Nonconformance Management for Life Science Companies
Nonconformance Management in SimplerQMS helps life science companies capture, investigate, and resolve nonconformances through connected quality workflows, improving traceability and process efficiency while supporting alignment with relevant quality requirements and standards.
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Explore Nonconformance Management in SimplerQMS
Managing nonconformances in regulated life science environments requires clear workflows, connected records, and traceability.
Explore how Nonconformance Management is supported in SimplerQMS through a guided product tour.
What You Can Achieve with SimplerQMS
Built by life science experts to strengthen traceability, improve efficiency, and support compliant Nonconformance Management in one integrated eQMS.
“SimplerQMS makes things flow easier.”
End-to-End Traceability
Connect nonconformances with investigations, evidence, CAPAs, and related quality records so teams can follow decisions and actions from identification through resolution.
Efficient Follow-Up
Manage nonconformances through structured workflows with clear ownership, risk-based categories, and connected quality records in one eQMS, reducing reliance on disconnected systems.
Regulatory Assessment Support
Document nonconformance assessments and vigilance reporting decisions where applicable, while keeping supporting evidence and follow-up actions connected within the quality process.
Continuous Improvement
Monitor follow-up activities and recurring trends using connected quality information to support data-informed process improvement.
How Different Roles Benefit from Nonconformance Management in SimplerQMS
Life science teams use Nonconformance Management in SimplerQMS to support their responsibilities across quality, regulatory, development, and operations.
Quality Assurance (QA)
Regulatory Affairs (RA)
Research and Development (R&D)
Manufacturing and Operations
Management and Executives
How Life Science Teams Use Nonconformance Management in Practice
Explore how life science teams use Nonconformance Management in SimplerQMS to handle different quality events with greater structure, traceability, and control.
Manage Manufacturing Material or Batch Nonconformances
With SimplerQMS:
Manage manufacturing-related quality events in a controlled workflow while maintaining traceability across investigations, evidence, and corrective actions.
Manage Product or Design-Related Nonconformances
With SimplerQMS:
Maintain visibility into product-related events and ensure quality decisions are documented throughout the product lifecycle.
Manage Testing Deviations and Quality Issues
With SimplerQMS:
Handle testing-related nonconformances consistently while keeping investigation evidence and follow-up activities connected.
Manage Client and Operational Quality Events
With SimplerQMS:
Maintain clear oversight of nonconformances arising from client activities, laboratory services, manufacturing, materials, or project execution.
How SimplerQMS Supports These Use Cases
Explore the core capabilities in SimplerQMS that support Nonconformance Management and help life science teams manage quality events in a structured and controlled way.
Structured Workflows
Guide nonconformances through assessment, review, approval, and closure with defined workflow steps and notifications.
Connected Quality Records
Keep observations, nonconformances, CAPAs, and related quality records connected throughout the process, supporting clearer traceability without recreating information across disconnected systems.
Supporting Documentation
Attach supporting evidence and documentation directly to the nonconformance record, supporting relevant context available for investigation, review, and decision-making.
Role-Based Access Control
Assign responsibilities and control who can view, edit, review, or approve nonconformance records based on their role.
Vigilance Reporting
Identify and assess nonconformances that may have implications for released product quality or patient safety. This supports Regulatory Affairs and Post-Market Surveillance teams when evaluating reporting requirements.
Electronic Signatures
Capture approvals with traceable electronic signatures designed to align with FDA 21 CFR Part 11 requirements.
Microsoft Office Integration
Draft and edit supporting documents in Microsoft Word while keeping them connected to the relevant quality records in SimplerQMS.
Search, Filtering, and Status Views
Locate nonconformance records using search, filters, and status-based views such as Active or Archived.
Nonconformance Management is Built into an Integrated eQMS
Nonconformance Management is supported within SimplerQMS’s integrated eQMS for life science companies rather than as an isolated quality process. It connects with related processes such as investigations, CAPA, and Change Control to keep follow-up activities linked. For example, a nonconformance can be connected to a related CAPA or change, supporting continuity and traceability across the quality system. This gives teams clearer visibility across connected quality activities within one controlled system.
Explore our QMS Software
More Than Just Nonconformance Management
Beyond Nonconformance Management SimplerQMS supports a wide range of interconnected quality processes within a fully integrated eQMS.
Supporting Compliance with Life Science Requirements
SimplerQMS enables organizations to implement Nonconformance Management aligned with key life science requirements by helping organizations maintain traceability, streamlined resolution, and consistent processes.
SimplerQMS A/S is certified to ISO 13485:2016, and the SimplerQMS software is designed to support and align with the requirements of the ISO 13485 quality management system.
SimplerQMS A/S maintains information security controls aligned with ISO/IEC 27001:2022 across its organization and QMS software platform.
SimplerQMS complies with FDA 21 CFR Part 11.
SimplerQMS supports compliance with FDA 21 CFR Part 820.
SimplerQMS supports GMP requirements under FDA 21 CFR Part 211.
SimplerQMS supports compliance with FDA 21 CFR Part 212.
