CAPA Manager

CAPA Manager

Adaptive Business Management Systems
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About

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.

About

qmsWrapper is a connected Quality Management System (eQMS) built specifically for medical device startups and SMEs. Instead of implementing a complex enterprise platform from day one, organizations can grow their QMS through three connected editions: Foundation, Lifecycle, and Vigilance. Foundation helps companies move from paper forms, Word documents, and spreadsheets to controlled documents, workflows, training, and AI-assisted quality processes. Lifecycle adds CAPA, Quality Events, Change Control, Risk Management, Technical File management, Supplier Quality, and Smart Traceability Matrix. Vigilance extends the platform with post-market surveillance, regulatory oversight, audit readiness, and AI governance. Built for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper helps companies scale their quality system without rebuilding or migrating to another platform.

Platforms Supported

Windows Supported
Mac Supported
Linux Supported
Cloud Supported
On-Premises Not Supported
iPhone Supported
iPad Supported
Android Supported
Chromebook Supported

Platforms Supported

Windows Supported
Mac Supported
Linux Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Audience

Organizations that want to optimize Improvement and Corrective Action management to gain the competitive edge and achieve compliance.

Audience

Medical Device Companies, MedTech Startups, SaMD, eQMS, ISO 13485, ISO 14971, FDA QMSR, EU MDR, Quality Management, Regulatory Affairs, Quality Assurance, CAPA, Risk Management, Technical File, Traceability

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported

Support

Phone Support Not Supported
24/7 Live Support Not Supported
Online Supported

API

Offers API Not Supported

API

Offers API Not Supported

Screenshots and Videos

Screenshots and Videos

Pricing

$12.49 per user/month
Flexible price plans to suit your organization. Use for free with a two-user limit!
Add as many users as you like, activate as needed up to your limit.
Monthly or annual billing options are available.
Free Version Supported
Free Trial Supported

Pricing

€3,499
Foundation starts at €3,499 per year with unlimited users. Lifecycle and Vigilance pricing is available on request. All editions are designed to grow with your quality management needs without requiring migration to a new platform.
Free Version Not Supported
Free Trial Supported

Reviews/Ratings

Overall 5.0 / 5
ease 5.0 / 5
features 5.0 / 5
design 5.0 / 5
support 5.0 / 5

Reviews/Ratings

Overall 4.7 / 5
ease 4.5 / 5
features 4.6 / 5
design 4.1 / 5
support 4.8 / 5

Pros & Cons from Real Users

Pros

  • We’ve been using this CAPA management software for over a year now, and it’s been super helpful. The CAPA tools make it easy to log, track, and close actions. It's especially useful for CAPA in pharmaceutical industry settings, where everything needs to be documented and audit-ready.
  • The software is mostly user-friendly, but some of the more advanced features do take a bit of time to get the hang of. Also, if you’re a smaller business, the price might feel a little high, especially as you add more features or users.
  • The software is user-friendly and straightforward, allowing us to quickly log, track, and manage security incidents. It ensures that all issues are addressed promptly, helping us avoid any potential compliance gaps. The automated notifications and reporting features are particularly helpful, keeping the team informed and focused on resolving problems as they arise. Overall, the system helps us maintain a high level of organization, which is critical for our security protocols.
  • The software is easy to use and does a great job of tracking any issues we need to fix. It works well with our other systems, helping us keep accurate records for compliance. The automatic reminders and reports are super useful, especially when preparing for audits or inspections.
  • I found this software user-friendly and effective at streamlining corrective actions, helping me maintain compliance with aerospace regulations and standards. Its tracking features enhance my ability to monitor nonconformities and improve overall quality management.

Cons

  • The interface could use a refresh, and the reporting side has room for improvement. It works well overall, but small tweaks would make it even better.
  • While the software has great potential, it feels overpriced for what you get, especially for smaller businesses. Some features that should be more straightforward can be confusing, and the learning curve for advanced functions could be frustrating.
  • While the software meets most of our needs, it could benefit from more advanced customization options. Some of the more complex features require additional setup, but once configured, they work effectively.
  • Some of the advanced features needed a bit of extra training, but once we got used to them, they really improved our workflow.
  • The initial configuration process was more complex than I anticipated, requiring dedicated IT resources for setup.

