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What is Enzyme QMS?

Our Quality Management System (QMS) features extensive modules that address every stage of the product life cycle, from Design Control to Corrective and Preventive Actions (CAPA). We provide your entire team with training and stand ready to support you whenever you need assistance. Enzyme Consulting, LLC. focuses on customizing and executing your Quality System to align with your unique requirements. After you finish the onboarding process, our team remains available for ongoing conversations and to answer any questions you might have. Established by experienced industry experts who were dissatisfied with existing QMS solutions, Enzyme's system is specifically crafted for life science companies, emphasizing the distinct challenges associated with developing FDA-regulated software. With the backing of our dedicated consultants, you can confidently bring your product to market. Our consultants not only have direct experience in the medical device industry but also excel in accurately assessing risks, which enables them to deeply understand the challenges encountered during product development. This comprehensive support ensures that you are not navigating these complexities on your own, allowing for a more seamless journey to successful product launch. Furthermore, our commitment to your success means we are continuously evolving our services to better meet your needs.

What is BPAQuality365?

BPAQuality365 is a quality management system (QMS) software that operates within the secure environment of Microsoft 365 cloud. It utilizes familiar tools that your team already engages with daily, eliminating the need for any alterations to user habits. This modern software is versatile, functioning seamlessly across all devices while being tailored to meet your specific requirements, and it harnesses the latest M365 technologies. The application boasts robust features for managing compliance documents, conducting audits, tracking non-conformances, implementing CAPA actions, and handling processes, process maps, incidents, changes, risks, FMEA, SWOT analyses, equipment, and health, safety, and environmental modules in adherence to ISO 9001, FDA Part 11, and medical regulations. Furthermore, the QMS application integrates smoothly with Teams, allowing users to inquire about the QMS during discussions and easily share QMS cards with colleagues. You can elevate your endeavors toward Quality 4.0 by leveraging advanced AI capabilities alongside superior workflow automation and insightful business intelligence. BPA's status as a Microsoft Preferred partner enables you to tailor your QMS according to your unique demands, collaborate effectively with power users, and deepen your understanding of M365 technologies, ultimately enhancing your organization's overall efficiency and compliance.

Media

Media

Integrations Supported

GitHub
Jenkins
Jira
Microsoft 365

Integrations Supported

GitHub
Jenkins
Jira
Microsoft 365

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Enzyme

Date Founded

2016

Company Location

United States

Company Website

www.enzyme.com

Company Facts

Organization Name

BPA Solutions

Date Founded

2001

Company Location

US/Switzerland

Company Website

www.bpa-solutions.net/software/office365-quality-app/

Categories and Features

Quality Management

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

Categories and Features

CAPA

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

Compliance

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

Quality Management

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

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