SimplerQMS support compliance with FDA 21 CFR Part 4.
SimplerQMS supports FDA Data Integrity Guidance (FDA-2018-D-3984) principles.
SimplerQMS supports adherence to CLIA.
SimplerQMS supports compliance with EudraLex Volume 4 GMP (Part 1 – Medicinal Products).
SimplerQMS supports compliance with EudraLex GMP Annex 11: Computerized Systems, Annex 16 QP certification for batch release, and Annex 19 reference/retention samples.
SimplerQMS supports compliance with EU MDR.
SimplerQMS supports compliance with EU IVDR.
SimplerQMS empowers life science organizations to meet UK MDR requirements.
SimplerQMS facilitates adherence to ISO 14971:2019.
SimplerQMS supports compliance with IEC 60601.
SimplerQMS supports alignment with IEC 62304.
SimplerQMS provides functionality aligned with ISO 1518:2022.
SimplerQMS supports compliance with ISO 16085:2021.
SimplerQMS aligns with pharmaceutical quality systems requirements per ICH Q10.
SimplerQMS supports risk management per ICH Q9.
SimplerQMS supports compliance per ICH Q8.
SimplerQMS supports compliance with PIC/S GMP (Part 1 – Medicinal Products).
SimplerQMS meets ISPE GAMP 5 guidelines, including Annex D1, Section 3 and Annex M3.
SimplerQMS supports compliance with ISO 9001:2015.
SimplerQMS applies ISO 90003:2018 best practices.
SimplerQMS follows ISO/IEC 27002:2022 guidance.
SimplerQMS supports alignment with GDPR (EU).
HIPAA
SimplerQMS supports alignment with HIPAA (US).
Hear From Our Happy Customers
Explore real-world case studies and customer reviews that show how life science teams use SimplerQMS.
‘’SimplerQMS has been an excellent solution for our team. The platform is intuitive and user-friendly, and the implementation process was incredibly smooth. We were able to go live in just 6 weeks…’’
“The ease of use, customizability, and the support given by the technical support team…Very fast in their response.”
‘’SimplerQMS is much better than our previous paper-based QMS system…SimplerQMS gave us excellent pricing, customer support for understanding how to use their system and set up our QMS and is easy to use.’’
“…I have consistently been impressed with its flexibility and range of features. These features have met all my needs in every aspect. The excellent support team further enhances the overall experience.”
“Amazing customer support and help. The system is clearly structured. After the introduction, it is easy to use.”
‘’User-friendly and simple to use. Easy to customize to fit your individual needs.’’
‘’Exceptional customer support! Compliant to 21 CFR Part 11 and ISO 13485:2015.’’
‘’…SimplerQMS offers the bare necessities and is perfect for our needs.’’
Explore Nonconformance Management Resources
Explore practical insights and guidance on Nonconformance Management in regulated life science environments.
Frequently Asked Questions (FAQ) about Nonconformance Management
Find answers to common questions about Nonconformance Management and its role in life science quality management.
What is Nonconformance Management in SimplerQMS?
Nonconformance Management in SimplerQMS helps life science companies capture, investigate, and resolve instances where a product, process, material, or requirement does not meet defined specifications or quality standards. Teams can assign ownership, classify nonconformances, maintain supporting evidence, and manage follow-up activities within one controlled eQMS. This supports consistent workflows, traceability, and audit trails across the nonconformance lifecycle.
How Does Nonconformance Management Connect to Quality Events?
Nonconformance is one type of Quality Event managed in SimplerQMS. It can be identified directly or created from an observation when further investigation or follow-up is required. Teams can then manage assessment, investigation, resolution, and related actions while keeping connected records traceable within the integrated eQMS.
Can a Nonconformance be Created from an Observation?
Yes. Employees can report a potential quality issue as an observation without first deciding how it should be classified. The observation can then be reviewed and, when appropriate, escalated to a nonconformance while maintaining the connection between the records. This supports broader employee participation in quality reporting while keeping classification and follow-up controlled.
Can I Link a Nonconformance to a CAPA?
Yes. When an investigation identifies the need for corrective or preventive action, a related CAPA can be connected to the nonconformance. This keeps the original event, investigation findings, actions, and CAPA history linked for end-to-end traceability.
How Does Nonconformance Management Support Post-Market Surveillance?
Nonconformance Management can support Post-Market Surveillance by helping teams document, investigate, and track product-related quality events identified after release. Teams can maintain supporting evidence, assess product impact, and connect related actions such as CAPA when required. Traceable records of investigations, decisions, and follow-up activities can also support regulatory assessment and reporting decisions.
How Does Nonconformance Management Support Traceability?
SimplerQMS keeps nonconformance details, investigation records, supporting evidence, decisions, approvals, actions, and related CAPAs connected. Teams can follow what happened, how the event was assessed, what actions were taken, and how follow-up was completed. This reduces the need to reconstruct information across disconnected systems.
See SimplerQMS in Action
See how SimplerQMS supports Nonconformance Management and other interconnected quality processes in a single, integrated eQMS.
