Compare the Top CAPA Software as of December 2024

What is CAPA Software?

CAPA (Corrective and Preventive Action) software helps organizations identify, manage, and resolve issues that affect product quality or compliance by tracking corrective and preventive actions. It streamlines the process of investigating root causes, implementing corrective actions, and preventing future occurrences, ensuring continuous improvement in operations. The software automates tasks like incident reporting, workflow management, and documentation, allowing for more efficient handling of quality and compliance issues. CAPA software also provides detailed reporting and audit trails to support regulatory compliance and enhance accountability. Overall, it helps businesses improve product quality, reduce risks, and maintain compliance with industry standards. Compare and read user reviews of the best CAPA software currently available using the table below. This list is updated regularly.

  • 1
    HSI Donesafe
    Turn obstacles into growth opportunities with HSI Donesafe’s CAPA Software. Simplify corrective and preventive actions using intuitive tools designed for speed, transparency, and collaboration. Ensure issues are addressed promptly, minimizing disruptions and developing a proactive risk management approach. Empower your team to resolve challenges efficiently, focusing on continuous improvement. Discover true configurability with our no-code platform. Simply change what you need when you need with our easy-to-use drag and drop function. By promoting accountability at every level, Donesafe cultivates a culture of learning and resilience. Setbacks become progress when you create a future where safety, operational success, and continuous improvement go hand in hand, driving long-term growth and safety outcomes.
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  • 2
    Intelex

    Intelex

    Intelex Technologies

    Intelex is an integrated software solution for managing Environmental, Health, Safety and Quality (EHSQ) programs. Intelex’s scalable platform is designed to store, manage and analyze EHS and Quality data in one place. The solution works on any device to meet the realities of your workplace. With Intelex, your organization can: - Drive better results in your EHSQ program by monitoring workflows to achieve top performance and gain control. - Identify trends and tendencies by setting goals to gain greater insight into your EHSQ program to enhance judgement. - Reduce incidents and administrative work by easily monitoring, managing, optimizing and drawing insights from your safety data with our user-friendly safety software solution. - Streamline air, water and waste emissions management and reporting, and track and manage environmental outputs to achieve sustainability goals. - Drive continuous quality improvement activities across multiple departments, sites or locations.
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  • 3
    ReliaSoft

    ReliaSoft

    Hottinger Brüel & Kjær (HBK)

    ReliaSoft software provides a powerful range of reliability software solutions to facilitate a comprehensive set of reliability engineering modeling and analysis techniques. We are the leading reliability solution provider for product test, design, maintenance strategy and optimization. Our products support a wide range of reliability and maintainability analysis techniques, such as life data analysis, accelerated life testing, system modelling and RAM analysis, reliability growth, FRACAS, FMEA and RCM analysis to meet and improve reliability of your products, processes and optimize maintenance planning.
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  • 4
    isoTracker Quality Management

    isoTracker Quality Management

    isoTracker Solutions Ltd

    isoTracker Quality Management is a popular cloud-based quality management software (QMS) that is used by small to medium sized businesses on a worldwide basis. It helps to manage ISO 9001, ISO 13485, ISO 22000, ISO/IEC 17025, ISO 14001, ISO 45001, ISO/TS 16949, ISO 14971 systems...plus many other systems. It also conforms to the requirements of 21 CFR Part 11. It is a flexible and modular product with modules in document control, audit management, non-conformance management, customer complaints management, risk management, training management and CAPA management. It can be configured to meet an organization's specific needs and provides free training and free support. It has been independently judged to provide the best customer support in its category.
    Starting Price: $13.96 USD/month/user
  • 5
    TenForce

    TenForce

    TenForce

    Complete EHSQ solution designed for manufacturing, utility and government organizations that allows plant managers to track, analyze and report on their EHSQ processes. Our solution automates workflows, centralizes data and simplifies collaboration. TenForce offers various integrated modules to help streamline processes such as Audits, Incident Management, Lockout/Tagout (LOTO), Permit to Work, Management of Change, and Shift Management. It offers mobile capabilities, which allow field workers and inspectors to access the software on mobile devices. Its built-in data analytics and reporting functionality enables managers to gain insights into the processes and risks of their industrial plants or public infrastructure assets. This visibility helps them address environmental, health, safety, quality, and compliance issues. TenForce helps manufacturers optimize their established processes while minimizing incidents.
    Starting Price: $9000 per year
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  • 6
    Artintech ERP

