Fractional QA

For short-term additional QA resource or acting QA Manager The Knowlogy is experienced in providing services to GLP facilities and GCP laboratories

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QA Manager

The Knowlogy provides QA Manager services for GLP facilities and GCP laboratories, or where GLP/GCP is a small part of their business.

Typical QA Manager service covers:

  • Regulatory Training

  • Annual Audit Programme development

  • Conduct facility and process audits

  • Perform Study Specific Audits

  • Support/Hosting regulatory inspections

  • Regulatory review of policies and SOPs

  • Owner of QA processes, SOPs, forms and templates

  • Regulatory advice

QA Resource

For a short-term solution, The Knowlogy provides support to GLP facilities and GCP laboratories for

  1. Cover in the absence of the individual QA Manager/Auditor

  2. Backlog in reports

  3. Additional QA resourcing needs

Areas of Experience

The Knowlogy has extensive experience with various types of studies conducted in compliance with GLP and analytical technologies for the analysis of samples from both pre-clinical and clinical trials.

    • Acute, short and long term toxicology

    • Mutagenicity

    • Developmental & Reproductive Toxicology (DART)

    • Pharmacology

    • Metabolism

    • Histopathology

    • Environmental Fate

    • Environmental Toxicology

    • Ecosystems

    • Residue

    • Small/Large molecule LC-MS/MS

    • Flow Cytometry

    • Ligand Binding Assay/Immunoassay

    • PCR

    • LIMS

    • Document Management

    • Analytical Systems

    • In-house solutions

    • Software as a Service

    • Virology

    • Analytical Chemistry

    • Phys.Chem testing

    • Toxicokinetics

    • Archives

    • Statistics

How we work

Cost Efficiency

The Knowlogy will work remotely wherever possible to minimise cost. We will work with your organisation to design solutions to share documents and data electronically.

We will also make suggestions to maximise our time. For many clients, our relationship starts with an independent audit of QA. This provides a benefit of the audit of QA being performed and allows the auditor to familiarise themselves with your organisational processes

Partnership

For effective QA, it is important to understand your organisation, systems and processes. This only comes with building a long-term relationship, which reduces onboarding effort, eliminates repeated knowledge transfer and ensures that QA support is available when you need it.

Continuous Improvement

We recommend establishing a performance framework with clear expectations and measurable KPIs. This creates transparency and keeps everyone aligned.

The Knowlogy is not a ‘tick’ QA service; your organisation will benefit from feedback to improve systems and processes, as well as providing regulatory knowledge.