Rephine’s expertise in QMS and digital transformation was critical to our success. The project not only improved our compliance posture but also made day-to-day work far more efficient.
Client Testimonial
About this Case Study
How Rephine supported a fast-growing biopharmaceutical CDMO in fully digitalizing its quality operations to drive compliance, efficiency, and scalability.
As manufacturing operations rapidly expanded, a Spanish-based biopharmaceutical CDMO faced increasing risks and inefficiencies caused by manual, paper-based quality systems. With limited visibility, fragmented records, and time-consuming workflows, the company needed a validated, digital Quality Management System (QMS) to keep pace with its growth and regulatory expectations.
Rephine delivered a two-phase transformation project that modernised the CDMO’s entire quality infrastructure. This included the implementation of a validated QMS, followed by deployment of integrated Document Management (DMS) and Training Management (TMS) modules — all aligned with GxP and Computer System Validation (CSV) best practices.
Download the full case study to discover how Rephine helped the client:
- Implement and validate a digital QMS within five months
- Fully digitalize document and training management processes
- Increase training compliance to over 95% within six months
- Reduce document approval and retrieval times by 30%
- Eliminate audit findings related to document and training records
Result: A scalable, audit-ready digital QMS framework enabling real-time visibility, operational efficiency, and sustained regulatory compliance.
Download the Case Study
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