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  Lab Investigation  >  Investigation Management Software

Investigation Management Software

Investigation Management Software optimizes the investigation process by providing tools for case tracking, evidence management, and reporting.

This software enhances efficiency and accuracy, enabling organizations to handle investigations with greater transparency and compliance

Investigation Management Software
Investigation Management Software
Investigation Management Software Video

What is Investigation Management Software?

Investigation Management Software is a specialized tool designed to refine and automate managing investigations within an organization. It enables users to track, document, and analyze investigation activities efficiently, ensuring compliance with regulatory standards. The software offers features such as case management, evidence tracking, reporting, and data analysis to improve the accuracy and effectiveness of investigations. By centralizing investigation-related data, it enhances collaboration and communication among team members. Ultimately, it helps organizations to resolve incidents more quickly and prevent future occurrences.

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Top 10 Best Investigation Management Software in 2024

Investigation management software has become crucial for organizations aiming to refine their processes, secure compliance, and enhance overall efficiency. Here are the top ten investigation management software solutions in 2024, starting with ComplianceQuest.

  • ComplianceQuest
  • ComplianceQuest will be the leading AI-infused investigation management software in 2024. Its comprehensive suite of tools is designed to refine compliance processes, enhance collaboration, and secure regulatory adherence across various industries. The software's user-friendly interface, robust analytics, and customizable workflows make it an indispensable asset for businesses aiming to maintain the highest quality and compliance standards.
  • Enablon
  • Enablon offers a powerful investigation management solution that integrates seamlessly with other EHS and risk management modules. Known for its extensive reporting capabilities and intuitive dashboard, Enablon helps organizations efficiently track incidents, conduct thorough investigations, and implement corrective actions to prevent future occurrences. Its scalability and flexibility cater to the needs of both small enterprises and large corporations.
  • Intelex
  • Intelex provides a versatile investigation management system that emphasizes user experience and adaptability. With features like automated notifications, root cause analysis, and comprehensive audit trails, Intelex enables organizations to manage incidents effectively and maintain compliance with industry standards. Its cloud-based platform secures easy access and collaboration across various departments and locations.
  • MetricStream
  • MetricStream is renowned for its integrated risk and compliance management solutions and investigation management module, which are key components. The software facilitates the systematic recording, tracking, and resolution of incidents, ensuring a proactive approach to risk management. MetricStream's advanced analytics and reporting tools provide valuable insights, helping organizations make informed decisions and continuously improve their processes.
  • SAP EHS Management
  • SAP EHS Management offers a robust investigation management solution as part of its comprehensive environmental, health, and safety suite. Leveraging SAP's powerful analytics and integration capabilities, this software helps organizations manage incidents, conduct investigations, and implement corrective actions efficiently. Its seamless integration with other SAP modules secures a unified compliance and risk management approach.
  • Sparta Systems TrackWise
  • TrackWise by Sparta Systems is a highly regarded investigation management software known for its flexibility and scalability. It enables organizations to refine their investigation processes, secure regulatory compliance, and enhance efficiency. With features like automated workflows, root cause analysis, and CAPA management, TrackWise supports continuous improvement and operational excellence.
  • SAI360
  • SAI360 offers a comprehensive investigation management solution that integrates seamlessly with its broader risk and compliance platform. The software provides tools for incident reporting, investigation tracking, and root cause analysis, helping organizations maintain a proactive stance on risk management. SAI360's intuitive interface and robust analytics capabilities make it a preferred choice for businesses across various industries.
  • AssurX
  • AssurX delivers a versatile investigation management system emphasizing flexibility and customization. With its powerful workflow automation, incident tracking, and root cause analysis tools, AssurX helps organizations refine their investigation processes and secure compliance with industry regulations. Its user-friendly interface and robust reporting capabilities provide valuable insights for continuous improvement.
  • Gensuite
  • Gensuite offers a comprehensive investigation management solution as part of its integrated EHS and compliance platform. The software facilitates the efficient recording, tracking, and resolution of incidents, enabling organizations to maintain compliance and mitigate risks effectively. Gensuite's advanced analytics and reporting tools provide actionable insights, supporting data-driven decision-making and continuous improvement.
  • Incident Tracker
  • Incident Tracker helps manage incidents by categorizing digital forms and offering cloud-based solutions. It is used by security firms, educational institutions, and healthcare agencies to maintain a comprehensive record of incidents and ensure prompt action.

