Phase-Appropriate PQS for a Clinical Biotech Sponsor

Building a Phase-Appropriate PQS for a Phase I Clinical Biotech Sponsor

A clinical-stage sponsor, a compressed dosing timeline, and a GMP/GCP quality system built to scale and support investor due diligence inspection.

  • Client: Clinical-stage pharmaceutical biotechnology sponsor headquartered in Australia

  • Sector: Biotechnology, clinical-stage drug development

  • Project type: Phase-appropriate PQS build, GMP/GCP compliance support, SharePoint DMS architecture and legacy data migration

  • Standards: ICH E6(R2) GCP • GMP • GDocP / Data Integrity • 21 CFR Part 11-aligned e-signatures

  • Outcome: Two-stage QMS Go-Live delivered on schedule ahead of the client's Phase 1 trial, with QSN retained for ongoing QA and compliance support

The Challenge

Our client was moving from research and development into their first Phase 1 clinical trial, with a hard external deadline: initial dosing was locked in for mid-February, followed by a multiple-ascending-dose (MAD) trial in May. Good Manufacturing Practice, Good Clinical Practice and data integrity requirements now applied to a business that had, until that point, run on ad hoc file storage and no formal quality management system.

The client's legacy documents sat in Box — thousands of R&D-era files in deep, inconsistent folders, unsuited to controlled document management and impossible to defend to an auditor. Setting up a fully commercial-grade eQMS platform would have been overbuilt and unaffordable for a small Phase 1 team; doing nothing would have left dosing without a compliant quality system behind it. QSN needed to deliver a right-sized, GMP phase-appropriate PQS and document management system that could be trusted for GMP/GCP purposes immediately, and scale cleanly into Phase 2, Phase 3 and beyond.

Our Approach

QSN worked directly within the client's own SharePoint tenant, embedding PQS design, document control and quality risk management around the client's existing development timetable rather than asking the client to work around ours.

Document Management System Architecture

  • Assessed platform options — continuing with Box, a traditional SharePoint folder structure, a metadata-driven SharePoint design, and commercial eQMS packages — and recommended a metadata-driven SharePoint build as the best balance of Phase 1 compliance, cost and future scalability.

  • Proposed a multi-site SharePoint architecture segmented by business area (Corporate, GMP, CMC, Clinical, Regulatory, Toxicology) - the client subsequently took the build of those wider business-area sites in-house, so QSN's delivery focused on the PQS site itself.

  • Built the PQS site directly within the client's SharePoint tenant — document libraries for PQS procedures, QA-only secure records management, risk management, batch records, vendor management, investigations and CAPA, validation and training, each with its own metadata columns, view filters and access permissions.

  • Developed a multi-library, metadata-driven structure that goes well beyond how most clients use SharePoint (typically as a plain file manager), giving the PQS library searchable, reportable structure. The metadata itself was not intended or asserted as 21 CFR Part 11-compliant, so procedural and access controls were layered over the critical GMP libraries to maintain compliance.

  • Developed a risk-based, tiered legacy data migration strategy, selectively migrating only documents critical to Phase 1 and CMC readiness while the remainder was managed by the client with other SP sites, keeping the new PQS clean and audit-ready

Phase-Appropriate PQS Implementation

  • Delivered a two-stage PQS Go-Live aligned to the client's trial timetable — a Soft Go-Live covering select critical processes immediately ahead of initial Phase 1 dosing, and a Full Go-Live covering the remaining core PQS documents ahead of the next trial stage.

  • Built PQS document bundles — SOP, register trackers and associated forms, instructions and templates — across document management, data integrity/GDocP, training, vendor management, change control, quality risk management, deviations, CAPA, audits, quality agreements, management review, validation and batch management.

  • Drafted documents to meet both Phase 1 and Phase 2 compliance expectations where possible, reducing the need for early rework as the program matured.

  • Developed a bespoke digital signature and electronic master-forms process with SP and Adobe — a new approach for QSN, built specifically for this project. Individual digital signatures were configured and logged for authorised staff, and signed PQS documents were converted into fillable Adobe PDF "master" forms with in-built fields, then published as templates within the PQS SharePoint site so staff could generate the current version of any form directly from the site's new-item menu. For multi-stage sign-off documents such as change control, the process let each stage be digitally signed and locked while the remaining sections of the form stayed open for the next signatory.

  • This digital signature workflow is not fully 21 CFR Part 11 compliant — full compliance would require the client to upgrade to Adobe's validated Part 11 tier. The client made an informed decision not to upgrade at this stage.

  • Delivered classroom and online training — including SP PQS site induction, data integrity/GDocP and coordinated Read & Understand training for every issued document across both soft and full go-live events.

Quality Risk Management and Compliance

  • Facilitated qualification of high-risk and critical vendors and completed end-to-end GMP/supply chain risk assessment.

  • Raised and managed change control records to support full go-live, and advised on Part 11-aligned electronic signature requirements for dossier-bound documents.

  • Prepared and executed a simple validation protocol (OPQ) for the SharePoint QMS site, confirming functionality, access and controls without disrupting business-as-usual.

  • Established manual GxP registers alongside SharePoint metadata to preserve compliance while the platform's electronic systems mature.

The Outcome

  • A two-stage PQS Go-Live delivered on schedule — critical processes live ahead of initial Phase 1 and the full core QMS live ahead of the next trial stage.

  • A PQS SharePoint site with metadata-driven libraries and access controls, giving the client far more structure and searchability than a typical file-manager use of SharePoint, with procedural and access controls protecting critical GMP documents.

  • A bespoke digital signature and electronic master-forms process in SharePoint and Adobe, giving staff across multiple locations a fast, paperless way to complete and sign controlled forms.

  • A risk-based legacy migration that kept the new PQS free of low-value historical documents while preserving access to the client's R&D archive.

  • QSN retained for ongoing QA and compliance support beyond the project — with the client planning a future transition from SharePoint to a commercial eQMS as they scale into Phase 2 and Phase 3, a transition QSN looks forward to supporting.

Scaling from R&D into your first clinical trial?

Whether you're building a phase-appropriate PQS, setting up the architecture for a compliant document management system, or preparing for your clinical trial, QSN can help you get there — without over-building for where you are today.

Check out our relevant services - Clinical Trial Readiness and Sponsor Compliance or QMS.