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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 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.
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 2025, starting with ComplianceQuest.
Introduction: A Before-After Story Imagine being a quality manager at a global medical device company. Each investigation—whether for CAPA, nonconformance,…
Proper complaint management is critical for detecting and resolving product or service shortcomings. Complaint management is also a compliance requirement…
In drug manufacturing quality control, a robust, well-defined testing and lab investigation process is critical to ensure that the drug…
The key features of the ComplianceQuest Investigation Management Software include:
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.
Case Management: Offers comprehensive case management capabilities, allowing users to track and manage multiple investigations simultaneously
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.
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.
Step 2: Gather Data
Root cause analysis should be based on data such as:
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.
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:
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.
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.
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.
A clear understanding of the event, including details such as where, what, and when should be elucidated clearly, briefly, and accurately.
Step 2: Gather Dat
Step 4: Assess Impact and Risks
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
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.
Identification & Assessment of Out-Of-Specification (OOS) Test Results – Laboratory Investigation checklist
Checklist | July 12th, 2022
A checklist on Full scale OOS Investigation – Production (Part A)
A Checklist on Full-scale OOS Investigation – Retesting & Resampling (Part B)
A Checklist on Full scale OOS Investigation – Reporting Test Results
A Checklist to Conclude OOS Investigation
A Step-by-Step Guide For Risk Management In Clinical Investigation Process, Medical Devices
Checklist | November 16th, 2021
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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