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Key Features of Investigation Management Software

The key features of the ComplianceQuest Investigation Management Software include:

Features of ComplianceQuest Investigation Management Software

  • Incident Reporting: Allows for quick and accurate reporting of incidents, with customizable forms to capture all necessary details.

  • Automated Workflows: refine the investigation process with predefined workflows, ensuring consistency and efficiency in handling incidents.

  • Root Cause Analysis: Provides tools for conducting thorough root cause analyses, helping to identify the underlying causes of incidents.

  • Corrective and Preventive Actions (CAPA): Facilitates implementing and tracking corrective and preventive actions to address issues and prevent recurrence.

Features of Investigation Management Software

  • Case Management: Offers comprehensive case management capabilities, allowing users to track and manage multiple investigations simultaneously.

  • Real-time Notifications and Alerts: Sends automated notifications and alerts to relevant stakeholders to inform them about the investigation status and required actions.

  • Document Management: Centralizes the storage and management of investigation-related documents, ensuring easy access and version control.

  • Incident Reporting: Allows for quick and accurate reporting of incidents, with customizable forms to capture all necessary details.

  • Automated Workflows: refine the investigation process with predefined workflows, ensuring consistency and efficiency in handling incidents.

  • Root Cause Analysis: Provides tools for conducting thorough root cause analyses, helping to identify the underlying causes of incidents.

  • Corrective and Preventive Actions (CAPA): Facilitates implementing and tracking corrective and preventive actions to address issues and prevent recurrence.

  • Case Management: Offers comprehensive case management capabilities, allowing users to track and manage multiple investigations simultaneously

  • Real-time Notifications and Alerts: Sends automated notifications and alerts to relevant stakeholders to inform them about the investigation status and required actions.

  • Document Management: Centralizes the storage and management of investigation-related documents, ensuring easy access and version control.

Different Methods Associated with Incident Investigation and Usage of 5 Why Methodology

Benefits of Investigation Management Software

  • Enhanced Compliance: secures adherence to industry regulations and standards, reducing the risk of non-compliance penalties.
  • Improved Efficiency: refine the investigation process through automated workflows, reducing manual efforts and time consumption.
  • Better Data Management: Centralizes incident data, making it easier to access, analyze, and report on investigations.
  • Root Cause Analysis: Facilitates thorough root cause analysis, helping to identify underlying issues and prevent future incidents.
  • Automated Notifications: Provides automated alerts and reminders to keep the investigation process on track and secure timely resolutions.
  • Comprehensive Reporting: Offers robust reporting tools that generate detailed, customizable reports for better insights and decision-making.
Investigation Management Software Benefits
investigation and root cause case study

Tips for a Better Investigation and Root Cause: Going Deeper than Human Error

investigation and root cause case study
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How to Make the Investigation Process Efficient?

The OOS can occur due to many factors. Therefore, it is important to follow a step-by-step approach to investigate the OOS results. The OOS investigation should happen in two phases. In Phase I, the effort is to ensure that the OOS result is not due to laboratory errors such as poorly calibrated equipment.

If the result does not attribute the cause to laboratory error, then a retest should be performed to be doubly sure. If the original result is confirmed, then a full-fledged Phase 2 investigation of the manufacturing process should be conducted.

OOS is just one type of event that needs to be investigated. An investigation management software such as ComplianceQuest can be used for different investigations, including non-conformance, complaints, and incidents.

An efficient investigation includes a seven-step process.

investigation management software incident event

Step 1: Define the Event

A clear understanding of the event, including details such as where, what, and when should be elucidated, briefly, and accurately.

gather investigation management data

Step 2: Gather Data

Root cause analysis should be based on data such as:

  • Part Numbers
  • Organization and personnel’s responsibilities for management, sponsor, study director, principal investigator, and study personnel are determined.
  • Lot numbers
  • Environmental conditions
  • People involved
  • Training records
  • Batch records
  • Notebooks, labels, and measured material associated with the event
rca for investigation management

Step 3: Perform Root Cause Analysis (RCA)

There are several approaches available to perform root cause analysis once the data is collected . 5 Why, Fishbone diagram, Pareto chart, scatter plot diagram, and Failure Mode and Effects Analysis (FMEA) are among the popular ones.