    Artintech ERP

    Artintech

    Artintech ERP’s Non-Conformance module is vital to our Quality Management System (QMS) solution, providing a robust and comprehensive tool for managing non-conformance events. Our software features NCR, CAPA, RCCA, and Disposition functionalities, allowing you to manage and analyze non-conformance trends and performance metrics easily. With comprehensive reporting features, our software streamlines your non-conformance management processes, providing a simple, intuitive interface that minimizes the time and resources required for effective control. Choose Artintech ERP as a part of our QMS solution for efficient and effective non-conformance management.
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    Starting Price: $24.95/Module/Month
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  • 7
    Certainty Software

    Certainty Software

    Certainty Software

    Improve Performance and Sustainability with Certainty! Certainty is an enterprise-level software solution to easily collect and report inspection data and manage issues identified. Used by hundreds of thousands of professionals to complete millions of audits and inspections annually, Certainty helps companies around the globe ensure compliance, reduce risk, and improve performance with easy-to-use forms, real-time reports, and complete action management. Collect, track, and report accurate and powerful data to provide detailed business insights that will empower your team to improve performance and business sustainability. Certainty is used worldwide for: Safety inspections Quality assurance and control audits Supplier and supply chain compliance audits ESG assessments And much more . . .
    Starting Price: $18 per user per month
  • 8
    Total Lean Management (TLM) Software

    Total Lean Management (TLM) Software

    Lean & Mean Business Systems

    Perfect for a small company, TLM has everything you need, and can accelerate the implementation with consulting, training, procedure templates, and document writing/coaching support, plus we have validation templates and a system setting mode so small medical device companies have special features to help manage technical files and 510K submittals. TLM QMS Software saves you money AND makes your QMS more effective by providing a dual technology landscape for the two distinct QMS user types. Core modules include: • Audits • Contact Manager (CRM) • CAPA • Customer Feedback • Document Management • Electronic Forms • Employees • Employee Feedback • Equipment Calibration • Evaluations • FMEA • Inspections • Inventory/parts • Library • Meetings/Reviews • Metrics • Projects • Purchase Orders • Quality Record Mgt • Rejected Materials • Risk & Opportunities • Sales Orders • Strategic Planning • Surveys • Tasks/Events • Training • Work Orders
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    Starting Price: $45/user/month
  • 9
    qmsWrapper

    qmsWrapper

    qmsWrapper

    qmsWrapper is an interconnected Quality Management Software for startups and small businesses. It helps all companies that want to increase productivity with ISO 9001:2015 and MedDev creators to easily achieve and manage ISO 13485:2016 and 21 CFR 820. At qmsWrapper, we cater to each industry’s unique quality management needs with tailored features: Compliance Made Easy: Adhere to standards like ISO 13485 and ISO 9001 effortlessly, maintaining a robust QMS. Risk Management: Simplify risk assessment with ISO 14971-compliant tools, effectively mitigating risks. Document Control: Intuitively manage documents for enhanced traceability and version control. Cloud-Based Accessibility: Access your QMS anytime, anywhere. Electronic QMS: Embrace efficiency with digitized QMS for faster approvals and real-time updates. Audit Management: Prepare for audits confidently with scheduling, tracking, and reporting tools.
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    Starting Price: $250/month/10users
  • 10
    CAPA Manager

    CAPA Manager

    Adaptive Business Management Systems

    Automate the identification, containment, investigation, and resolution of problems within your organization and supply chain. Trusted by thousands of users globally, this is one of the best CAPA software applications available. CAPA Manager corrective action software automates the assignment, notification, investigation, reporting, and approval of corrective actions. It error-proofs the control of the entire CAPA process, from initiation to investigation and all the way through to closure. CAPA Manager meets the requirements of all important quality management standards: 21 CFR part 11, ISO 9001, AS9100, TS 16949, and more. It keeps records of root-cause and corrective action while providing pre-defined workflows and approval gates.
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    Starting Price: $12.49 per user/month
  • 11
    Clearity

