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Solutions · Quality Assurance | GCP Audits, Inspection Readiness | Guosa Life Sciences

Quality That Inspires Confidence

Embedding Quality Throughout the Lifecycle

Quality is not a checkpoint at the end of a study. It is a continuous discipline underpinning every decision, process and outcome. As trials become increasingly global and complex, sponsors require quality systems that extend beyond compliance to support proactive risk management, continuous improvement and inspection readiness.

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Home/Solutions/Quality Assurance | GCP Audits, Inspection Readiness | Guosa Life Sciences

Overview

Embedding Quality Throughout the Lifecycle

Guosa Life Sciences delivers Quality Assurance solutions integrating governance, risk-based quality management, auditing, inspection readiness and vendor oversight into every phase.

Our objective is to help sponsors build confidence in their data, processes and partnerships while protecting participant safety and maintaining compliance.

Capabilities

What We Deliver

Audits and Readiness

GCP audits
Vendor audits
Inspection readiness
Mock inspections
Document and TMF review

Systems and Improvement

CAPA management
Risk-based quality management
Quality management systems
Compliance oversight
Quality metrics

The GLS Advantage

Strengthened by the Whole Enterprise

Every solution delivered by Guosa Life Sciences is strengthened by the broader enterprise. Our operational teams are supported by evidence-based Insights, professional development through GLS Academy, collaborative partnerships within the Clinical Development Network and a quality-driven delivery model, enabling scientifically sound, operationally efficient and scalable solutions.

Explore the Enterprise

Evidence-based Insights
GLS Academy development
Clinical Development Network
Integrated quality systems
Technology-enabled delivery
Global operational reach

The capability

What We Actually Do

We audit, remediate and prepare. That means GCP audits of sites, vendors and systems, trial master file quality oversight, CAPA management, data integrity assessment against ALCOA+ expectations, and inspection readiness programs that rehearse the inspection rather than describe it.

Remediation work is a distinct discipline from routine auditing, and we treat it as one. Where a program arrives with an incomplete TMF, unresolved deviations or a quality system that exists on paper but not in practice, the first deliverable is an honest gap assessment with a sequenced remediation plan and a realistic timeline. Sponsors are usually better served by knowing the true position early than by a reassuring first report.

Regulatory considerations

E6(R3) quality management systems and inspection readiness

ICH E6(R3) makes the quality management system the organizing structure rather than an adjacent function. The principles and Annex 1 took effect on 23 July 2025, and Annex 2 follows on 15 January 2027. Inspectors now expect to see critical-to-quality factors identified in the protocol, risks assessed and documented, and evidence that the monitoring approach followed from that assessment.

This changes what inspection readiness means in practice. It is no longer sufficient to demonstrate that SOPs exist and training was completed. The question is whether quality decisions were made deliberately, recorded at the time, and traceable afterward. Programs that adopted risk-based approaches after 2020 often already work this way; what is frequently missing is the documentation that proves it. We concentrate on closing that gap before an inspector finds it.

How an engagement runs

The Sequence

1. Gap assessment

An evidence-based review of the quality system, TMF, deviations and vendor oversight against E6(R3) expectations, with findings ranked by inspection risk.

2. Remediation planning

A sequenced plan with owners and realistic dates, distinguishing what must be fixed before an inspection from what can follow.

3. Execution and audit

Audits conducted, CAPAs raised and tracked to closure, TMF reconciled, training refreshed where the gap is competence rather than documentation.

4. Inspection readiness

Mock inspection with interview rehearsal, storyboard preparation and a defined response process for the day itself.

What you receive

Deliverables

A ranked gap assessment against E6(R3). A sequenced remediation plan with owners and dates. Audit reports and a tracked CAPA log. A mock inspection report and inspection response process.

Evidence and context

The Research Behind This Work

Our operating assumptions are published rather than asserted. The Future of Clinical Trials in Africa sets out why study performance is increasingly determined by ecosystem maturity rather than site selection, and The Untapped Advantage makes the case that institutions, not regions, are the right unit of qualification. Both are available in full, with executive briefs for readers who want the argument in a shorter form.

The Future of Clinical Trials in Africa The Untapped Advantage

Clinical Operations

Quality-driven delivery.

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Regulatory Affairs

Compliance and submissions.

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GLS Academy

Quality leadership training.

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Pharmacovigilance

Safety compliance.

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FAQ

Common Questions

Can you prepare our sites for inspection?

Yes. We deliver inspection readiness assessments, mock inspections and CAPA support to prepare sites, vendors and sponsors for regulatory inspections.

Do you support risk-based quality management?

Yes. RBQM is central to our approach, focusing quality effort where risk to participants and data integrity is greatest.

Let's Discuss Your Program

Tell us about your objectives and our multidisciplinary team will scope an integrated, flexible solution.

Submit an RFP

Quality That Inspires Confidence

Embedding Quality Throughout the Lifecycle

What We Deliver

Audits and Readiness

Systems and Improvement

Strengthened by the Whole Enterprise

What We Actually Do

E6(R3) quality management systems and inspection readiness

The Sequence

1. Gap assessment

2. Remediation planning

3. Execution and audit

4. Inspection readiness

Deliverables

The Research Behind This Work

Explore Related Capabilities

Clinical Operations

Regulatory Affairs

GLS Academy

Pharmacovigilance

Common Questions

Let's Discuss Your Program