Quality Assurance Support

Tower Mains prides itself on offering flexible, credible and cost-effective quality assurance unit support services. We provide QA resource when and where you need it – from short ad hoc projects to long term QA collaborations across the regulatory and non-regulatory field.

GLP

Independent audits are beneficial in assuring clients that work is being performed in accordance with their expectations and requirements. To support this, Tower Mains provides audit services on a study and non-study specific basis. For example:

  • Study based Audits

    • Study plan and amendment review
    • Critical phase inspections
    • Raw data and report audit
  • Process Based Inspections
  • Facility Based Inspection

    • A facility Inspection should be carried out on at least an annual basis to ensure continuing compliance with GLP and the requirements of Company SOPs. It should look at the entire organisation, specifically those aspects of which are not covered in the study or process inspections.
    • Independent Audit of your QA Unit
  • Computerised System Validation Audits

    • Validation plan review
    • SRS / SCS review
    • Test script review
    • Report audit
  • QMS Documentation Support

    • SOPs
    • Policies
    • Standard forms, templates and spreadsheets
  • Ad hoc consultancy Services

    • General advice and support on Quality Assurance and Regulatory matters

Our team supporting GLP organisations have experience in the following areas:

  • Toxicology
  • Genetic Toxicology
  • Developmental and Reproductive Toxicology (DART)
  • Bioanalytical

  • Pharmacokinetic/Toxicokinetic

  • Metabolism

  • Immunohistochemistry

  • Field Trials

  • Ecotoxicology

  • Environmental Fate & Metabolism

  • Residue studies

  • Biocidal Products

  • ISO 10993

GMP

QA support options available include:

  • Routine QS activities

    • CAPA management, investigation co-ordination, document control
  • Internal Audits

    • Internal audits are a critical part of any QS, carried out to an annual schedule to ensure continuing compliance with the system and regulation. They should look at the entire organisation. Tower Mains can assist with the planning, conduct and review of these audits as applicable.
  • Regulatory and Vendor Audits

    • Tower Mains can also provide support in preparation for and hosting Regulatory audits and conduct of Vendor audits as well as being involved in the vendor management process. These additional activities include:
      • Attendance at Regulatory Inspections
      • Audit of Critical Subcontractors and vendors
      • Document Reviews
      • Assisting with responses to external audit reports

GCP

In addition to Audits, QA support options include but are not limited to:

  • Clinical Quality Systems Development

    • Production, review, and advice on quality documents (SOPs, Policies, templates)

  • Corrective and Preventive Actions (CAPA) Review and Support

    • Team training on CAPA and root cause analysis understanding
    • MHRA Inspection, internal, and sponsor CAPAs support

  • Investigator Site Support and Advice

  • Ad hoc Quality Assurance Support

  • Inspection Readiness

    • Mock Inspections, including interviews with those likely to be interviewed by regulators
    • General Inspection readiness for sponsors, NHS trial units and Clinical Research Organisations
    • Review of GCP dossiers to be submitted to regulatory authorities, for example, the MHRA
    • Trial Master File (TMF) Inspection readiness

Discuss Your Quality Assurance Requirements

Contact Us Today