    Clearity

    Clearity

    Clearity.io is a security compliance management application that provides covered entities, business associates, and their partners the ability to measure their security program by conducting self-assessments, managing corrective action plans, and working towards industry-driven compliance while viewing real-time data on our dashboard. Does your risk and compliance intelligence come from pages and pages of paper-based reports? How much time do you spend manually creating or combing through spreadsheets and PDFs from 3rd party vendors? If this is your organization, it’s time to automate that process. Clearity gives you the ability to feel in control of your security risks and to know what work needs to be completed. As you head down that road, visually see your risks diminish over time. Create your own HIPAA, HIPAA (Vendors), CSC, NIST CSF, or NIST 800-53 Security Assessments. Work on them on your own time.
    Starting Price: $99 per month
  • 12
    Qualityze EQMS Suite
    Qualityze is a leading provider of enterprise quality management solutions, utilizing the Salesforce.com Technology Platform to build our EQMS Software solutions. Our team is 100% devoted to quality processes, compliance, and regulatory guidelines to address our customers' business environments. We do not distract ourselves with custom work or quality concerns. The idea of helping our customers create a culture of quality is not a new concept, but the way we developed our application, Quality Management Software, based on making it easy to use, intuitive, and inclusive. Therefore, the entire organization is involved in quality, not because they are told they should, but because it's easy, fun, and has a logical flow. We strive to optimize quality with excellence through our exclusive range of smarter quality management software solutions.
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    Starting Price: $30/User/Month
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    Intellect

    Intellect

    Intellect

    Intellect QMS is the latest version of Intellect's flagship product designed to help organizations and quality leaders meet FDA, ISO, and other global GxP regulatory compliance requirements. Intellect offers faster implementation time, robust out-of-the-box QMS capabilities, and extreme configurability to modify or build new apps. Empower your onsite and remote workforce with virtual auditing, online approvals, 21 CFR Part 11 electronic signatures, and ensure your team can access only approved and up-to-date quality documents, data, reports and analytics anytime, on any device. Intellect’s Environmental, health, safety and quality (EHSQ) software acts as a data management system for capturing, storing, and analyzing information related to occupational health and safety, waste management, and sustainability. It aims at reducing operational risk and improving health while attaining sustainability goals.
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    Panotica Hydra 4.0
    Panotica Hydra is a modular QMS software for managing quality processes according to the requirements of ISO 9001, 14001, 18001 and other similar ones. The software allows not only to gather all of the company’s improvement processes in one system, but also to actively integrate all of the employees on the system platform. Hydra provides access to supervise activities remotely aimed at improving quality as well as engages company’s employees in the improvement process.
    Starting Price: $9 per user per month
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    ACE Essentials

    ACE Essentials

    PSC Software

    Reduce risk with ACE Essentials, the pre-validated Electronic Quality Management System (EQMS) software created for all highly regulated industries. ACE Essentials comes equipped with 10 workflows built in and all the necessary Standard Operating Procedures and Policies, resulting in a fully compliant quality management system from the beginning. Understand the risks associated with your assets with ACE Essentials features including a full audit trail tracking every single action in the system. Pre-Configured Workflows. Pre-Configured Event Management (Due Dates, Scheduling and Reminders). Pre-Configured Permission-Based Security. Full Documentation Pre-Configured. 50+ Documents. Multiple Site Capability. Free Upgrades Throughout the Life of the Product. Pre-Configured Tasks List. No Validation Time. Pre-Configured In-System Notifications. Pre-Configured Email Notifications
    Starting Price: $500 one-time payment
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    MasterControl

    MasterControl

    MasterControl

    Bringing breakthrough products to market in highly regulated industries can feel like an endless series of trade-offs. MasterControl's software simplifies GxP workflows so you never have to sacrifice quality for cost or innovation for regulation. Complete and connected meets fast and flexible. From quality event management to document control and integrated training - MasterControl Quality Excellence transforms your quality data and processes into a competitive advantage. Modernizing your manufacturing operations starts with modern software. From work orders to work instructions and production records (EBR or eDHR) to logbooks, MasterControl Manufacturing Excellence is the simplest way to digitalize manufacturing.
    Starting Price: $25,000 / 1st year
  • 17
    QT9 QMS

