Compliance Shouldn't Require an Army of People and a Mountain of Paper.
Audits shouldn't be a fire drill. Staying compliant with FDA, ISO, AS9100, and GxP should be a byproduct of how you work — not a separate effort on top of it.
Where Compliance Breaks Down
Manual records create audit risk
Paper-based records get lost, misfiled, or completed after the fact. When an auditor asks for evidence, the scramble begins.
Keeping SOPs current is exhausting
Engineering changes happen. Updating, approving, printing, and distributing revised SOPs to the floor is a full-time job — and operators still work from old versions.
Traceability gaps appear at the worst time
A customer complaint, a recall, or a regulatory inspection reveals that the traceability data you thought you had isn't complete enough to satisfy the question.
How Next Plus Makes Compliance Built-In
Compliance isn't a checkbox — it's a consequence of digital, enforced, and traceable operations.
Automatic Audit Trails
Every action, change, approval, and signature is timestamped and stored automatically. Nothing to remember, nothing to reconstruct.
e-Signatures
FDA 21 CFR Part 11, EU Annex 11, and GxP-compliant electronic signatures — with full authentication and audit logging at every sign-off point.
Controlled Document Management
Version-controlled work instructions with approval workflows. The moment a change is approved, operators on the floor see the updated version — instantly.
Built-In Standards
FDA 21 CFR Part 11, GxP, ISO 9001, AS9100, SOC 2 Type II, and ISO 27001 — supported out of the box, not bolted on.
Data Integrity by Design
ALCOA+ principles enforced at the system level. Data is attributable, legible, contemporaneous, original, and accurate — by default.
Audit-Ready at All Times
All records are searchable, filterable, and exportable in seconds. An audit is a query, not a crisis.
Ready to Make Compliance Effortless?
See how Next Plus turns compliance into a byproduct of how you work, not extra work on top of it.
צרו קשר
מלאו את הפרטים שלכם ונחזור אליכם בהקדם.