Lab Investigation  >  Investigation Management Software

Investigation Management Software

Investigation Management Software
Investigation Management Software
investigation management software video

Between 2017 and 2022, 21 CFR 211.192 – Investigations of discrepancies – was the second highest reason for US Food and Drug Administration issuing warning letters to companies at 523. Insufficient documentation of the investigation was one of the causes for the organizations receiving the letter.

Investigation of Out of Specification results is a regulatory requirement and requires an efficient Investigation Management Software to:

  • Control the tasks
  • Control information flow
  • Manage the stakeholders involved in the investigation

Investigation Management Software covers managing the evidence, team members, witnesses, and processes such as deadlines and workflows.


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introduction to investigation management software

Introduction to Investigation Management Software

To ensure patient safety and product quality, the FDA requires life sciences companies to investigate any deviations from specifications laid out during the design stage. It requires the root cause of the problem to be identified and corrective and preventive action to be taken. Root cause analysis helps to determine whether all the batches of a product and all the products associated with the process are defective. This helps to prevent a defective batch or product from being released into the market. Also, it helps address the defect promptly to prevent the deviation from recurring in the future.

Since the manufacture of a drug involves many processes from design to delivery, it needs an efficient investigation management software that helps improve compliance, documentation, root cause analysis, and CAPA. In addition to keeping patients safe, addressing deviations helps the company protect its brand reputation and avoid being issued warning letters by the FDA. Product recalls can be minimized, also affecting savings for the company in billions.

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

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 clearly, 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, 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 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.

Benefits of Investigation Management Software

Event investigation is a regulatory requirement for many types of events such as OOS, non-conformance, safety incidents, and complaints across industries.

The investigation aims to identify the root cause of a problem and address it effectively to correct it and prevent its future recurrence.

This entire process needs to be documented. Every change introduced to correct the root cause needs to be assessed for its impact on the processes.

The CAPA impact also needs to be reviewed periodically to ensure it is effective and the problem is not recurring, on the one hand, and a new problem has not been introduced, on the other.

With so many variables involved, manually tracking, correcting, and checking can become challenging and not provide a holistic picture. This can limit the benefits of identifying the root cause during the investigation.

Evaluating the effectiveness of CAPA becomes easier through automation. Automating the investigation process helps to standardize it, ensuring consistency and robustness. Investigation Management Software helps with complete documentation and change management by providing visibility and traceability. Investigation Management Software can also help businesses take a risk-based approach and mitigate high-priority risks effectively and efficiently.

As businesses improve their CAPA and reduce events, their profitability and brand reputation also increases.

benefits of investigation management software
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 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 integrate 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 to 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, comprehensive investigations and reduced costs.

Automating OOS investigation with CQ also helps with document management. It increases compliance to 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.

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

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just logo

Key features of Investigation Management Software

The key features of the ComplianceQuest Investigation Management Software include:

  • Attachment: to attach images and tables along with investigation plans etc.

  • Impacted Batch: Refer impacted batch for full traceability

  • Field Alert Assessment: Get reminders in case the OOS result is for stability testing

  • Integrated Risk Management: Embedded risk assessment in lab investigation record

  • Escalate to NC: Launch NCs and actions directly from the investigation record and link records together

  • Customized Printouts of Lab investigation reports

  • Phase 1 and Phase 2 investigation and escalation as needed

  • Access to pre-built checklists

  • Generate reports and dashboards

  • Communicate and collaborate with team members

  • Get automated alerts and notifications

  • Set up workflow and approval matrix queues

  • Attachment: to attach images and tables along with investigation plans etc.

  • Impacted Batch: Refer impacted batch for full traceability

  • Field Alert Assessment: Get reminders in case the OOS result is for stability testing

  • Integrated Risk Management: Embedded risk assessment in lab investigation record

  • Escalate to NC: Launch NCs and actions directly from the investigation record and link records together

  • Customized Printouts of Lab investigation reports

  • Phase 1 and Phase 2 investigation and escalation as needed

  • Access to pre-built checklists

  • Generate reports and dashboards

  • Communicate and collaborate with team members

  • Get automated alerts and notifications

  • Set up workflow and approval matrix queues

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

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Quality-centric Companies Rely on CQ QMS

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Frequently Asked Questions

  • 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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