    QT9 QMS

    QT9 Software

    QT9's comprehensive cloud-based quality management software platform enables you to access real-time analytics in one unified suite. QT9 QMS makes it easy to automate ISO & FDA Compliance with 21 CFR Part 11 Electronic Approvals. Optimize processes for Document Control, CAPA's, Audits & More in one unified platform. Centralize records across multiple sites with ease. Never miss a deadline with automated email alerts/reminders. QT9 QMS makes quality management easy. Digitally transform Life Sciences, Biotechnology, Medical Device Manufacturers, Pharma, Aerospace and Food companies with user-friendly web portals for unlimited scalability. Get a free product tour! Start a Free Trial. Visit QT9qms.com
    Starting Price: $2,300/year
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    SBS Quality Database

    SBS Quality Database

    Sunday Business Systems

    The SBS Quality Database is a simple, inexpensive, ISO 9001 compliant software program that allows small businesses to efficiency manage the Quality Management System or QMS. The database tracks corrective actions, preventive actions (CAPA), internal audits, safety improvement, supplier corrective actions, continual improvement projects. Compile and analyze Customer Survey results. Identify and minimized risk using the risk management module (FMEA & SWOT analysis) . Document QMS review meetings and results. Document interested parties as part of the Context of the organization. Use the dashboard for a quick view of the overall performance. Cloud based or locally installed options are available. The program is ideal for small businesses striving for ISO 9001:2015, API Q1, AS9100, or TS16949 compliance. Free demo downloads are available from our website so you may try before your buy.
    Starting Price: $499/one-time
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    Dot Compliance QMS

    Dot Compliance QMS

    QMS for Life Sciences

    Dot Compliance provides the industry’s first off-the-shelf QMS solution – ready to deploy from day one, with little to no setup required, while also incorporating industry best practices and standards that address the latest global regulatory requirements. Powered by the Salesforce.com platform, our solutions enable life science organizations to quickly digitize their quality and compliance processes including Document Management, Training Management, Change Control, CAPA, Customer Complaints. Compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14971, 27001 & MORE! Processes included: ▶ Document Management ▶ Training Management ▶ Quality Event Management ▶ CAPA Management ▶ Change Management ▶ Complaint Management ▶ Audit Management ▶ Supplier Quality Management ▶ Risk Management ▶ Design Control ▶ Deviations/Non-conformances ✔ Seamless Install ✔ Cost Effective ✔ One-Stop-Shop
    Starting Price: $10,000 / Annually
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    SimplerQMS

    SimplerQMS

    SimplerQMS

    SimplerQMS offers a cloud-based Quality Management Software that is fully validated according to GAMP5 and specifically designed for the Life Science industry. This comprehensive QMS platform helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, ICH Q10, and others. The software offers a wide range of Life Science QMS modules, such as Document Control, Change Management, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs, among others, ensuring a seamless experience. SimplerQMS enhances document handling by allowing users to work directly in Microsoft Office applications like Word, PowerPoint, and Excel.
    Starting Price: $13,750/year
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    SBS Quality Management Software Suite
    The SBS Quality Management Software Suite (QMS Suite) is a group of 5 software modules that work together for efficient Quality compliance. The QMS Suite can be deployed on your local server or accessed from our cloud server. Each module is designed for ease-of-use to reduce training overhead and improve overall compliance. Password controlled access and privileges ensure you may control access to critical features for each user. The SBS QMS Suite of modules: SBS Quality Database - CAPA / 8D with root cause analysis - Nonconformance management - Risk analysis (FMEA, SWOT, risk register) - Audit management SBS Ground Control - Employee training management (LMS) - Document control SBS Asset Tracking Database - Calibrated equipment - Preventive maintenance SBS Inspection Database - Data collection / SPC - Control Plans SBS Vendor Management - Approved vendor list / AVL - Supplier qualification plans Great product for efficient and affordable QMS Compliance.
    Starting Price: $4,268
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    Cognidox

