Case Study: Helix Biotech achieves a rapid, paperless GMP eQMS and faster close-outs with Qualio

Why a biotech start-up's president sees his company 'flying' with Qualio

Helix Biotech, a Tennessee-based biotech founded in May 2022 that develops lipid nanoparticles, liposomes and manufacturing tools, needed a robust, GMP‑compliant quality system from day one. Founder Graham Taylor—who had endured a paper-based QMS that consumed a full FTE and slowed work—chose Qualio’s eQMS (using Documents, Training and Events plus Qualio+ guidance) to avoid manual paperwork and meet FDA/ICH requirements.

Qualio was implemented in October 2022 with industry-ready templates and Qualio+ support, enabling a rapid, fully paperless GMP foundation: about 90% of company activity now lives in Qualio, one FTE of quality admin was mitigated, quality event close‑outs are 3 days faster, 95% of scheduled training is completed on time with an average 2‑day completion, and Helix can present a digital quality program to win customers. Qualio’s ease of use and speed delivered a lean, scalable QMS that lets Helix focus on growth instead of admin.

Helix Biotech

Graham Taylor

President