Pros & Cons from Real Users

Pros

  • I like having documents, training, CAPAs, risks and other QMS activities in one place. It saves a lot of time compared with working across different files and tools, and it is much easier to see how things are connected. I also like that the system is flexible and we can adjust processes when needed.
  • I love the interface and the helpful dashboard that reminds you daily of tasks related to you. The Quality Manual is editable and free to use, making it very user-friendly. Custom templates, notifications, automation, and risk management features are ideal for small and medium-sized companies. The technical support is excellent, answering all our questions quickly and accurately. If we need additional explanation, they are happy to schedule video training for us. Additionally, it's great for managing all kinds of projects, not just those related to quality. Documentation management, including approvals, revision history, and organization in folders, is straightforward. The Traceability Matrix is the best I've seen and very easy to use. The new Risk Module is very helpful with its added questions.
  • Robust process engine automates workflows, minimizing errors and improving efficiency. Responsive development team actively listens to user feedback and implements requested features.
  • Managing with qmsWrapper is easy, I am using it to organize my department. The team works easily and everything is recorded in detail in the system.
  • qmsWrapper is an exceptional QMS software that has transformed our quality management processes. The software is intuitive and the modules are meticulously designed. The traceability matrix capability provides valuable insights into the relationships between requirements, tests, and other project elements, enhancing overall quality and compliance.

Cons

  • There is a bit of a learning curve at the beginning because there are a lot of features. Some areas could also be a little more intuitive, but once you get used to the system, everyday work becomes quite straightforward.
  • Sometimes you need to refresh the page for updates to show
  • Primarily designed for small and medium-sized companies, limiting functionality for larger enterprises.
  • Sometimes slow, but regardless, I can work without interruption.
  • While qmsWrapper offers impressive features, some users may experience slight slowness in the software's performance. However, this minor issue does not significantly impact its overall functionality or hinder the effectiveness of the quality management processes.

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Supported

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Not Supported

Company Information

Adaptive Business Management Systems
Founded: 2009
United Kingdom
www.adaptivebms.com/CAPA-Software/

Company Information

qmsWrapper
Canada
www.qmswrapper.com

Alternatives

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SBS Quality Management Software

Sunday Business Systems

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SBS Quality Database

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Dot Compliance QMS

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Categories

CAPA Supported
Quality Management Supported

Categories

CAPA Features

Audit Management Supported
CAPA Planning Supported
Change Management Not Supported
Complaint Management Supported
Incident Management Supported
Nonconformance Tracking Supported
Quality Control Supported
Risk Management Not Supported
Root Cause Analysis Supported
Training Management Not Supported

Quality Management Features

Audit Management Supported
Complaint Management Supported
Compliance Management Supported
Corrective and Preventive Actions (CAPA) Supported
Defect Tracking Supported
Document Control Supported
Equipment Management Supported
ISO Standards Management Not Supported
Maintenance Management Not Supported
Risk Management Not Supported
Supplier Quality Control Supported
Training Management Not Supported

CAPA Features

Audit Management Supported
CAPA Planning Supported
Change Management Supported
Complaint Management Supported
Incident Management Not Supported
Nonconformance Tracking Supported
Quality Control Supported
Risk Management Supported
Root Cause Analysis Supported
Training Management Supported

Quality Management Features

Audit Management Supported
Complaint Management Supported
Compliance Management Supported
Corrective and Preventive Actions (CAPA) Supported
Defect Tracking Supported
Document Control Supported
Equipment Management Not Supported
ISO Standards Management Supported
Maintenance Management Not Supported
Risk Management Supported
Supplier Quality Control Supported
Training Management Supported

Integrations

Jira Not Supported

Integrations

Jira Supported
Claim CAPA Manager and update features and information
Claim CAPA Manager and update features and information
Claim qmsWrapper and update features and information
Claim qmsWrapper and update features and information