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Computerised System Validation Audits, Training & Consultancy

Expert guidance and support to ensure your Computerised System Validation (CSV) processes comply with regulatory requirements, enhance system reliability, and uphold the highest standards of data integrity and operational efficiency.

Services to Support CSV Compliance

At The Knowlogy, we provide comprehensive CSV services to ensure your computerised systems comply with regulatory requirements, enhance efficiency, and maintain data integrity.

Whether you’re implementing a new system or need to validate existing processes, our experts develop a tailored approach to address your unique challenges and support your compliance goals.

GLP Auditing Services

Computerised System Validation (CSV) audits are essential to ensuring your computerised systems comply with regulatory requirements and function reliably to support data integrity and operational efficiency.

Our expert auditors conduct in-depth assessments to evaluate your systems’ adherence to CSV guidelines, identifying gaps and areas for improvement. We provide actionable insights and recommendations to enhance compliance, mitigate risks, and strengthen system reliability.

With a comprehensive range of CSV-compliant audits, including initial validations, periodic reviews, and regulatory inspection readiness assessments, we help you maintain compliance and optimise your digital infrastructure.

  • Computerised System Development Life Cycle (SDLC) Process Audits
  • Computer System Compliance (CSC) Consulting
  • 21 CRF 11 Compliance Gap assessment
  • Development and deployment of CSV processes tailored to your systems
  • Conduct and completion of Computer System Validation
  • Computer System compliance auditing
  • System-specific computer system validation audits
  • Data centers
  • Backup and data recovery
  • Business continuity and disaster recovery
  • IT Security

How We Work

Our structured approach to CSV compliance ensures your computerised systems meet regulatory standards, function reliably, and maintain data integrity. Each step is tailored to your organisation’s specific systems and operational needs for seamless implementation and sustained compliance.

Step 1: System Evaluation and Risk Assessment

We start with a detailed consultation to understand your digital infrastructure, workflows, and compliance status. Our team conducts a CSV risk assessment and gap analysis to identify vulnerabilities and areas for improvement.

Step 2: Tailored Validation Strategy

Based on the assessment, we design a custom CSV validation plan, incorporating best practices for data integrity, system lifecycle management, and documentation. This ensures your systems align with industry regulations and operational requirements.

Step 3: Validation Execution and System Integration

Our experts work alongside your team to implement the validation plan, ensuring that all system processes, security controls, and data management practices are fully compliant. We provide hands-on guidance for documentation, testing, and system integration.

Step 4: Ongoing Compliance Management

With regulations constantly evolving, we offer continuous monitoring, system revalidation, and periodic audits to keep your systems up to date. Our proactive approach helps mitigate risks and ensures long-term regulatory compliance.

  • We highly recommend The Knowlogy for their exceptional service and outstanding QA consultancy.

    Over the past 10 months, we worked with The Knowlogy to set up our GCLP laboratory and validate the method for measuring a primary biomarker.

    Their thorough understanding of our project’s complexity, attention to detail, and clear communication of GCLP requirements were impressive. The team’s professionalism, responsiveness, and technical proficiency helped us enhance our efficiency and effectiveness.

Key Benefits

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Expertise

Our team of certified CSV professionals possesses extensive experience in the laboratory sciences, ensuring a deep understanding of CSV guidelines and regulatory requirements.

Commitment to Quality

We are committed to providing exceptional quality of service, ensuring that your CSV journey is compliant, efficient, and risk-mitigated.

Proven Track Record

We have a proven track record of successfully supporting laboratory teams of all sizes across diverse industries.

Customer-Centric Approach

We prioritise customer satisfaction and value your input throughout every phase of your CSV engagement.

MEET THE TEAM

The Knowlogy will never offer a one-size fits all solution.

As an agile company, we provide bespoke services, from single solutions to comprehensive suites, to support your unique situations.

IMG 4456 Enhanced NR scaled

Cate Ovington

Founder & Managing Director
IMG 4460 Enhanced NR scaled

Stuart Ovington

Company Director
IMG 4506 Enhanced NR scaled

Elaine McLachlan

Quality Consultant

Contact Us

Whether you need support with CSV validation, system audits, training, or customised compliance solutions, our team is here to guide you through every step of the process.

Get in touch with us today to learn how our comprehensive CSV services can help ensure your systems meet regulatory standards and operate with integrity.