Your Standards Are High. Ours Are Too. That’s Zen.
From rigorous security standards and independent certifications to GxP validation support, ZenQMS is built to protect your data, support your regulatory obligations, and give you confidence in the systems behind your operations.
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Your trust is our responsibility.
Validation without the extra hurdles.
Support isn't an upgrade.
Compliance, independently verified.
The documentation to back it up.
Compliance without compromise.
Protecting your data and supporting your regulatory obligations takes more than good intentions. Here's how we put our security, quality, and compliance to the test.
ISO 9001:2015 | Quality Management
ZenQMS maintains ISO 9001:2015 certification, demonstrating our commitment to consistent quality management practices, continual improvement, and customer satisfaction.
ISO 27001:2022 | Information Security
Our ISO 27001:2022 certification demonstrates an independently assessed approach to information security management, risk assessment, and protecting customer data.
SOC 2 Type II | Security Assurance
Independent SOC 2 Type II examinations assess the effectiveness of relevant security controls over time, providing additional assurance for vendor qualification and security reviews.
USDM Cloud Assurance | Life Sciences Qualification
Independent assessment and documentation designed to support risk-based cloud vendor qualification in regulated life sciences environments, helping customers streamline supplier assessments.
21 CFR Part 11 & EU Annex 11 | Compliant Electronic Signatures
All internal and external electronic signatures in ZenQMS are compliant with FDA 21 CFR Part 11 and EU Annex 11 requirements. ZenQMS enables secure, traceable electronic sign-offs across your regulated operations.
GAMP 5 & Computer System Validation | Validation Support
ZenQMS provides comprehensive validation documentation, qualification resources, and UAT templates to support risk-based computer system validation (CSV), following an approach informed by GAMP 5 principles.
HIPAA | Protected Health Information
ZenQMS implements administrative, physical, and technical safeguards designed to protect protected health information (PHI) in regulated healthcare environments. Business Associate Agreements (BAAs) are available for clients who require them.
GDPR | Data Privacy & Protection
ZenQMS maintains data protection practices aligned with the General Data Protection Regulation (GDPR), including safeguards for personal data privacy, security, and individual rights. Data Processing Agreements (DPAs) are available for clients who require them.
AWS Cloud Infrastructure | Security & Reliability
Hosted on Amazon Web Services (AWS), ZenQMS leverages secure cloud infrastructure, data protection measures, backups, and disaster recovery capabilities to support the security, availability, and continuity of critical quality operations.
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