ComplyIQ Pro: Turn every SOP into a verified, audit-ready competency record.
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.
21 CFR 211.25 · ISO 13485 §6.2 / QMSR · 21 CFR Part 11 · EU Annex 11
Most training systems prove people completed training — not that they understood it.
- Trained is not competent. Read-and-understood sign-offs do not demonstrate that people can perform the procedure.
- A recurring finding. Inadequate training and personnel qualification are a frequent cause of FDA 483 observations and warning letters.
- Paper does not hold up. Spreadsheets and sign-off sheets are hard to defend and slow to retrieve during an inspection.
- Authoring takes time. Writing good assessments for every SOP revision ties up subject-matter experts.
What ComplyIQ Pro does
SOP upload or existing source
Upload SOPs directly or connect SharePoint, Veeva Vault, MasterControl or a webhook from the system you already use.
Real competency assessment
Multiple choice, fill-in-the-gap and true/false questions, with critical-question logic that a learner must get right to pass.
AI-assisted drafting, human-approved
Draft questions grounded in your SOP text. A reviewer must approve every assessment before it is assigned.
Part 11-style e-signatures
Typed name, live password re-entry and attestation on passing — linked to the exact SOP version.
Immutable audit trail
An append-only log of every action. Nothing can be edited or deleted.
Certified PDF dossiers
Per-person training records with a SHA-256 checksum, ready to hand to an inspector.
Four steps from signal to evidence
Connect
Upload your SOP or connect your document source.
Build
Write the assessment, or draft it with AI and have a reviewer approve it.
Assign
Learners complete training and e-sign on passing.
Prove
Pull the audit trail or a certified dossier for any person and SOP version in minutes.
Built for regulated teams
- Small and mid-size pharma, biotech and medical device companies
- CMOs, testing labs and clinical research organisations
- VP/Director of QA, Heads of GMP Training and L&D, Site Quality Managers
- Validation leads, Regulatory Affairs and IT Quality / Data Integrity teams
Deployment
Cloud-hosted with self-serve sign-up and strict tenant isolation — every organisation's data is completely private. A dedicated deployment inside your own AWS account is available when you require it. Priced per SOP document processed: no seat fees and no long-term contract.
Common questions
Does the AI write our training?
It drafts. Every question is grounded in your SOP text, and a human reviewer must approve the assessment before it can be assigned.
Can we keep using our document management system?
Yes. Connect SharePoint, Veeva Vault, MasterControl or any system that can send a webhook, or simply upload SOPs.
How is it priced?
Per SOP document processed. There are no per-seat fees and no long-term contract.
Is it validated?
ComplyIQ Pro supports 21 CFR Part 11 and EU Annex 11 principles. We provide validation support, and final compliance depends on your own validation and procedures.
See ComplyIQ Pro in a live 30-minute demo
Bring your questions — we'll show you how it works in a GxP environment like yours.
Also from Adept LSS: Data IntegrityIQ — gxp data integrity and Driftly — gxp cloud compliance.