Regulatory Consulting

Quality Management System - Working with Leading Global Regulatory Bodies

At PeploBio we are committed to operating as a centre of excellence and establishing productive customer relationships. Quality is at the heart of everything we do, derived by our SOP-driven processes, we abide by strict protocols that manage and streamline our operational processes. Our high-quality standards are further highlighted in Life Sciences Reviews listing PeploBio as one of the Top 5 clinical laboratories in 2022.

Contents

Services

Quality Management System

Our QMS sustains our entire infrastructure from all levels­:

  • GDPR-Compliant (Data Protection and Privacy)

  • Commercial Strategy

  • Operational Procedure

  • Clinical Research

  • Sample Procurement

  • Screening Services

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Protocols & Operational Processes

All operational activities are performed by highly qualified and trained personnel and recorded in controlled documents such as study work plans, Standard Operating Procedures (SOP), and standardised study plans & proposals. All documents are approved by highly qualified personnel before exchanging with a client.

  • Process and Assay Validation & Development

  • Sample Management and Tracking Procedures

  • Comprehensive Study Plans

    This describing all aspects of the study design; regulatory compliance, methodology, data, acquisition, analysis, and reporting will be provided prior to study initiation.

  • Quality Control Checks

    Our strict internal audits ensure both our facilities and personnel meet the highest standards.

  • Data Analysis & Reporting

    Our Laboratory Information Management System (LIMS) streamlines our workflow, offering various tailored data formatting, and methodology to suit a client's requirements.

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Our Facility & Personnel

All documented procedures, study plans and proposal are drafted and approved by personnel with PhD & HCPC registered scientists and are subsequently archived as controlled documents.

  • SOP Generation & Control

    Clearly outlined documents for all levels of our business from commercial strategy, operational activity, and sample procurement, which are continually reviewed and updated accordingly as we identify opportunities to improve.

  • Employee Training & Competency Assessment

    Tiered assessment grading (1-4) to track employee development.

  • Environmental Monitoring

    Written opening and closing procedures for our facility, with information on temperature regulation & monitoring, and laboratory clean-up.

  • Equipment and Instrument Maintenance & Verification

    All our state-of-the-art technologies are regularly maintained, and quality checked to ensure they are fit for purpose.

  • Sample/Specimen Control

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IT Infrastructure

We are an ICO registered organisation with clearly defined data privacy policies, and robust data protection systems to ensure third party patient data remains protected. Read about our policies here.

  • SOP Generation & Control

    Clearly outlined documents for all levels of our business from commercial strategy, operational activity, and sample procurement, which are continually reviewed and updated accordingly as we identify opportunities to improve.

  • Employee Training & Competency Assessment

    Tiered assessment grading (1-4) to track employee development.

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Quality Control & Assurance

To ensure our standards are continuously met, internal audits are performed on a bi-weekly basis to ensure we are abiding by the GLP regulatory requirements stipulated by our international awarding bodies. The objective of QA audits is to monitor the performance of our laboratory services, through doing so, we can optimise the experience for our customers.

  • Good Lab Practice (GLP)

    Training, Support & Assessment to ensure high standards are maintained.

  • Internal Audits

    Comprehensive QA audit reports are generated for all aspects of our business, which are archived to monitor progression.

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What does our QMS Verify?

  • Impartiality

    Verified by a global body to be unbiased and acting fairly in operational discoveries.

  • Integrity

    Our infrastructure and SOP-driven systems control our activities to ensure the needs and expectations of our customers are upheld.

  • Capability

    Full transparency on what we can provide as a medical laboratory, and leading clinical research organisation.

More about QMS

FAQ

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GDPR-Compliant

We are ICO registered organisation with clearly defined data privacy policies, and robust data protection systems to ensure third party patient data remains protected.