    Cognidox

    Cognidox Ltd

    Cognidox is an online document management system for high-tech, medical device and life sciences product development sectors. Available in the cloud or as an on-premise solution, Cognidox promotes better product lifecycle management and knowledge transfer from developers to clients, partners, and customers. Secure and reliable, Cognidox provides plug-ins for various programs such as Microsoft Office, and we also offer a robust API so that you can integrate almost any process with Cognidox In addition to the core function as a DMS, an add-on for Cognidox also offers a way of allowing licensing and distribution of documents to third parties via fully sandboxed site so you have the power to publish specific documents whilst keeping your main storage secure. Another popular add-on is the gBMS - graphical Business Management System, Use Visio to easily capture your business processes, a good BMS should give you clear oversight of your entire operation.
    Starting Price: £10 p/user
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    VelocityEHS

    VelocityEHS

    VelocityEHS

    We deliver EHS management software that solves complex business challenges in simple ways. Our implementations are quicker, cost less and are more successful than traditional enterprise software systems. The real value of our solution is not the software itself, but how well it helps you do your job and achieve your goals — across departments, facilities, locations, and continents. Our true cloud solutions are simple enough for your frontline people to use on the fly, and sophisticated enough for you to run global, best-in-class programs — right out of the box. VelocityEHS brings together the industry’s most trusted solutions for managing risk, industrial hygiene, environmental concerns, hazards and incidents, training and much more. And we are the only source for MSDSonline chemical management and Humantech industrial and office ergonomics solutions. See why more than 18,000 customers worldwide trust us to simplify their complex compliance challenges.
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    BPAQuality365

    BPAQuality365

    BPA Solutions

    BPAQuality365 is a prebuilt QMS software to use in your secured Microsoft 365 cloud, leveraging tools used by collaborators daily, with no need to change user habits. It’s modern, compliant with any device, flexible to match your unique needs, and powered by innovative M365 technologies. The app includes powerful compliance document management, audit, non-conformance, CAPA action, risk, equipment, health, safety, environment modules compliant with ISO 9001, FDA Part 11 and medical regulations. The QMS app is closely integrated to discussion flows in Teams and enable instant quality improvement. Go a step further and reach your Quality 4.0 objectives by combining powerful AI features, best-in-class workflow automation, business intelligence and mobile Power Apps to run on any device. Benefit from BPA’s Microsoft Preferred status to configure your QMS to your needs, transfer knowledge to your power users and get trained on M365 technologies.
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    SansWrite

    SansWrite

    SansWrite

    SansWrite is a cloud-based compliance monitoring platform that automates inspections and corrections, and provides access to compliance data for trend analysis and government transparency. In other words, SansWrite helps inspectors increase productivity, assists licensees with achieving and maintaining compliance, and informs communities about the care of loved ones. For more information, please visit www.sanswrite.com today.
    Starting Price: $399/user/year
  • 26
    Predator Software

    Predator Software

    Predator Software

    Since 1994, Predator Software focuses on automating manufacturers worldwide with innovative and award-winning software applications. Predator Software is an industry leader in Industry 4.0, lean manufacturing, industrial networking solutions and automation via shop floor control or SFC. Predator's SFC technologies include CNC networking, machine monitoring, OEE, production data management, data collection, machine simulation & verification, tool & gage crib management, traveler management, CNC post processing, flexible manufacturing systems and robotic cell control software.
    Starting Price: $250
  • 27
    MediaLab Intelligent Quality Engine (IQE)
    IQE is MediaLab’s non-conforming event management system that allows clinical laboratory teams to track, assess, and prevent non-conforming events (NCE). With the capability to import or create event forms and data logs, IQE enables laboratory teams to eliminate deficiencies, correct common NCEs, and, most importantly, focus on improving healthcare. With a MediaLab institutional subscription, administrators can easily document each phase of the event management lifecycle, from initial event description to risk analysis, investigation, and root cause analysis, corrective and preventive actions plans, and overall CAPA effectiveness evaluations. IQE supports: • Customizable, pre-built event forms and workflow • Monitoring and evaluating change control events, failed PT events, customer complaints / feedback, safety / injury events, supplier / vendor issues, and more • Tracking periodic data entries • Robust reporting and dashboards to identify common NCEs and CAPA effectiveness
  • 28
    ECAT

