Audience
Manufacturing companies in search of a solution to ensure quick business decisions, regulatory compliance, and high product quality
About Assure-IQ
For life sciences manufacturers, it is quality or nothing. A streamlined quality process that ensures quick business decisions, regulatory compliance, and the highest product quality requires a robust system. Assure-IQ is designed to deliver. When combined with Caliber’s Document Management and Training and Learning Management systems, organizations can enjoy an unmatched quality experience with Assure-IQ. Assure-IQ is designed to streamline the complete quality assurance system. With 30+ modules to pick from, build a platform that suits you. Along with quality processes, document management and training management can be seamlessly integrated to manage the complete product lifecycle. The on-cloud and on-premise solutions are built on the latest technology to match the changing needs of the industry. A flexible QMS that blends into your company’s systems can help you set your own benchmark for quality success.
Integrations
Company Information
Caliber Technologies
Founded: 2001
India
caliberuniversal.com/solutions/quality-management-system/
Videos and Screen Captures
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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Qualtrax
Qualtrax is a complete quality and compliance software system used to manage and control documentation, automate key business processes with customizable workflows, streamline training management, manage internal and external audits and ensure critical industry regulations are addressed in real-time. Qualtrax is an invaluable resource in heavily-regulated industries, where complying with standards including ISO 17025, 17020, 13485, and 9001, TNI, GFSI, FDA, and FQS is required.
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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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Intellect
Intellect QMS is the latest version of Intellect's flagship product designed to help organizations and quality leaders meet FDA, ISO, and other global GxP regulatory compliance requirements. Intellect offers faster implementation time, robust out-of-the-box QMS capabilities, and extreme configurability to modify or build new apps.
Empower your onsite and remote workforce with virtual auditing, online approvals, 21 CFR Part 11 electronic signatures, and ensure your team can access only approved and up-to-date quality documents, data, reports and analytics anytime, on any device.
Intellect’s Environmental, health, safety and quality (EHSQ) software acts as a data management system for capturing, storing, and analyzing information related to occupational health and safety, waste management, and sustainability. It aims at reducing operational risk and improving health while attaining sustainability goals.
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Product Details
Platforms Supported
SaaS
Training
Documentation
Live Online
In Person
Videos
Support
Phone Support
Online
Assure-IQ Frequently Asked Questions
Assure-IQ Product Features
Quality Management
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Document Control
Equipment Management
Maintenance Management
Risk Management
Training Management
Defect Tracking
ISO Standards Management
Supplier Quality Control