The AI-powered QMS for operational excellence
Ensure manufacturing excellence, gain productivity, and improve employee safety on a single cloud platform, backed by a document AI you can trust.
Performance and productivity boost
fewer errors than manual, paper-based processes
minimum implementation time savings
first-time yield improvement
Based on AODocs QMS customers.
A full-feature QMS, adaptable to your processes
Every quality document, under control
Ensure consistency and traceability across your organization: managed lifecycles from draft to distribution and end of life, versioning, approvals, and permissions on work instructions, SOPs, and technical documentation.
CAPA, audits, and supplier management built in
Run corrective and preventive actions, audit preparation, and supplier documentation on the same platform as your documents. When auditors come, reports and evidence are a query away, not a scramble.
Manage change without disrupting operations
Roll out updated procedures, new equipment documentation, and revised standards through an integrated change control process: planned, approved, distributed, and traced from trigger to effective date.
Assemble documents from validated templates
Generate controlled documents from approved templates and live data, keeping formatting and mandatory clauses right by construction.
Deliver and solve faster with trusted AI
The right information, from the right document
AI assistants retrieve answers from your controlled documents, and only from them. Simplify access to manufacturing instructions, speed up employee training, and accelerate troubleshooting on the shop floor.
Classification and extraction, without the tedium
Generative AI classifies documents, extracts data, and populates metadata automatically, feeding your workflows, access permissions, and retention rules without manual re-entry.
Compliant from day one, collaborative by design
FDA and ISO ready, out of the box
Meet FDA 21 CFR Parts 11 and 820, ISO 13485, ISO 14971, and other industry standards from the start: AODocs comes as a qualified platform with a validated library.
Training and EHS procedures, tracked
Reduce accident risks by keeping every team member current on safety training and EHS procedures, with acknowledgment tracking and compliance dashboards.
Share the right version, inside and out
Retire the rogue copies in email threads: partners, customers, and suppliers work on the controlled version, inside your document processes, with the same security and traceability as internal teams.
AODocs was unique compared to other offerings we evaluated in that it's a platform versus a solution... we could configure it to meet our specific needs.
Hector Solano
Chief Operating Officer
Frequently asked questions
How do you fix a non-conformance?
Fix a non-conformance by addressing the detected issue, recording the agreed disposition and assigning responsibility for the work. Then assess whether corrective action is needed to address its cause and prevent recurrence. An NCR workflow should distinguish those decisions and their evidence; fixing the immediate defect does not establish that the cause has been addressed.
How does ISO 19650-1 relate to revision control practice?
ISO 19650-1:2018 outlines concepts and principles for managing information across the life cycle of a built asset, including exchanging, recording, versioning and organizing information. It does not define a universal revision-numbering scheme. ISO lists this edition as current but under revision; verify the edition named by the applicable contract.
What is an audit trail and why do regulators require one?
An audit trail is the chronological, tamper-evident record of everything that happens to a document: who created, modified, approved, or deleted it, and when. Regulators require one because a rule you cannot prove you followed is, for an auditor, a rule not followed. Frameworks such as FDA 21 CFR Part 11, ISO 9001, SOX, and the EU's GPSR all expect organizations to reconstruct events and demonstrate timely action. A complete trail turns an inspection from an investigation into a lookup.
What should a document control software pilot test?
Use representative documents, metadata, roles, and external participants. Test revision status, approval, transmittal, restricted access, reports, export, and handover evidence against agreed acceptance criteria.
Ready to get started?
See what AODocs can do for your company, let's connect.