    ECAT

    Electronic Compliance Audit Tools

    ECAT, a cloud-based audit management solution, enables organizations to monitor, review and generate reports on safety inspections. ECAT offers key features such as offline mode, inspection scheduler, and multi-field inspections. ECAT helps organizations conduct inspections for hygiene, production, equipment, security, general safety and more.
    Starting Price: $40.00/month/user
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    EHS Insight

    EHS Insight

    EHS Insight

    EHS Insight is an environmental, health and safety (EHS) management platform that empowers organizations to ensure company-wide compliance. Affordable and quick to setup, EHS Insight offers the best value in EHS software today by providing businesses with the tools they need to manage incidents, audits and inspections, compliance obligations, corrective actions and more. EHS Insight also comes with fantastic support to assist businesses during and after software implementation.
    Starting Price: $200.00/month
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    IMEC Safety Management Software
    IMEC Safety Management Software, formerly Inspector, is a cutting-edge inspection and incident management software solution that is composed of two modules each with a mobile app. The Inspections module enables users to manage, schedule, track, and report on any type of inspection, including safety, equipment, and facilities in single or multiple sites. On the other part, the Incident Management module enables users to manage, report, and track hazards, incidents, and near misses. Checklists can also be used to capture Text Inputs, Numeric Inputs, Date Input, Signature Capture, GPS Location, QR Codes / Barcodes. QR Codes / Barcodes can be used to trigger the inspection to commence, the user simply scans the code of the item to be inspected and the inspection will start. A wide range of QR Codes / Barcodes are supported as standard.
    Starting Price: $12 per month
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Guide to CAPA Software

CAPA software is a comprehensive system that helps organizations ensure the quality of their products and services. It stands for Corrective and Preventive Action, and it provides an integrated suite of tools to help companies track and analyze data, implement corrective actions, monitor progress, and measure performance.

CAPA software has been designed to capture real-time process data such as product defects, customer complaints, non-conformances, audit findings, safety incidents, and other root causes. This data is then used to identify potential risks or areas of improvement in the organization’s processes or systems. Once identified, the CAPA software can be used to develop a corrective action plan that addresses those issues. The corrective action plan includes steps needed to be taken in order to resolve the issue or prevent it from happening again in the future.

The CAPA software also includes powerful reporting capabilities which make it possible for teams to measure their performance against established targets with meaningful metrics. This makes it easy for managers or key stakeholders to review how well their organization is doing in terms of risk management or regulatory compliance. The reports are highly customizable depending on what information you need access to in order to make decisions more quickly and accurately.

Ultimately, CAPA software helps organizations achieve high levels of product quality by providing them with detailed insight into their processes so they can effectively identify opportunities for improvement and take appropriate corrective action when required. By monitoring process metrics over time they are able to maintain consistent levels of quality assurance across all areas of their business while meeting industry standards or regulatory requirements at the same time.

Features Offered by CAPA Software

  • Report Generation: CAPA software allows organizations to generate reports that provide visibility into their corrective and preventive action programs. These reports help to identify trends in failures, as well as provide insight into areas for improvement. Reports can be generated on a wide range of topics, from root cause analysis to supplier performance.
  • Automated Notifications: CAPA software can be customized to send automated notifications when certain criteria are met. This helps ensure that appropriate personnel are notified of issues as soon as possible so that corrective actions can be taken quickly and efficiently.
  • Change Management: CAPA software provides an efficient way to manage change requests. It allows organizations to easily capture, track, and review the progress of changes within their system or process before they are implemented.
  • Problem Solving Tools: CAPA software includes a variety of problem solving tools such as fishbone diagrams, cause & effect diagrams, and 8D approaches which help organizations identify and analyze the root causes of problems within their processes or systems.
  • Risk Management Capabilities: CAPA software enables organizations to better assess risk associated with their operations by providing functionality for identifying potential risks and assessing the severity of those risks based on established criteria. It also supports efforts related to containment activities and nonconformance resolution processes.
  • Document & Task Tracking: CAPA software provides features for tracking tasks and documents related to corrective & preventive action programs so that everyone is aware of what needs to be done when it comes time for implementation or follow-up activities. This helps ensure that tasks don’t fall through the cracks giving organizations greater control over their corrective & preventive action programs.
  • Quality Dashboards: CAPA software also includes dashboards that provide a high-level overview of areas like corrective action trends and compliance status. This helps organizations quickly identify trouble spots so they can take appropriate measures to address them before they become bigger issues.

