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.

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.

SimplerQMS ISO 13485:2016 Certification

regulatory compliance

We take full regulatory responsibility for your eQMS

We ensure compliance according to the requirements of the following standards, regulations, and guidelines.

FDA 21 CFR Part 820

FDA 21 CFR Part 820 Compliant

SimplerQMS is compliant with the FDA 21 CFR Part 820, a set of regulations that outlines Current Good Manufacturing Practice (CGMP) regulations. A requirement that all medical device manufacturers must follow concerning their quality system.

FDA 21 CFR Part 11 Compliant

FDA 21 CFR Part 11 Compliant

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.

GxP Compliant

GxP Compliant

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 Compliant

GAMP 5 Compliant

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.

EU GMP Annex 11 Compliant

EudraLex Annex 11 Compliant

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.

EU MDR and IVDR Compliant

EU MDR & IVDR Compliant

SimplerQMS is compliant 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).

pre-validated software

Avoid time-consuming validation

Computer System Validation is a requirement for life science companies that store and management quality records digitally. SimplerQMS provides a Pre-validated eQMS solution, which complies with the requirements of the GxP Guidelines, FDA 21 CFR Part 11 and ISO13485:2016. This means that your organization does not have to spend any time or money on system validation processes. Furthermore, we ensure continuous re-validation of the software and provide extensive validation evidence for use during audits and inspections.

Pre-Validated System
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.

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