Audience
Organizations and enterprises in need of a quality management solution to help manage their compliance
About Sercle QMS
Delivering Quality Management Software to help manage your compliance against ISO standards. Such as ISO 9001, ISO 13485, ISO 17025, FDA, GMP, BRC. EQMS software is being placed into many different companies within different industries and with different ISO requirements with an overarching goal of helping in achieving product quality and optimum standards. Some EQMS applications are better suited as enterprise quality management systems and other systems for small to medium-sized businesses however regardless of setting, below are some key points that components of any of the best quality management software out there. Businesses may implement a quality process like CAPA (Corrective Action Preventative Action) into their EQMS software and this process may look different from one business to another even if they belong to the same sector. The ability to customize the workflow, fields, layouts to adapt to the behaviour of the business ensures a smooth implementation.
BPAQuality365
BPAQuality365 is a prebuilt QMS software to use in your secured Microsoft 365 cloud, leveraging tools used by collaborators daily, with no need to change user habits. It’s modern, compliant with any device, flexible to match your unique needs, and powered by innovative M365 technologies. The app includes powerful compliance document management, audit, non-conformance, CAPA action, risk, equipment, health, safety, environment modules compliant with ISO 9001, FDA Part 11 and medical regulations. The QMS app is closely integrated to discussion flows in Teams and enable instant quality improvement. Go a step further and reach your Quality 4.0 objectives by combining powerful AI features, best-in-class workflow automation, business intelligence and mobile Power Apps to run on any device. Benefit from BPA’s Microsoft Preferred status to configure your QMS to your needs, transfer knowledge to your power users and get trained on M365 technologies.
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SimplerQMS
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.
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Dot Compliance QMS
Dot Compliance provides the industry’s first off-the-shelf QMS solution – ready to deploy from day one, with little to no setup required, while also incorporating industry best practices and standards that address the latest global regulatory requirements.
Powered by the Salesforce.com platform, our solutions enable life science organizations to quickly digitize their quality and compliance processes including Document Management, Training Management, Change Control, CAPA, Customer Complaints. Compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14971, 27001 & MORE!
Processes included:
▶ Document Management
▶ Training Management
▶ Quality Event Management
▶ CAPA Management
▶ Change Management
▶ Complaint Management
▶ Audit Management
▶ Supplier Quality Management
▶ Risk Management
▶ Design Control
▶ Deviations/Non-conformances
✔ Seamless Install
✔ Cost Effective
✔ One-Stop-Shop
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Total Lean Management (TLM) Software
Perfect for a small company, TLM has everything you need, and can accelerate the implementation with consulting, training, procedure templates, and document writing/coaching support, plus we have validation templates and a system setting mode so small medical device companies have special features to help manage technical files and 510K submittals.
TLM QMS Software saves you money AND makes your QMS more effective by providing a dual technology landscape for the two distinct QMS user types.
Core modules include:
• Audits
• Contact Manager (CRM)
• CAPA
• Customer Feedback
• Document Management
• Electronic Forms
• Employees
• Employee Feedback
• Equipment Calibration
• Evaluations
• FMEA
• Inspections
• Inventory/parts
• Library
• Meetings/Reviews
• Metrics
• Projects
• Purchase Orders
• Quality Record Mgt
• Rejected Materials
• Risk & Opportunities
• Sales Orders
• Strategic Planning
• Surveys
• Tasks/Events
• Training
• Work Orders
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Integrations
No integrations listed.
Company Information
Sercle
United States
www.serclesoftware.com/quality-management-software/
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This means every device on your network, and every interface on every device is automatically analyzed for performance, errors, QoS, and configuration.
Product Details
Platforms Supported
SaaS
Training
Documentation
Live Online
In Person
Videos
Support
Phone Support
24/7 Live Support
Online
Sercle QMS Product Features
Quality Management
Audit Management
Complaint Management
Corrective and Preventive Actions (CAPA)
Document Control
Equipment Management
Training Management
Compliance Management
Defect Tracking
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control