Adept Life Science Solutions combines purpose-built AI products with hands-on GxP consulting to help pharmaceutical, biotech and medical device companies protect data integrity, prove competency and keep validated systems in a validated state.
Built around 21 CFR Part 11 · EU GMP Annex 11 · GAMP 5 · ALCOA+
Aligned with
21 CFR Part 11EU GMP Annex 11GAMP 5ALCOA+HIPAASOC 2Each product addresses a gap that regulators keep finding — and that spreadsheets and periodic reviews can't close.
Watches your GxP systems around the clock, captures tamper-proof evidence and uses AI to connect data-integrity signals across systems — so you find issues in minutes, not at the next inspection.
Manages GxP training and competency end to end — from SOP to assessment to e-signature — and produces the audit trail and certified records inspectors ask for.
Continuously checks your AWS resources against versioned, approved GxP baselines, detects configuration drift the moment it happens and generates audit-ready evidence on demand.
Regulated work needs more than clever models. These principles shape every product we ship.
Our AI detects, drafts and prioritises. Qualified people review, decide and e-sign every regulated decision.
Data IntegrityIQ and Driftly deploy inside your own cloud account. Your data stays within your boundary.
We observe validated systems without writing back to them. Your source systems stay the system of record.
Every product produces inspection-ready, tamper-evident records — not just dashboards.
Technology alone doesn't pass an inspection. Our consultants have spent decades inside FDA- and HIPAA-regulated organisations, and we work alongside your team to design, validate and run compliant processes.
Book a consultationRisk-based validation for LIMS, ELN, CDS, MES and eQMS, aligned with GAMP 5 and FDA's Computer Software Assurance approach.
ALCOA+ gap assessments, audit-trail review programmes and remediation plans ahead of an inspection.
Practical controls for using AI in regulated work: intended use, risk assessment, human oversight and validation evidence.
GxP-ready AWS architecture, identity and access management, HIPAA and SOC 2 alignment.
Configuration, workflow design and validation support for laboratory informatics platforms.
Mock inspections, evidence packages and storyboards so your team can answer quickly and confidently.
Adept Life Science Solutions LLC is a consulting and solution development company that uses AI to help regulated life sciences companies maintain compliance with FDA GxP regulations.
We started Adept LSS because we kept seeing the same pattern across pharmaceutical, biotech and medical device organisations: capable teams buried in manual evidence gathering, periodic reviews that found problems too late, and generic tools that didn't speak the language of quality. We believed AI could change that — but only if it was designed from the ground up for the realities of validation, data integrity and inspection.
Today we combine three focused products with practical consulting. Our mission is simple: make continuous, provable compliance achievable for companies of every size, so their people can spend more time on science and patients and less time assembling binders.
Choose a solution, then pick a time that suits you. Every demo is a live, 30-minute session with a GxP practitioner — not a sales script.
Sampling audit trails once a quarter was a reasonable compromise when systems were few. In a connected GxP landscape, the risk lives between systems — and between reviews.
Read articleA signed read-and-understood form proves someone opened a document. It does not prove they can follow it. Here is how to close the gap between training records and real competency.
Read articleCloud teams treat drift as a security issue. In a GxP environment, an undocumented change to a validated system is a compliance event — and it needs to be treated like one.
Read articleTell us about your systems, an upcoming inspection or a challenge you are working through. We reply within one business day.