risk impact investigation management software

Step 4: Assess the Impact and Risks

On determining the root cause, assess the risks and impact on the quality and safety systems. To assess risks, one of the following methods may be used:

  • Failure mode and effects analysis (FMEA)
  • Fault tree analysis (FTA)
  • Hazard analysis and critical control points (HACCP)
  • Hazard operability analysis (HAZOP)
  • Preliminary hazard analysis (PHA)

The risks must be ranked on a risk matrix according to the severity, likelihood, and detectability as high, medium, or low. This will help prioritize mitigative efforts and improve quality and safety.

capa with investigation management software

Step 5: Initiate CAPA and Document Changes

Eliminating the cause of the error/incident/non-conformance is the next step, following and identifying the root cause. It is also important to initiate preventative actions (PAs) to prevent a similar event from recurring in the future. The CAPA action executed should also be documented and managed.

investigation management software effectiveness review

Step 6: Review Effectiveness Periodically

CAPAs require periodic reviews and effectiveness checks to ensure that the event’s root cause has been efficiently addressed and the event is not recurring.

  • investigation management software incident event

    Step 1: Define the Event

    A clear understanding of the event, including details such as where, what, and when should be elucidated clearly, briefly, and accurately.

  • gather investigation management data

    Step 2: Gather Dat

    Root cause analysis should be based on data such as:

    • Part numbers
    • Organization and personnel’s responsibilities for management, sponsor, study director, principal investigator, study personnel are clearly determined
    • Lot numbers
    • Environmental conditions
    • People involved
    • Training records
    • Batch records
    • Notebooks, labels, and measured material associated with the event
  • rca for investigation management

    Step 3: Perform Root Cause Analysis (RCA)

    There are several approaches available to perform root cause analysis once the data is collected . 5 Why, Fishbone diagram, Pareto chart, scatter plot diagram, and Failure Mode and Effects Analysis (FMEA) are among the popular ones.

  • risk impact investigation management software

    Step 4: Assess Impact and Risks

    On determining the root cause, assess the risks and impact on the quality and safety systems. To assess risks, one of the following methods may be used:



    • Failure mode and effects analysis (FMEA)
    • Fault tree analysis (FTA)
    • Hazard analysis and critical control points (HACCP)
    • Hazard operability analysis (HAZOP)
    • Preliminary hazard analysis (PHA)

    The risks must be ranked on a risk matrix according to the severity, likelihood, and detectability as high, medium, or low. This will help prioritize mitigative efforts and improve quality and safety.

  • capa with investigation management software

    Step 5: Initiate CAPA and Document Changes

    Eliminating the cause of the error/incident/non-conformance is the next step, following and identifying the root cause. It is also important to initiate preventative actions (PAs) to prevent a similar event from recurring in the future. The CAPA action executed should also be documented and managed.

  • investigation management saoftware effectiveness review

    Step 6: Review Effectiveness Periodically

    CAPAs require periodic reviews and effectiveness checks to ensure that the event’s root cause has been efficiently addressed and the event is not recurring.

ComplianceQuest delivers!

I’ve been using ComplianceQuest (CQ) for about 9 months and am extremely pleased with the product, the implementation team and ongoing support. I selected CQ for a number of reasons. Functionality and a simple user interface were key requirements. CQ has all the functionality needed in support of a global QMS. Implementation includes; Document control, change order, personnel training, NC/CAPA, equipment management, supplier management, audit management, and customer complaints all on a single platform. As a small biologics company it was critical to find a single solution to meet our GMP quality system requirements. We wanted a cloud-based system, that would be quick to implement, that could be expanded globally and in other languages, all for a reasonable price. The user interface – it is exactly what I was hoping for. I constantly hear the staff saying, “I love CQ, it’s so straightforward to use”.

The implementation team has met all my expectations. The CQ product ‘out of the box’ meets the majority of my requirements. With some minor configurations we have developed QMS workflows that are highly efficient and robust. A risk-based validation plan also allowed us to move quickly through the foundational functions; Controlled Documents, Change Order, and Personnel. The implementation team offer many industry best practices as solutions to questions and are also highly competent in listening to your requirements and doing whatever is necessary to fulfill them. Customer Support is incredibly timely in their responsiveness; addressing most questions or concerns within 24-48 hours, meanwhile communicating along the way. We are extremely happy with our selection and highly recommend ComplianceQuest.

