Case Study

Phased Rollout, Customisation & Robust Training to Achieve ISO 9001 & 13485 Readiness

CASE STUDY
Phased Rollout, Customisation & Robust Training to Achieve ISO 9001 & 13485 Readiness

Challenge

Committed to advancing healthcare solutions while maintaining the highest standards of compliance, the company set a mandate to achieve ISO 9001 and ISO 13485 certifications, recognising the need for a structured, scalable eQMS to replace SharePoint and manual processes.

When a new Quality Assurance Manager with prior eQMS experience joined, the mission was clear: build an eQMS capable of staying audit-ready and securing ISO certifications.


  • Initial tools (SharePoint & manual forms) lacked audit trails, version control, and access management.

  • Acting as a "lead and only quality expert at the time", the QA Manager required a partner who could provide not just software, but ongoing support and reassurance.

  • Accreditation needs were heavy: document control, training, NCRs, CAPA, assets & equipment, with audits ,management reviews and supplier management to follow.

Kike Iwaye, Quality Assurance Manager, Virax Biolabs Group:

About

Virax Biolabs Group is a global pharmaceutical manufacturer developing immune profiling solutions and T-cell diagnostics for COVID-19 and other viral threats. The company is committed to advancing healthcare solutions while upholding the highest standards of compliance.

Employees:

~10-50


Industry:

Biotechnology / Pharmaceutical Manufacturing


Industry Affiliations and Standards:

ISO 9001:2015,
ISO 13485:2016


Location:

UK, Canada, Shanghai, Hong Kong


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Results at a Glance

Audit readiness
Remote audits completed successfully with full traceability and instant evidence access.
Compliance & certifications
Structured rollout supported ISO 9001 & ISO 13485 certification readiness.
Interconnected workflows
NCRs, CAPAs, and equipment records are fully linked - ensuring end-to-end traceability.
Support & customisation
Trackmedium delivered hands-on support and tailored customisation, unlike other vendors that required rigid processes or extra systems.

Solution

  1. Phased Rollout
    Virax adopted Trackmedium in staged phases:

    • Started with Document Control & Training

    • Expanded to NCRs & CAPA

    • Added Assets & Equipment (critical for regulated operations)

    • Planning to implement Audit Management,, Supplier Management & Management Reviews

Customisation
Out-of-the-box functionality was strong, but certain needs such as complex document control nomenclature required customisation. Trackmedium's team provided hands-on support, avoiding the need to rewrite SOPs.

Results

Training & Adoption

  • "Read & Understood" acknowledgments provide compliance-ready training records.
  • Monthly training reviews are supported with colour-coded training matrix printouts, enabling the QA Manager to present a clear visual picture of team status.
  • Staff received initial user training as well as train-the-trainer sessions, ensuring both broad adoption and in-house expertise to support colleagues.
  • Before: manual, paper-based files made audits stressful.
  • Now: training records, certificates, and logs are fully digital, accessible remotely, and easy to share with auditors.

NCR & CAPA Management

  • Customized phases work seamlessly.
  • NCRs and CAPAs integrate directly into procedures.
  • Equipment faults link to CAPA with one reference number tracked across the lifecycle.
  • Auditors noted the strength of the traceability.

Audit & Compliance

  • Full access control and audit trails ensure accountability. Granular access controls and full audit trails safeguard compliance - ensuring every user only sees what they're authorised to, and eliminating the risk of document misuse that is a risk with SharePoint.
  • SharePoint lacked signature trails - Trackmedium ensures every action is logged.
  • Audit modules can integrate into NCs and CAPA modules as positive feedback on simplicity and searchability.

Cultural Impact

  • Staff from academic backgrounds adapted quickly, supported by Trackmedium's intuitive design.
  • Mindset shifted from manual to digital, embedding compliance into daily work.
  • Independence increased - staff now operate with the right level of control based on their roles, aligned with regulations.

Future Plans

  • Explore additional modules already included in the package (e.g. HSE, Incident & Accident Management, Safety).
  • Ongoing validation rounds and refinements (e.g. wording in training acknowledgments).
  • Safety currently managed locally by R&D, but will be integrated into Trackmedium as the company grows.
09

"Trackmedium eQMS enabled Virax to complete its last audit fully remotely. Both Virax and the auditor were off-site - no one needed to even step into the lab. This flexibility reflects today's hybrid working reality and gave auditors instant access to the evidence they required."


- Kike Iwaye,
Quality Assurance Manager, Virax Biolabs Group.

Conclusion

  1. By replacing SharePoint with Trackmedium eQMS, Virax Biolabs achieved a faster, more reliable path toward ISO 9001 and 13485 certification. The phased approach, customisation support, and robust training delivered tangible results:

    • smoother audits, including fully remote inspections

    • traceability from training through to equipment CAPA

    • empowered staff and a stronger culture of quality

    Trackmedium continues to support Virax as it scales its QMS into safety and future compliance needs.

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