Audience
Companies seeking a solution to verify ongoing compliance against relevant regulatory requirements
About Dakota Auditor
With out-of-the-box applicability and checklist questions, Dakota Auditor helps organizations address local EHS compliance while synchronizing global audit and inspection programs. The auditor makes it easy to test each site's EHS compliance and safety status. Using Decision-Tree-Logic, Auditor guides users in identifying applicable regulatory requirements and audit checklists. Users can add custom questions to address internal policies and use tags to further refine audits. Leverage site-specific profiles to assess compliance with applicable regulations and conformance with management system requirements. Auditor’s structured regulatory database provides a consistent Knowledge Base for your teams, regardless of their Environment, Health, and Safety experience, helping to ensure quality reviews. From the Audit Gauge to Red Flag dashboards, Auditor provides EHS leaders and decision-makers with the insights they need.
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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Chemical Safety Software
Chemical Safety offers a comprehensive suite of environmental health and safety software applications. Features include GHS Labeling, Safety Data Sheets, Chemical Inventory Tracking, Hazardous Waste Management, Environmental Regulatory Reporting, and Employee Workplace Safety & Compliance. Everything you need to track your chemical inventory and hazardous waste from beginning to end. EMS addresses all of the special issues associated with storing, using, and disposing of hazardous materials. Safety Data Sheets: Manage and Distribute SDS's Online. A cloud-based safety data sheet management solution. Easy online access for all employees. Monitor and manage all aspects of employee and workplace safety including safe storage and use of chemicals, alerts and notifications, employee training requirements and site incident tracking with corrective actions.
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Qualityze EQMS Suite
Qualityze is a leading provider of enterprise quality management solutions, utilizing the Salesforce.com Technology Platform to build our EQMS Software solutions. Our team is 100% devoted to quality processes, compliance, and regulatory guidelines to address our customers' business environments. We do not distract ourselves with custom work or quality concerns.
The idea of helping our customers create a culture of quality is not a new concept, but the way we developed our application, Quality Management Software, based on making it easy to use, intuitive, and inclusive. Therefore, the entire organization is involved in quality, not because they are told they should, but because it's easy, fun, and has a logical flow.
We strive to optimize quality with excellence through our exclusive range of smarter quality management software solutions.
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Pricing
Free Trial:
Free Trial available.
Integrations
No integrations listed.
Company Information
Dakota Software
Founded: 1988
United States
www.dakotasoft.com/proactivity-suite/auditor
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Product Details
Platforms Supported
SaaS
Training
Documentation
Webinars
Live Online
In Person
Support
Online
Phone Support
Dakota Auditor Frequently Asked Questions
Dakota Auditor Product Features
Audit
Compliance Management
Dashboard
Exceptions Management
Multi-Year Planning
Risk Assessment
Workflow Management
Alerts / Notifications
Audit Planning
Forms Management
Issue Management
Mobile Access