In our customers’ own words

“We were initially unsure how AI could meet strict regulatory demands, but Litewave delivered auditable insights in just days, without needing our own AI team or complex system changes. With the digital footprint created by Litewave, we are now always audit-ready and confident in every inspection. Litewave helped us modernize our compliance processes, while continuing to work with our paper-based records. We are now using it to drive both yield and quality, without the disruption or costs of a full eBPR migration.”

“The challenges Litewave is tackling around CDMO oversight, GMP compliance, and audit readiness are ones I've been dealing with every day for over a decade. Cell therapy manufacturing involves layers of contract partners, deviation reports, and audit-ready documentation that simply weren't built to scale. There's a real intersection between what Litewave is building and the real-world manufacturing workflows in cell and gene therapy. Tools that let practitioners spend less time chasing paperwork across partners and more time on the science are exactly what this industry has been waiting for.”

“Our product mix is constantly changing as new client contracts come in and others wind down, so we weren't sure any AI platform could really keep up with a CMO like ours. Litewave has. It enhances both compliance and productivity in ways our existing systems simply can't, and the depth of pharma-specific knowledge baked into the platform is rare. From day one, the options for review and tracking have significantly improved our workflow and efficiency.”

“What used to take our team weeks of manual review now happens in days, with full ALCOA+ alignment baked in. Our deviation closure cycle has shrunk dramatically, and we're catching trends in batch records that we used to only see in retrospective audits. For a sterile fill-finish operation where every minute of regulatory delay costs real money, the investigation timelines speak for themselves.”

“We oversee batch records and deviations across multiple CDMOs operating on different MES, LIMS, and document management platforms. Litewave gives us a single audit-grade view across all of them, without forcing every partner onto the same system or rebuilding our oversight stack. When the FDA asks us to produce a complete trace across our supply chain, we can. That alone has changed how we structure our CDMO contracts.”