evaluation using GAMP-5 guidelines to determine appropriate validation approach
Comprehensive evaluation using GAMP-5 guidelines to determine appropriate validation approach
Comprehensive evaluation using GAMP-5 guidelines to determine appropriate validation approach
Risk-based testing approaches aligned with validation requirements and regulatory expectations
Systematic defect lifecycle management ensuring complete traceability and resolution verification
Detailed Test Summary and Validation Summary Reports providing complete validation evidence
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.
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.
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.
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.
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.
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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.
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.
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.
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.
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.
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.
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.
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.
