Deviation Management for Life Science Companies
Deviation Management in SimplerQMS helps life science companies capture, investigate, and resolve deviations in one connected workflow, improving traceability and visibility while supporting alignment with relevant life science requirements and quality standards.
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Explore Deviation Management in SimplerQMS
Managing deviations in regulated life science organizations requires structured processes, clear documentation, and traceability.
Explore how Deviation Management is supported in SimplerQMS through a guided product tour.
What You Can Achieve with SimplerQMS
Built by life science experts to streamline deviation handling while keeping investigations, evidence, decisions, and follow-up controlled and traceable.
“SimplerQMS makes things flow easier.”
End-to-End Traceability
Connect deviations with investigations, evidence, CAPAs, and related quality records so teams can follow decisions and actions across the deviation lifecycle.
Efficient Deviation Handling
Manage planned and unplanned deviations through structured workflows with defined ownership, risk-based categories, reviews, approvals, and connected follow-up actions.
Regulatory Assessment Support
Document deviation assessments and vigilance reporting decisions where applicable, while keeping supporting evidence and follow-up actions connected within the quality process.
Continuous Improvement
Monitor deviation activity, identify recurring trends, and track follow-up actions to support data-informed quality improvements.
How Different Roles Benefit from Deviation Management in SimplerQMS
Life science teams use Deviation 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 Deviation Management in Practice
Explore how life science teams use Deviation Management in SimplerQMS to investigate issues, coordinate follow-up, and maintain traceability across related quality activities.
Assess and Resolve a Manufacturing Process Excursion
With SimplerQMS:
Maintain a complete and traceable record of the event, enabling QA teams to make documented product quality decisions.
Identify Recurring Deviations and Improve Processes
With SimplerQMS:
Gain better visibility into process weaknesses and move from reactive problem-solving toward continuous improvement.
Investigate a Supplier or Material-Related Deviation
With SimplerQMS:
Maintain supplier quality oversight with documented evidence of investigation and decision-making.
Investigate Documentation or Procedure Deviations
With SimplerQMS:
Ensure documentation errors are investigated, corrected, and prevented from recurring.
How SimplerQMS Supports These Use Cases
Explore the capabilities that help life science teams manage deviations with greater control, traceability, and efficiency.
Structured Workflows
Guide deviations through assessment, review, and approval with defined workflow steps and notifications.
Connected Quality Records
Keep observations, deviations, CAPAs, and related quality records linked within one eQMS, helping maintain traceability without recreating information across disconnected systems.
Supporting Documentation
Upload or drag and drop supporting documentation when creating a deviation, helping provide additional context for review and assessment.
Role-Based Access Control
Control who can view, edit, review, or approve deviation records based on assigned roles.
Vigilance Reporting
Identify and assess deviations that may require further regulatory evaluation. This helps Regulatory Affairs and Post-Market Surveillance teams review potential reporting requirements where applicable.
Electronic Signatures
Capture approvals using traceable electronic signatures designed to align with FDA 21 CFR Part 11 requirements.
Microsoft Office Integration
Draft and edit relevant documents in Microsoft Word while keeping them connected to SimplerQMS.
Search, Filtering, and Status Views
Locate deviation records using search, filters, and status-based views such as Active or Archived.
Deviation Management is Built into an Integrated eQMS
Deviation Management in SimplerQMS is supported within a broader, integrated eQMS for life science companies. Deviations can connect with related quality processes such as investigations, CAPA, and Change Control. For example, a deviation that requires corrective action can be linked to a CAPA, helping maintain continuity and traceability across the quality system. This gives teams better visibility and consistency across connected quality processes.
Explore our QMS Software
More Than Just Deviation Management
Beyond Deviation 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 Deviation 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 Deviation Management Resources
Explore practical insights and guidance on Deviation Management in regulated life science environments.
Deviation in the Pharmaceutical Industry: Definition, Types, and Management Process
DeviationsPharmaceutical
Frequently Asked Questions (FAQ) about Deviation Management
Find answers to common questions about Deviation Management and its role in life science quality management.
What is Deviation Management in SimplerQMS?
Deviation Management in SimplerQMS provides a structured process for capturing, assessing, investigating, and following up on planned and unplanned deviations. Teams can assign ownership, document findings and decisions, manage actions, and maintain supporting evidence and approvals in one connected workflow.
How Does Deviation Management Connect to Quality Events?
A deviation is one type of quality event managed in SimplerQMS. It can be created directly or escalated from an observation when QA determines that further investigation or follow-up is needed. Related records remain connected throughout the process.
Can a Deviation be Created from an Observation?
Yes. Employees can report a potential quality issue as an observation without first deciding whether it is a deviation. The Observation Inbox Owner can review the report and escalate it to a deviation when further investigation or follow-up is required.
Can I Link a Deviation to a CAPA?
Yes. If a deviation investigation identifies the need for corrective or preventive action, the related CAPA can be linked to the deviation. This helps maintain traceability from the original event through follow-up actions.
How Does Deviation Management Support Post-Market Surveillance?
Deviation Management can support post-market activities when a deviation is relevant to product quality or safety. Teams can document assessments, evidence, investigation findings, and follow-up actions to support further regulatory evaluation where applicable.
How Does Deviation Management Support Traceability?
SimplerQMS keeps deviation records, investigation findings, evidence, decisions, approvals, actions, and related CAPAs connected. This helps teams follow the history of a deviation without recreating information across disconnected systems.
See SimplerQMS in Action
See how SimplerQMS supports Deviation Management and other interconnected quality processes in a single, integrated eQMS.
