Unify ERP and GMP operations into
one AI Platform

Cut batch release times by 30%, enable 5x faster documentation cycle times, and eliminate manual errors with our AI-powered GMP platform, built by founders who have walked your factory floors and faced your auditors.

One AI platform for global compliance
Zenopsys FDA complianceZenopsys GMP complianceZenopsys CGMP complianceZenopsys ICH complianceZenopsys FDA complianceZenopsys GMP complianceZenopsys CGMP complianceZenopsys ICH compliance
Testimonials

What Industry Leaders are Saying

user logo

When reviewing the platform, it's clear it was engineered with growth in mind. The unified solution is inherently more scalable than trying to bolt on different systems during a high-growth phase.

Jayanth Sridhar avatar
Jayanth Sridhar
CEO
user logo

They've clearly spent time thinking about the end-user on the production floor. The interface is intuitive, providing clear instructions and context at each step of batch execution.

Muralidhar
COO
user logo

The most compelling argument for Zenopsys from an IT standpoint is its unified platform approach. They’ve built a single, coherent GxP operating system rather than an assembly of acquired parts.

Radhakrishnan
VP IT
CMO, California

With simplified processes, instant, audit-ready records and transparent reporting, a CMO using Zenopsys can use their state of compliance as a proactive sales tool.

VP of Operations
user logo

For brands that outsource manufacturing, this ability to extend GxP control and maintain a single source of truth with their CMOs is a significant leap forward in mitigating risk.

Varun Chandra avatar
Varun Chandra
Vice President of R&D, Quality, and Regulatory

Unify ERP, quality and compliance into one AI platform

Purpose built for Life sciences

Why teams switch from spreadsheets and legacy software to Zenopsys

Legacy / Paper icon

Legacy / Paper

Outdated methods

  • Doesn't scale
  • High cost for customisations
  • Zero visibility
  • Lack of Integrations
  • High cost of operations
  • lengthy manual processes
  • AI cannot be implemented
Enterprise Software icon

Enterprise Software

Overcomplicated

  • Heavy customisation required
  • Long Implementation timeline
  • Siloed Systems
  • Expensive Integrations
  • High cost per Seat
  • Rigid processes
  • Data isn't AI-ready
Zenopsys icon

Zenopsys

Optimized solution

  • bullet iconReady-to-use, user-friendly modules
  • bullet iconGo live in 15 days
  • bullet iconUnified Platform
  • bullet iconIn built Integrations
  • bullet iconFlat pricing
  • bullet iconFlexible processes with AI automation
  • bullet iconAI native platform
Draft Compliant GxP Documents in Minutes, Not Weeks

Draft Compliant GxP Documents in Minutes, Not Weeks

Our DMS, featuring an industry-first AI document editor, significantly reduces administrative burden. Generate compliant first drafts of SOPs, Batch Records, or validation protocols with simple prompts, drastically cutting drafting time and ensuring regulatory alignment.
Accelerate Batch Release from Weeks to Days

Accelerate Batch Release from Weeks to Days

Our MES replaces paper batch records with electronic batch records (eBRs), enabling "review by exception." This allows your Quality team to focus only on deviations, leading to faster compliant batch releases and improved production cycle times.
Prevent Deviations Before They Happen

Prevent Deviations Before They Happen

Stop relying on manual checks and double-signing. Our MES and Asset Management modules create intelligent process interlocks. This system automatically verifies that operators are following the correct SOP steps, that the right materials are being used, and that only calibrated, validated, and clean equipment can be selected for a batch.
Automatically Close Training Gaps

Automatically Close Training Gaps

Our platform links your DMS and LMS. When a new SOP is approved in the DMS, the LMS automatically assigns training to affected roles. This ensures operators are always trained on the latest SOP, guaranteeing continuous compliance.
Streamline Your Entire Quality & CAPA Lifecycle

Streamline Your Entire Quality & CAPA Lifecycle

Our AI-native QMS provides a single, unified hub to manage all quality events—from deviations and non-conformances to investigations, change controls, and CAPAs. Flexible workflows adapt to your process, and AI assistance helps close out investigations and perform impact analysis for change management faster.
Guarantee 21 CFR Part 11 Compliance & Data Integrity

Guarantee 21 CFR Part 11 Compliance & Data Integrity

Our GxP-compliant platform offers immutable audit trails, secure e-signatures, and fine-grained access controls. This ensures tamper-proof records and full compliance with 21 CFR Part 11 and ALCOA+ data integrity, making you "always audit-ready."

Unify ERP, quality and compliance into one AI platform

Frequently Asked Questions

What is a pharmaceutical quality management system?Expand

How does CAPA automation enhance investigation efficiency and reduce repeat quality issues?Expand

Why is GMP compliance in the pharmaceutical industry critical?Expand

What features should I look for in QMS software for the pharmaceutical industry?Expand

What ROI can I expect from implementing a pharmaceutical QMS?Expand