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GCLP Audits, Training & Consultancy

Expert guidance and support to ensure your Good Clinical Laboratory Practice (GCLP) compliance aligns with regulatory requirements, enhances efficiency, and upholds the highest quality standards in clinical research and laboratory testing.

Services to Support GCLP Compliance

At The Knowlogy, we provide comprehensive GCLP services to help your laboratory maintain regulatory compliance, optimise workflows, and ensure the integrity of clinical research data.

Whether you’re launching a new study or need ongoing compliance support, our experts offer tailored solutions to meet the unique challenges of your clinical laboratory.

GCLP Auditing Services

The Knowlogy offer comprehensive GCLP auditing services to help you maintain compliance and protect the integrity of your research.

The GCLP team provides services for laboratories that analyse samples from clinical trials for safety parameters, small and large molecules, biomarkers, and other specialty bioanalysis.

  • Facility Audits
  • Study Audits
  • Analytical Plan Audits
  • Data Audits
  • Procedure/ Process Audits
  • Report Audits
  • Archive Audits
  • Qualification or requalification audits
  • Mock Inspections
  • Document Reviews
  • Subcontractor and vendor inspections
  • Quality System development and deployment
  • Inspection Readiness
  • QA Manager
  • Quality System Assessment / Gap Analysis
  • Expert advisory support

How We Work

We work specifically to your individual GCLP requirements, utilising an approach that is structured, with actionable steps to implement and adhere to GCLP standards.

Step 1: Initial Consultation and Assessment

Starting with a thorough consultation, we assess your lab’s needs and existing practices. Our team performs a GCLP gap analysis to pinpoint areas for improvement, ensuring alignment with current GCLP standards.

Step 2: Customised GCLP Compliance Strategy

After the assessment, we develop a customised GCLP compliance strategy to address your lab’s unique challenges and objectives. We recommend actions for training and process optimisation, ensuring alignment with industry best practices.

Step 3: Implementation and Support

In collaboration with your team, we implement the strategies to ensure that all procedures, protocols, and documentation comply with GCLP requirements, offering hands-on support for a smooth transition and full compliance.

Step 4: Continuous Monitoring and Auditing

As GCLP compliance is an ongoing process, we provide continuous monitoring and auditing services to help your lab maintain compliance and stay ahead of regulatory changes.

  • 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 GCLP professionals possesses extensive experience in the laboratory sciences, ensuring a deep understanding of GCLP guidelines and regulatory requirements.

Commitment to Quality

We are committed to providing exceptional quality of service, ensuring that your GCLP 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 GCLP 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.

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Cate Ovington

Founder & Managing Director
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Stuart Ovington

Company Director
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Elaine McLachlan

Quality Consultant

Contact Us

Whether you need assistance with GLP audits, training, consulting, or tailored solutions, our team is here to support your compliance journey.

Get in touch with us today to discuss how our comprehensive GLP services can benefit your lab.