What Are the Different Types of CAPA Software?

  • Quality Management Software: Quality management software helps organizations ensure product quality by tracking and recording data regarding all aspects of the production process. It also helps to automate processes such as generating reports, scheduling audits, and maintaining compliance with standards.
  • Risk Management Software: Risk management software helps organizations identify risks before they become problems, allowing teams to take preventative action. Various features of this type of software can include data trends analysis, process control systems, incident reporting tools, real-time alerting and more.
  • Document Control Software: Document control software help’s organizations manage their documents in one central location while providing access controls for different individuals or groups. Features may include searchable document databases, workflow automation, web-based collaboration tools and more.
  • Training & Assessment Software: Training & assessment software helps organizations easily create tests for employee training and assessment purposes. With this type of software various tasks such as designing test questions; tracking employee progress; issuing certificates; and generating reports can be automated quickly and easily.
  • Corrective Action Tracking Software: This type of software helps organizations track corrective actions from start to finish. It allows users to record issues quickly; assign tasks to individuals; monitor actions in real time; capture evidence for auditors; and generate reports that provide visibility into the process.

Recent Trends Related to CAPA Software

  1. CAPA software is becoming increasingly popular as organizations strive to adhere to quality standards and regulatory compliance.
  2. The software enables companies to systematically identify, investigate, and resolve potential non-conformances.
  3. Organizations are recognizing the need for a comprehensive system that can track activities related to CAPA process lifecycle management.
  4. Companies are looking for solutions that can streamline the entire process, from root cause investigation to corrective action implementation.
  5. Automation of CAPA processes allows companies to reduce human error, eliminate manual data entry, and speed up the process of identifying non-conformances.
  6. CAPA software also makes it easier for organizations to access insights and analytics about their processes and performance in real-time.
  7. The trend towards cloud-based solutions is making CAPA software even more accessible and cost-effective.
  8. As the complexity of compliance regulations continues to increase, there is an increasing need for sophisticated CAPA software.

Benefits Provided by CAPA Software

  1. Robust Automation: CAPA software provides automated workflow capabilities that allow users to streamline the process of documenting and managing corrective actions. It also offers advanced analytics and reporting features that enable users to get an accurate view of their operations and identify opportunities for improvement.
  2. Comprehensive Regulatory Compliance: CAPA systems provide a unified platform for tracking, verifying, and auditing compliance activities across multiple industries and regulatory bodies. This ensures that your organization is in accordance with applicable regulations.
  3. Improved Data Quality: The advanced data-gathering features of a modern CAPA system provide detailed insights into operational performance, giving users greater visibility over the status of their corrective action program. This enables teams to quickly identify areas for improvement and generates more reliable data for decision making.
  4. Scalability & Flexibility: With its web-based architecture, CAPA systems are highly scalable and can be tailored to fit a wide range of needs. They integrate seamlessly with other enterprise software solutions such as ERP or CRM platforms, allowing organizations to leverage existing investments while still providing powerful corrective action capabilities.
  5. Faster Response Times: The intuitive design of modern CAPA systems makes it easy for users to quickly find information they need in order to make decisions or take corrective actions. This helps ensure that issues are addressed quickly, reducing organizational risk exposure due to potential noncompliance or safety issues.
  6. Comprehensive Audit Trails: CAPA systems create comprehensive audit trails that document every step of the corrective action process. This ensures that organizations can easily trace each initiative back to its origin and effectively monitor progress over time.
  7. Improved Quality Assurance: By giving users deeper insights into their operations, a modern CAPA system can help detect issues before they become bigger problems. This improves the quality of your organization's processes and products, providing added assurance for both customers and regulators.

