AI-Powered Quality Management Platform

OneQMS

One Integrated Platform for Quality, Documents and Training Excellence.

AI that turns quality data into smarter decisions, faster workflows, and proactive compliance.

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About Astakenis

Welcome to Astakenis, a pioneering provider of Astakenis OneQMS, a cutting-edge, cloud-based Quality Management System (QMS) platform designed to meet the demanding requirements of Pharmaceutical Manufacturing, Biotechnology, Medical Devices, Clinical Research Organizations (CROs), and Contract Development & Manufacturing Organizations (CDMOs). OneQMS brings together Quality Management, Document Management, and Training Management in a single, connected platform, helping organizations streamline quality operations, strengthen compliance, and improve efficiency.

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Purpose-Built for Regulated Industries.

OneQMS helps pharmaceutical, biotechnology, CROs, CDMOs, medical devices, and other regulated organizations simplify quality management, strengthen compliance, and maintain inspection readiness through one connected cloud-based eQMS platform.

Connected Quality Management

Manage CAPAs, Deviations, Change Controls, Audits, Complaints, Incidents, OOS/OOT, Documents, and Training from one connected platform.

GMP and GxP Compliance

Support GMP, GxP, FDA 21 CFR Part 11, and EU Annex 11 requirements with secure electronic records and audit trails.

Inspection Readiness

Maintain complete traceability across quality events, approvals, documents, investigations, and historical records.

Workflow Automation

Automate assignments, notifications, escalations, approvals, due dates, and quality workflows across departments.

Cloud-Based eQMS Platform

Provide secure access, configurable workflows, role-based permissions, and centralized quality management across multiple sites.

Medical Devices Quality Management

Manage quality processes throughout the medical device lifecycle with connected quality records and investigations.

Complaint Handling and CAPA

Capture customer complaints, investigate issues, identify root causes, and manage corrective and preventive actions.

Change Control Management

Evaluate design, manufacturing, supplier, and process changes with structured approval workflows.

Document and Training Control

Maintain controlled SOPs, work instructions, revision history, employee training, and competency records.

Regulatory Compliance

Support FDA 21 CFR Part 820, FDA 21 CFR Part 11, GMP, GxP, and EU Annex 11 compliance requirements.

Project and Quality Oversight

Standardize quality management across customer projects, laboratories, manufacturing sites, and supplier activities.

Audit and Supplier Management

Manage internal audits, supplier audits, audit findings, corrective actions, and compliance activities.

Customer Complaint Management

Capture, classify, investigate, respond to, and close customer complaints through controlled workflows.

Quality Issues and Incidents

Identify, assess, investigate, assign actions, and resolve quality issues and operational incidents.

Connected Quality Records

Maintain traceability between CAPAs, Deviations, Change Controls, Complaints, Audits, OOS/OOT, Documents, and Training.

Quality Event Management

Capture, investigate, and manage quality events through configurable workflows and controlled approvals.

Document Control

Manage controlled documents, version history, approvals, periodic reviews, archival, and retirement.

Training Management

Assign role-based training, maintain competency records, manage certifications, and track training completion.

Risk-Based Workflows

Configure workflows, approvals, notifications, escalations, and responsibilities based on organizational quality procedures.

Compliance and Inspection Readiness

Maintain electronic signatures, audit trails, role-based access, complete traceability, and centralized quality records for inspections.

Astakenis OneQMS: See It in Action

A glimpse into smarter quality process automation.

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“We needed a QMS that our team would actually use, not another complicated system to manage.” Before OneQMS, several of our quality activities involved emails, spreadsheets, and manual follow-ups. What stood out to us was how straightforward OneQMS was for our users while still giving the Quality team the controls we needed. The implementation was practical, and the team at Astakenis worked with us to configure the system around our processes rather than forcing us to change everything to fit the software.

Director, Quality Systems Pharmaceutical Company, USA

“The flexibility of OneQMS made a real difference for us.” Our quality processes were already established, so we were not looking for a system that would simply give us a standard workflow. We needed something that could accommodate the way our teams actually work. With OneQMS, we were able to configure workflows, responsibilities, reviews, and approvals around our requirements. It has given us a much clearer way to manage quality activities without making the process unnecessarily complicated.

Quality Assurance Manager Pharmaceutical Manufacturing Company, Europe

“OneQMS has made it much easier for us to keep track of what is happening across our quality processes.” As a growing CRO, we wanted to move away from managing quality activities across different files and email conversations. OneQMS gave us a single system for managing our quality records and following activities through to completion. The interface was easy for our teams to understand, which helped us get people using the system without making the transition more difficult than it needed to be.

Head of Quality CROs, India

We Deliver Real Results for Our Clients

50+

Customers

50+

Customers

Trusted by a growing base of enterprise customers worldwide.

50,000+

Users

50,000+

Users

Empowering active users across teams and quality operations.

1 Million+

Documents

1 Million+

Documents

Seamlessly maintain documents.

1 Million+

Quality Records

1 Million+

Quality Records

Maintaining structured, traceable quality records seamlessly.

1 Million+

Quality Events

1 Million+

Quality Events

Effortlessly logging and resolving critical quality events.

10 Million+

Training Records

10 Million+

Training Records

Tracking compliance and employee training completions at scale.

Trusted by Leading Life Sciences Organizations

Frequently Asked Questions.

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What is OneQMS?

OneQMS is a cloud-based Electronic Quality Management System (eQMS) designed for pharmaceutical, biotechnology, CROs, CDMOs, medical device, and other regulated organisations to manage quality processes through a connected digital platform.

OneQMS includes Document Management, Training Management, CAPA, Change Control, Deviations, Audit Management, Customer Complaints, Quality Issues, Incidents, OOS and OOT, and eLogs, providing a connected approach to quality management.

Yes. OneQMS is designed for organisations operating under GMP, GxP, FDA 21 CFR Part 11, and EU Annex 11 requirements, with features such as controlled workflows, electronic approvals, role-based access, and audit trails.

Yes. OneQMS provides configurable workflows, forms, roles, permissions, approvals, notifications, and other controls, allowing organisations to align the platform with their established quality procedures.

Yes. OneQMS provides audit trails and electronic signatures for applicable quality activities, supporting traceability and controlled electronic records in regulated environments.

Yes. OneQMS connects related quality records across modules, allowing information such as CAPAs, Deviations, Change Controls, Documents, Training, Audits, Complaints, OOS/OOT, Incidents, and Quality Issues to be associated where applicable. This helps maintain end-to-end traceability across the quality management system.