Qualio
41 Case Studies
A Qualio Case Study
Vector BioMed, a Maryland-based manufacturer of lentiviral vectors for gene therapies, needed to replace its paper-based quality system with a fully digitized, cGMP‑compliant eQMS while embedding ALCOA++ data integrity — all on a tight three-month timeline. After evaluating options, the company selected Qualio (including Qualio+) for an easy-to-use platform with rapid validation and industry-specific content.
Qualio delivered a Category 4 eQMS with pre-built biotech templates, hands-on migration support and in-depth validation documentation, enabling a right‑first‑time, paperless rollout in three months. The implementation centralized documents, training, supplier management, CAPAs and deviations; produced 400 live documents, onboarded 30 suppliers, achieved >95% on-time training, and enabled Vector BioMed to begin GMP production in November 2023 — outcomes the team attributes to Qualio’s support and validation approach.
Bennett Klusas
Quality Assurance Specialist