Ratings and Reviews 0 Ratings
Ratings and Reviews 0 Ratings
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What is Quanticate?
Quanticate offers a broad range of pharmacovigilance services, which encompass the creation and management of safety databases tailored for this field. These databases serve as the main repository for individual case safety reports collected globally regarding a company's pharmaceutical offerings. It is essential to keep these databases up to date with the latest regulatory requirements and to ensure they meet international standards as well as business needs. Quanticate emphasizes the importance of selecting the right database by considering factors such as implementation and maintenance costs, the types of hosting options available (including internal setups, third-party hosting, or cloud solutions from vendors), prior experiences, and compatibility with current systems. They caution that many commercial databases may claim compliance with standards like ISO ICSR ICH-E2B, but true adherence requires careful configuration, thorough validation, and consistent management. Moreover, continuous support and timely updates are vital for preserving the efficiency and dependability of these safety databases as they evolve. Therefore, the choice of database can significantly influence the overall success of pharmacovigilance efforts.
What is Dakota Auditor?
Dakota Auditor provides user-friendly functionality along with a series of checklist inquiries that empower organizations to manage local EHS compliance effectively while also aligning with global auditing and inspection standards. This innovative tool facilitates the assessment of EHS compliance and safety conditions for each location, making the evaluation process more efficient. By leveraging Decision-Tree-Logic, Dakota Auditor helps users identify applicable regulatory requirements and the associated audit checklists that need to be followed. Furthermore, it allows for the integration of customized questions to adhere to internal standards, as well as the application of tags to define more specific audit parameters. Organizations can benefit from utilizing site-specific profiles to assess compliance with pertinent laws and the criteria set by management systems. The auditor's well-structured regulatory database acts as an invaluable Knowledge Base that supports teams regardless of their expertise in Environment, Health, and Safety, thereby ensuring comprehensive evaluations. From the Audit Gauge to the Red Flag dashboards, Dakota Auditor empowers EHS leaders and decision-makers with critical insights, which significantly improve safety and compliance strategies within the organization. This all-encompassing tool not only optimizes the auditing process but also cultivates a culture of ongoing improvement across all locations, reinforcing the commitment to safety at every level. By doing so, it helps instill confidence in stakeholders regarding the organization's EHS initiatives.
Integrations Supported
Additional information not provided
Integrations Supported
Additional information not provided
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
Quanticate
Date Founded
1994
Company Location
United Kingdom
Company Website
www.quanticate.com/pharmacovigilance-safety-database
Company Facts
Organization Name
Dakota Software
Date Founded
1988
Company Location
United States
Company Website
www.dakotasoft.com/proactivity-suite/auditor
Categories and Features
Categories and Features
Audit
Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Exceptions Management
Forms Management
Issue Management
Mobile Access
Multi-Year Planning
Risk Assessment
Workflow Management