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
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

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
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

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
Free Trial

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
Free Trial

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 4.6 / 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 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.
  • It is user-friendly software, flexible, and can be integrated if you are a Jira user. It is especially intended for small companies that need a QMS. Things that I like and use daily: tasks, document approval, sending doc for review, creating new forms (managing forms), team chat for meetings, and daily conversations.

Cons

  • 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.
  • What I don't like is that it is aimed at small companies because I feel that this kind of software would be very useful for companies that have 100+ employees. They should develop in that direction.

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

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

Company Information

qmsWrapper
Canada
www.qmswrapper.com

Alternatives

SBS Quality Management Software

SBS Quality Management Software

Sunday Business Systems

Alternatives

Q-Med Database

Q-Med Database

Sunday Business Systems
SBS Quality Database

SBS Quality Database

Sunday Business Systems
Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences

Categories

Categories

CAPA Features

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management

Quality Management Features

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

CAPA Features

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management

Quality Management Features

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Integrations

Jira

Integrations

Jira
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