Donna Matuizek,
Sr. Director Quality

just logo
just logo

How CQ’s Investigation Management Software Works

The typical reasons why OOS investigations are inadequate and do not meet FDA’s requirements include:

  • Investigations not performed promptly

  • Root causes not being identified appropriately

  • Not all potentially affected batches are being investigated

  • CAPA not being implemented

  • The effectiveness of CAPA not being evaluated

Often this is due to the implementation of manual investigation methods that make it difficult to cover the scope of the investigations on time, thoroughly, and take follow-up action. Document and change management can also be challenging.

ComplianceQuest’s cloud-based quality and safety solution integrates investigation management for different needs such as incident management, non-conformance, complaints, and OOS. It integrates with CAPA, document management, change management, and risk management, thereby facilitating a holistic approach to investigation management. A root cause analysis tool with a 5 Why methodology also helps to identify the root cause using a collaborative approach easily and effectively.

Further, solutions such as Management Review help review progress, assign responsibilities, and ensure everything planned is executed correctly.

Investigation Management Software aligns with all major regulations, thereby improving compliance and facilitating QA and QC teams to ensure guidance by providing pre-built workflows and customizable checklists.

While ensuring systematic, comprehensive, and efficient investigations, Investigation Management Software also offers collaboration tools and guided workflows that help QC and QA teams identify the root cause of every OOS test result, respond in a timely way, and remain compliant with thorough documentation. Whenever necessary, CQ’s lab investigation solution allows laboratory teams to initiate a Phase II investigation, conduct a full production review, and escalate to a CAPA if needed. It ensures high-quality products that conform to specifications.

ComplianceQuest Investigation Management Software facilitates implementing a consistent process with guided workflows to increase efficiency and minimize errors. This results in faster, more comprehensive investigations and reduced costs.

Automating OOS investigation with CQ also helps with document management. It increases compliance with regulatory and quality standards such as GLP, ISO, or other regulatory authorities and standards that require a consistent, thorough, and well-documented investigation process. Customizable printout formats for lab investigation plans and records of findings can be easily shared with investigators while maintaining the privacy of proprietary information.

Notifications and alerts prompt employees to perform their tasks on time, and communication and collaboration even across sites become easy because of the cloud-based system.

Overall, the ComplianceQuest Investigation Management Software helps with continuous improvement to reduce errors and events and spur growth.

Manage your entire Investigation process with ComplianceQuest’s Investigation Management Software for systematic, comprehensive, and efficient investigations

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Related Checklists

Quality-centric Companies Rely on CQ QMS

  • affinivax mono
  • verily mono
  • 3m logo mono
  • tupperware mono
  • continental logo mono
  • vyaire mono
  • lifescan mono
  • lundbeck mono
  • cdc logo mono
  • qlik mono
  • csa group mono
  • impossible mono
  • fluence mono

Frequently Asked Questions

  • Investigation management software streamlines and enhances investigative processes by centralizing case information, automating workflows, and improving collaboration. It ensures efficient data collection, analysis, and documentation, reducing manual errors and redundancies. The software provides a secure and organized platform for managing evidence and facilitating compliance with legal and regulatory requirements. Automated reporting tools offer real-time insights, enhancing decision-making.

    Additionally, investigation management software improves accountability, transparency, and auditability. It is an indispensable tool for organizations across various sectors, including law enforcement, corporate security, and regulatory compliance, seeking to optimize their investigative processes and mitigate risks effectively.

  • All investigations, be it for complaints, non-conformance, incidents, or OOS, are governed by regulations. For instance, the regulatory requirements for OOS investigations are detailed under Section 21 CFR 211 of Current Good Manufacturing Practice for Finished Pharmaceuticals and include:

    • 211.84 Components, product containers, and closures need to be tested and approved or rejected based on results

    • 211.113 Microbiological contamination needs to be controlled

    • 211.160 Lists general requirements

    • 211.165 Covers the testing and release for distribution

    • 211.194 Lays requirements for laboratory records of testing and validation, ensuring the conforming of components, containers and closures, in-process materials, and finished products to specifications.

    ComplianceQuest Investigation Management Software is built to align with the major regulations and standards such as FDA, MDR, and ISO. As a result, implementing the solution helps organizations become compliant. The workflows are automated, making it easy to keep pace with changes in regulations and also cater to the local regulatory needs of different geographic locations.

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