Enzyme ships its quality system validated out of the box, which shortens the qualification effort regulated buyers normally face. Its modules span the full device lifecycle from design control through postmarket complaints and CAPA.
The platform pairs software with in-house consulting that covers submissions, audits, and quality-system setup. That combination lets small teams buy one vendor for both the system and the expertise to run it.
In July 2025 Greenlight Guru announced that Enzyme would join its organization, pairing two quality management vendors for the life sciences market. The announcement framed the move as a way to serve regulated teams across a wider product range.
Enzyme customers were told to expect continuity, with the Enzyme site noting an ongoing transition for existing accounts. The combined group continues to support quality-system implementation for startup and enterprise teams.
Enzyme eQMS is a cloud-based quality management system aimed at medical device, digital health, and biopharma groups. It covers document control, change control, training, design control, risk management, suppliers, audits, complaints, nonconformance, and CAPA.
The system is built to be compliant with 21 CFR Part 11 and arrives validated out of the box for regulated use. It connects with common engineering tools and ships with a large library of audit-tested procedure templates.
