Certification & Regulatory Compliance
To display our commitment to regulatory compliance, SimplerQMS has always focused on maintaining certifications in the following regulatory guidelines and Life Science industry standards.
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regulatory compliance
We Take Full Regulatory Responsibility for Your eQMS
We support compliance according to the requirements of the following standards, regulations, and guidelines.
ISO 9001 Compliance
SimplerQMS supports compliance with ISO 9001, an internationally recognized standard that sets forth the criteria for a Quality Management System (QMS). The standard is utilized to showcase the organization’s capability to consistently deliver products and services that meet customer expectations and comply with relevant requirements.
ISO 13485 Compliance
SimplerQMS assists organizations in achieving compliance with ISO 13485. The ISO 13485 is an international regulatory standard that specifies the requirements for Quality Management Systems (QMS) in the medical device industry.
FDA 21 CFR Part 820 Compliance
SimplerQMS helps ensure compliance with FDA 21 CFR Part 820, a set of regulations that outline Current Good Manufacturing Practice (CGMP) regulations. Requirements that medical device manufacturers must follow concerning their Quality Management System (QMS).
FDA 21 CFR Part 11 Compliance
SimplerQMS supports the administration of electronic records and signatures in compliance with FDA 21 CFR Part 11. This involves maintenance of the detailed audit trail of actions performed on the documents, secure monitoring of individual actions, and certification of electronic signatures. We also ensure that your eQMS fulfills the validation requirement of FDA 21 CFR Part 11.
EudraLex Annex 11 Compliance
SimplerQMS is compliant with EudraLex Annex 11. A checklist that enables the European regulatory agencies to establish the requirements for computerized systems that relate to pharmaceutical products and medical devices. Including the criteria under which electronic records and electronic signatures are managed.
GxP Compliance
SimplerQMS helps you ensure that all your GxP documentation is up-to-date and that change control is managed efficiently. Demonstrate traceability using our audit trail functionality and let us take care of the GxP Computer System Validation requirements. We also help you proactively monitor for deviations, non-conformances, and market feedback – which are linked to CAPAs. Automating these activities will help your organization demonstrate GxP compliance.
GAMP 5 Compliance
SimplerQMS follows the guidelines of GAMP 5, which is a Risk-Based Approach to Compliant GxP Computerized Systems. The framework helps with computerized system validation where a system is assessed and assigned to a predetermined category based on its intended use efficiently and effectively.
ICH Q10 Compliance
SimplerQMS is designed to support organizations in achieving compliance with the ICH Q10 guideline. ICH Q10 provides guidance on pharmaceutical quality systems and describes a comprehensive model for an effective Quality Management System (QMS) in the pharmaceutical industry.
EU MDR & IVDR Compliance
SimplerQMS helps ensure compliance with EU MDR 2017/745 and EU IVDR 2017/746. Our post-market tools are integrated with modules like Supplier Management and Product Management, which helps you fulfill the requirements of EU MDR and EU IVDR. We also allow for PDF output for submissions according to the latest published guidelines for Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (AIMDD/MDD/IVDD).
certification
ISO 13485:2016 Certified
SimplerQMS has since 2018 been certified according to ISO 13485:2016 by Bureau Veritas.
This is the gold standard in the medical device industry, which guarantees a high quality of our products and services. An important part of the SimplerQMS Solution is that it is Pre-validated to fulfill the Computer System Validation requirement of ISO 13485:2016.
This means that your organization does not have to spend any time or money on system validation processes.
Download our ISO 13485:2016 Certificate here.
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fully validated software
Avoid Time-Consuming Validation
Computer System Validation is a requirement for Life Science companies that store and manage quality records digitally.
SimplerQMS is fully validated according to ISPE GAMP5 and is re-validated upon the creation of a new version or upon applying standard updates.
Have peace of mind with a system that complies with requirements regarding validation of systems used for QMS such as 21 CFR Part 11, and 820, EU GMP Annex 11, and ISO 13485:2016.
This means that your organization does not have to spend time or money on system validation processes. We ensure continuous software re-validation and provide extensive evidence for audits and inspections.
What kind of validation documentation and evidence do you provide?
- Validation Procedure
- Validation Plan
- Validation Report
- IQ, OQ and PQ Documentation
partner certifications
Store Your Documentation in Secure Cloud Servers
Our technology and hosting platform are based on M-Files and Microsoft Azure, which are certified according to the following standards.
ISO 27001:2013
A framework for managing IT security that provides the approach for organizations to identify which potential incidents could happen, after which define the procedures on how to change employee behavior to prevent such incidents from happening.
ISO 27018:2014
A security standard that helps cloud service providers to process personally identifiable information (PII) assessing risk and applying control measures to protecting PII in public clouds.
ISO 9001:2015
ISO 9001 is an international standard that defines the requirements for quality management systems (QMS). The organizations following the standard showcase the ability to consistently produce products and services that meet their customer and regulatory requirements.
See SimplerQMS in Action
To see SimplerQMS in action and learn how you can make the most of it, request a personalized demo presentation.