How to Find the Right CAPA Software

  1. Identify your CAPA needs: Before selecting CAPA software, it is important to first identify the needs of your organization. Consider key areas such as root cause analysis, corrective action planning and implementation tracking, as well as compliance to industry regulations and standards.
  2. Gather stakeholders: To ensure that everyone is on board with the selection of the right CAPA software, it is important to gather all relevant stakeholders during this process. This includes members from different departments such as legal, quality assurance and IT teams.
  3. Research potential solutions: Once the need has been identified, research potential solution providers that offer CAPA software that will meet your requirements. Read customer reviews and ratings in order to get an idea of their reputation in the market place. Use the comparison engine on this page to help you compare CAPA software by their features, prices, user reviews, and more.
  4. Shortlist candidates: After researching potential solutions, create a shortlist of candidate vendors whose products meet your specific requirements for functionality and scalability.
  5. Request demos: Before making a decision, request demos from each vendor so you can evaluate firsthand how their product works and its compatibility with your other existing systems or processes.
  6. Select one solution: After researching and evaluating all available options, select one solution that best meets your needs for functionality, scalability, features and cost-effectiveness for both current-state use cases and future growth needs.

What Types of Users Use CAPA Software?

  • Quality Managers: Quality Managers are responsible for overseeing the quality assurance department, ensuring that all processes meet compliance standards and regulations. They use CAPA software to track non-conforming materials and components, investigate root causes of problems, implement corrective action plans, and report on the effectiveness of corrective measures.
  • Operators: Operators use CAPA software to document issues such as failed inspections, mislabeled products, or other quality concerns. They can also use it to report potential corrective actions needed in order to resolve the issue and keep production running smoothly.
  • Engineers: Engineers use CAPA software to analyze data from production processes in order to identify trends and potential issues with equipment or components. They can then develop corrective action plans based on their findings in order to prevent future production delays or losses due to quality issues.
  • Production Supervisors: Production Supervisors use CAPA software for a variety of tasks related to managing their production lines. This may include tracking performance metrics such as cycle time, yield rate, scrap rate, defect rate etc., analyzing data from process observations or inspections in order to evaluate efficiency and identify areas for improvement, implementing changes based on analysis results etc.
  • Suppliers: Suppliers sometimes use CAPA software for monitoring product quality across their supply chains by having access to customer complaints or returns information as well as data from internal inspections and investigations into non-conformances at each stage of manufacturing/assembly/distribution etc. This information can then be used to develop corrective action plans and make necessary changes in order to improve product quality.
  • Regulators: Regulatory inspectors use CAPA software to monitor production processes and investigate non-conformances across industries that they regulate. This allows them to assess the effectiveness of corrective action plans developed by manufacturers/suppliers, identify any issues with compliance regulations, and take appropriate enforcement actions as needed.

How Much Does CAPA Software Cost?

The cost of CAPA software varies depending on the features and capabilities required for an organization's specific requirements. Generally, the amount of money spent on CAPA software can range from a few hundred dollars to tens of thousands of dollars.

At its most basic level, CAPA software typically includes modules to automate inspection and testing processes, provide process workflows and data analysis, facilitate document control and tracking, issue corrective actions or non-conformance notices (NCNs), manage audits and investigations, report incidents or accidents, and track progress against predetermined goals. Other advanced features may also be included such as remote access via mobile devices, integrated incident tracking systems with email notifications to ensure compliance with both internal standards as well as external regulatory requirements.

When evaluating the cost of CAPA software solutions it is important to consider not only the initial license fee but also any additional costs associated with implementation, customization, maintenance and support services that may be necessary in order to maximize value for the organization over time. Depending on the size of an organization’s operations it may be more cost effective to purchase a package that offers several modules in one comprehensive solution rather than adding multiple individual applications piecemeal which can become costly quite quickly.

Ultimately when deciding how much money should be invested in CAPA software organizations must remember that although there is an initial investment involved; implementing this type of technology could yield substantial long-term returns through improved quality assurance processes and increased safety for employees throughout the supply chain.

Types of Software that CAPA Software Integrates With

CAPA software can integrate with a variety of different types of software. This includes Complaint Management Systems, Quality Management Systems, Document Control Software, and Project Management Software. Complaint Management Systems provide tools that help with the tracking and management of customer complaints. Quality Management Software helps support the organization's quality initiatives by allowing users to review products and processes across multiple locations. Document Control Software helps manage the company documents including tracking changes, providing version control, and authorizing access to documents. Lastly, Project Management Software allows you to manage tasks, resources, timelines, budgets and other aspects of project-based workflows. These are just some examples of the type of software that can be integrated with CAPA software to streamline workflow processes as well as improve compliance with regulations.