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

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.

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

Life science companies

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

$25,000 / 1st year
25k for first year with a 5 license minimum
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 4.5 / 5
ease 4.5 / 5
features 5.0 / 5
design 4.5 / 5
support 4.5 / 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

  • Documents,training and quality all link up together. Has the ability to create custom web forms to meet the specific needs of the company. It enables business process workflow.
  • - The best feature is definitely the fact that this is a web based tool that stores everything in the cloud and has no system dependency.

Cons

  • Such function is good but simple searches can turn up too many unnecessary results.
  • The UI can definitely be further simplified to remove unnecessary buttons that might confuse the uninitiated. Currently, it's also a bit difficult to get help information from the UI.

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

MasterControl
Founded: 1994
United States
www.mastercontrol.com

Alternatives

SBS Quality Management Software

SBS Quality Management Software

Sunday Business Systems

Alternatives

Q-Med Database

Q-Med Database

Sunday Business Systems
Propel

Propel

Propel Software
SBS Quality Database

SBS Quality Database

Sunday Business Systems
CAQ.Net

CAQ.Net

CAQ AG Factory Systems

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

Change Management Features

Approval Workflow
Audit Trail
Automated Notifications
Change Calendar
Change Planning
Compliance Management
Prioritization
Release Management
Task Management
Tracking & Reporting
Training Management

Complaint Management Features

Case Management
Complaint Classification
Corrective Actions (CAPA)
Customer Complaint Tracking
Feedback Management
Forms Management
Issue Tracking
Quality Assurance Management
Routing
Self Service Portal
Social Media Monitoring
Survey Management

Compliance Features

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
Incident Management
ISO Compliance
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Document Control Features

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

Document Management Features

Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Capture
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
Email Management
File Recovery
File Type Conversion
Forms Management
Full Text Search
Offline Access
Optical Character Recognition
Print Management
Version Control

Document Version Control Features

Access Controls/Permissions
Approval Process Control
Archiving & Retention
Audit Trail
Commenting / Notes
Document Check-in / Check-out
For Engineering Documents
Revision History
Version Comparison
Version Rollback

Risk Management Features

Alerts/Notifications
Auditing
Business Process Control
Compliance Management
Corrective Actions (CAPA)
Dashboard
Exceptions Management
Internal Controls Management
IT Risk Management
Legal Risk Management
Mobile Access
Operational Risk Management
Predictive Analytics
Reputation Risk Management
Response Management
Risk Assessment

SPC Features

Corrective Actions (CAPA)
Data Entry
Data Linking
Data Management
Excel Loader
Job Management
OPC Data Collection
Performance Metrics
Point-of-Production Analysis
Real Time Data Collection
Regulatory Compliance

Work Instructions Features

Branding & Style Sheets
Content Management System
Drag and Drop
Dynamic Tags
Employee Feedback
Guide Approval Workflows
Media Editor
Multi-Brand Publishing
Rich Text Editor
SSO (SAML)
Translations
User Management
Version Control

Integrations

Inspired eLearning HR & Compliance
Microsoft Excel
Microsoft PowerPoint
Microsoft Word
Res_Q
SAP Business ByDesign
Showpad Coach
VIPRE Security Awareness

Integrations

Inspired eLearning HR & Compliance
Microsoft Excel
Microsoft PowerPoint
Microsoft Word
Res_Q
SAP Business ByDesign
Showpad Coach
VIPRE Security Awareness
Claim CAPA Manager and update features and information
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