Built by People Who Understand Regulated Industries.
Astakenis Consulting Pvt Ltd was founded to give life sciences companies a better alternative to complex quality management systems. Based in Bengaluru, our team brings direct experience working within pharmaceutical, biotech, and medical device quality operations, which shapes how we design and support OneQMS, our flagship cloud-based Quality Management Software.
We understand the pressure quality teams face to stay compliant while moving fast. That's why OneQMS is designed specifically for growing pharmaceutical, biotech, CRO, CDMO, and medical device organizations looking for an affordable, easy-to-implement, and scalable eQMS platform.
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Purpose-built for GMP, GxP, FDA 21 CFR Part 11 & EU Annex 11.
Cloud Native eQMS
Secure, scalable and accessible quality management platform.
Connected Quality
Quality processes connected across the entire lifecycle.
Easy Implementation
Quick deployment with configurable workflows and approvals.
Simplifying Quality Management for Regulated Industries
One connected platform that brings quality, compliance, documents, training, and operational excellence together.
Quality Management
Centralize quality activities and standardize workflows across regulated operations.
Document Management
Maintain version-controlled SOPs, policies, forms, specifications, and procedures.
Training Management
Automate training assignments, competency tracking, certifications, and reminders.
Connected Quality Processes
Link CAPAs, Deviations, Audits, Complaints, Incidents, OOS/OOT, and Change Controls.
Compliance Ready
Support regulatory compliance with electronic approvals, audit trails, and traceability.
Implementation & Support
Configure OneQMS around your existing quality processes with expert onboarding support.
Why Organizations Choose OneQMS
Purpose-Built for Life Sciences
Designed specifically for pharmaceutical, biotechnology, CRO, CDMO, and medical device organizations.
Connected eQMS Platform
Replace disconnected spreadsheets and manual quality processes with one integrated system.
Traceability Across the Quality Lifecycle
Maintain complete visibility between documents, audits, CAPAs, training, complaints, incidents, and quality events.
Simple to Implement. Easy to Use.
Configurable workflows help organizations adopt digital quality management faster.
Our Mission
To empower organizations worldwide with innovative quality management solutions, fostering continuous improvement and excellence in products, services, and processes.
Our Vision
To be the global leader in quality management systems, recognized for our unwavering commitment to driving efficiency, reliability, and customer satisfaction through cutting-edge technology and unparalleled expertise.