Optiqs360 Digital

Get visibility across disparate systems, connect workers and automate report generation

Optiqs360 Digital is a SaaS digital thread platform that gives users the power to view of all product data, including R&D, Post Market, Regulatory, Supply Chain, Manufacturing, and more.

Through one lens—without logging into multiple other systems—users can see the whole picture – digital threads -about the products they are designing, investigating, remediating, or working on in any way.

Integrates data from multiple enterprise systems

Designed to integrate data from multiple enterprise systems, creating a "Digital Thread" across the organization. Capable of integrating both internal and external content.

Broad in scale and scope

Broader in scope, encompassing quality, regulatory, and operational data across the organization. As a modern SaaS solution it is designed for scope.

Data visualization and automation

Offers more advanced data visualization with dashboards, trends, and alerts like a product batch flow across the value chain from raw materials to customer complaints. Automates reporting and analytics, and facilitates creation of deliverable compliance and business artifacts such as APR’s.

Data analysis and information retrieval

Provides advanced analytics, AI-driven insights, and the ability to "apply intelligence to existing records." Emphasizes rapid information retrieval, as evidenced by the dramatic time savings in the case study

Optics360 includes four main components

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WorkCenter™

WorkCenter is the ‘know and do’

Explore all enterprise data within a single application
Enable a Digital Thread
Apply intelligence to existing records
Create connections and relationships across people and systems
Monitor dashboards, trends, and alerts
Facilitate workflows and business process cycles

automation

IntelliWriter™

IntelliWriter is the automation

Automate reporting and analytics
Facilitate creation of deliverable compliance and business artifacts
Leverage bi-directional integrations with enterprise datasets
Collaborate across silos seamlessly
Enable a single source of truth across technical documentation content

analytics

IntelliStreamer™

IntelliStreamer is the leverage

Publish intelligent data back to the organization
Support enterprise analytics projects with an aggregated and transformed dataset from Optiqs360
Gain new insights and apply AI for organizational objectives

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Professional Services

Help support and sustain

Implementation development services
Business SME and Consulting services
System Support services
Training services for system users and administrators
Facilitation for a customer Center of Excellence (COE)

Some main use cases for Optics360

Annual Product Reviews (APRs)

Yearly required evaluations to assess the quality, efficacy and safety of drugs being reviewed by data (batch quality, deviations, complaints, recalls, stability testing, etc.) gathered throughout the year.

Medical Device Reports (MDRs)

One of the post market surveillance reporting requirements for medical device manufacturers mandated by the FDA/EU when they receive whenever they receive complaints or become aware of adverse events, malfunctions or other issues.

Supply Chain Optimization

The 5-whys root cause analysis workflow requires batch records, raw material COAs, process data, deviation reports, OOS investigation files, supplier audit reports, etc.

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