Best CAPA Software
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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.
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1
HSI Donesafe
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. -
2
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. -
3
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 -
4
TenForce
TenForce
Track, analyze and report on your EHSQ processes from a single platform. Automate workflows, centralize data and simplifiy collaboration across departments. TenForce offers various integrated modules to help streamline processes such as Audits, Incident Management, CAPA, 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 -
5
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 -
6
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 OrdersStarting Price: $45/user/month -
7
Artintech ERP
Artintech
Artintech ERP is a comprehensive enterprise resource planning solution designed to optimize and streamline your business operations across various departments. Tailored for small to medium-sized enterprises (SMEs), Artintech ERP offers robust functionality with a user-friendly interface, allowing businesses to seamlessly manage their resources, inventory, human capital, finances, and customer relations all in one integrated platform. Artintech ERP includes a wide range of modules designed to optimize business operations. Key modules include Procurement, Warehousing, CRM, Distribution, Quality Management (QMS), Workplace Safety, Document Control, Non-Conformance and Corrective and Preventive Actions (CAPA), Inspection, and Computerized Maintenance Management System (CMMS).Starting Price: $24.95/Module/Month -
8
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.Starting Price: $250/month/10users -
9
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.Starting Price: $12.49 per user/month -
10
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: $199 per month -
11
Qualityze EQMS Suite
Qualityze
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.Starting Price: $30/User/Month -
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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
Galactica
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
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 NotificationsStarting Price: $500 one-time payment -
15
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 -
16
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.comStarting Price: $2,300/year -
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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 -
18
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-ShopStarting Price: $10,000 / Annually -
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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 -
20
SBS Quality Management Software Suite
Sunday Business Systems
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 -
21
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 -
22
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. -
23
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. -
24
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 -
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MyBlueLabel
MyBlueLabel
Now you have the option of your own Quality Management Expert in the shape of an online platform. Templates ready to be integrated in your company to enable smooth processes. We offer complete Quality Management Systems and online solutions for ISO 13485 Medical Devices and ISO 9001 General Quality Management.Starting Price: $235 per month -
26
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 -
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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
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28
Falcony
Falcony
Reveal the unreported and uninspected. Get unprecedented involvement and visibility to build safer, happier, and more productive workplaces with your employees. The frontline employees and managers now expect frictionless mobile-first experiences from reporting, workflows, and communication. Most reporting systems fail to involve and are used only by a small fraction of people. This all leads to insufficient or skewed situational awareness with unwelcome surprises. It’s not the management teams, but all your people in the field who are aware of the pressing issues and all the tiny observations that impact your business and operations. What they are waiting for is to have a voice, to be involved, to solve problems, and to have an impact. Having different reporting tools for individual functions increases the threshold of use for end-users. Falcony empowers your employees and stakeholders with a perfect companion to reveal everything they observe, inspect, collaborate and resolve.Starting Price: €150 per month -
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FieldKo
FieldKo
Powered by GPT AI and Salesforce, we make it easy for your team to conduct inspections, identify risks, assign corrective action requests, prioritize tasks and manage checklists, everywhere you work. Meet the app helping businesses inspect and connect from anywhere. Mobile, connected and secure. We provide teams with real-time insights they can trust to mitigate risk and resolve high-priority actions effectively. Make inspections easy for everyone. Configure questions, tasks, and workflows to create comprehensive Customer 360 views so your inspectors get the job done right the first time, every time. Enable stakeholders to act effectively. Leverage workflows, corrective action plans, and time of inspection flagging features to ensure issues are resolved accurately and efficiently. Use prebuilt digital checklists to streamline data sharing across workflows, creating a secure and scalable data-gathering structure for your business.Starting Price: Free -
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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