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

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.

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

Audience

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

Audience

Companies in the Life Science industries - Medical Device, Pharmaceutical, Biotechnology, Laboratory, and others.

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported

API

Offers API Not Supported

API

Offers API 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

$13,750/year
Everything is included, with no additional costs for implementation, modules, support, hosting, validation, etc.
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 1.0 / 5
ease 1.0 / 5
features 1.0 / 5
design 1.0 / 5
support 2.0 / 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

  • The technical staff were the best part of our experience. During onboarding they made a real effort to explain how the system works and to help whenever we had questions, and they were responsive and patient throughout. The platform is built on Microsoft Azure and Microsoft 365, so documents live in a familiar SharePoint/Office environment rather than in a completely proprietary system.

Cons

  • In our experience the system is extremely inconvenient, cumbersome and inflexible. Everyday document work requires far more clicks and steps than it should, the interface is heavy, and adapting the workflows to how our company actually operates proved impractical. After evaluating it we decided not to implement it at all. The far bigger problem is the commercial side. Read the termination and renewal provisions extremely carefully before signing. Based on our experience you cannot simply stop using the service during the contract year and stop paying. Notice must be given at least 90 days before the renewal date; miss that deadline and you may be invoiced for another full contractual period even though you no longer use the system. Termination must be submitted in writing and its receipt expressly confirmed. We told the company twice by telephone that we wanted to discontinue the service, and those conversations were not treated as formal notice. Do not rely on phone calls: send written notice, request written confirmation, and keep all correspondence.

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

SimplerQMS
Founded: 2017
Denmark
www.simplerqms.com

Alternatives

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Sunday Business Systems

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QualityPro by TecWork

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Dot Compliance QMS

Dot Compliance QMS

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QT9 QMS

QT9 QMS

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Categories

CAPA Supported
Quality Management Supported

Categories

Audit Supported
CAPA Supported
Compliance Supported
Document Control Supported
ISO Compliance Supported
Quality Management Supported

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 Supported
Nonconformance Tracking Supported
Quality Control Supported
Risk Management Supported
Root Cause Analysis Not 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 Supported
ISO Standards Management Supported
Maintenance Management Supported
Risk Management Supported
Supplier Quality Control Supported
Training Management Supported

Audit Features

Alerts / Notifications Supported
Audit Planning Supported
Compliance Management Supported
Dashboard Supported
Exceptions Management Not Supported
Forms Management Supported
Issue Management Supported
Mobile Access Supported
Multi-Year Planning Not Supported
Risk Assessment Supported
Workflow Management Supported

Compliance Features

Archiving & Retention Supported
Artificial Intelligence (AI) Not Supported
Audit Management Supported
Compliance Tracking Not Supported
Controls Testing Not Supported
Environmental Compliance Not Supported
FDA Compliance Supported
HIPAA Compliance Supported
Incident Management Not Supported
ISO Compliance Supported
OSHA Compliance Not Supported
Risk Management Supported
Sarbanes-Oxley Compliance Not Supported
Surveys & Feedback Not Supported
Version Control Supported
Workflow / Process Automation Supported

Document Control Features

Archiving & Retention Supported
Automated Routing Supported
Change Management Supported
Compliance Management Supported
Electronic Signature Supported
Escalation Management Supported
Periodic Review Supported
Version Control Supported

Integrations

Microsoft 365 Not Supported
Microsoft Entra ID Not Supported

Integrations

Microsoft 365 Supported
Microsoft Entra ID Supported
Claim CAPA Manager and update features and information
Claim CAPA Manager and update features and information
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