iRISKTM

The Next Generation Risk Management Platform

iRISKTM

iRISKTM is a risk-management platform to identify, quantify and prioritize risks and to formulate risk mitigation strategies over lifecycle (control strategy) for new or existing processes. It is built to ensure that your risk activities drive your Business Processes and are aligned with FDA, EMA GMP-Annex 15 and ICH guidelines.

Winner

Risk Management Award
2017 Most promising solution provider
 

The Next Generation Risk Management Platform


UNIQUE PLATFORM

All necessary tools integrated in one platform for Risk Management throughout lifecycle.

Available languages

iRISKTM supports multiple languages.





Leave your spreadsheets behind

It’s time to leave the spreadsheets behind. We provide a seamless transition to migrate your SOPs and Templates into our solution.

Connect to 3rd party systems

Our expertise dealing with most data sources enables us to provide various 3rd party software integrations.

Ready for global companies

iRISKTM is a collaborative platform that works across different production sites, business units and user-levels. It is a Knowledge Management enabler by allowing users to use a search-engine and benchmark their Risk Analysis activities with other users.

Go beyond Risk Assessments

With iRISKTM proprietary features compare different production lines, equipment and scenarios for optimal risk-based decisions.



GET READY FOR THE REGULATORY LANDSCAPE

With the increased demands for risk-based decisions, companies need corporate solutions supporting Quality Risk Management approaches throu ghout the lifecycle of their products. iRISKTM enables just that by applying the best principles and tools to ensure that your risk activities are aligned with FDA, GMP-Annex 15, EMA and ICH guidelines.

iRISK


COLLABORATIVE

Responsive and logical layout for multi-user collaboration.

VISUALIZATION

Use rich visuals to analyze and compare risks for improved decition-making.

INTEGRATABLE

Data/Information aggregation from different sources.

COMPLIANCE

Built in compliance with FDA, EMA, ICH and GAMP5.



Features

  • Disciplined QRM workflow with a structured KM approach
  • All key tools interconnected in one platform
  • Templates for most situations over process/product lifecycle
  • Consistent Risk-Analysis across the organization
  • Tools for Prior-Knowledge Harvest & Criticality Assessment
  • Brainstorming environment
  • Risk mapping on top of process layouts
  • Documentation management
  • Revised risk profiles over lifecycle
  • Formulation of risk mitigation strategies

iRISK

"Having all tools connected is extremely valuable for us, as well as the ability to monitor risks for different products and prioritize actions."

Director, Large Biopharma (USA)

iRISKTM by the numbers

Numbers tell almost everything. Through our iRISKTM implementations, we gathered several direct business results and day-to-day related improvements.

 

%

LESS TIME SPENT PERFORMING RISK ASSESSMENT

%

LESS EFFORT AGGREGATING INFORMATION

x

REDUCTION OF INCONSISTENCIES AND MISTAKES RATE

%

FASTER RISK ASSESSMENT MEETINGS

%

FASTER TIME TO FILING

%

POST-APPROVAL CHANGES



White Papers

We also compiled some of our customer's experience with iRISKTM in a series of White Papers available on request.

iRISKTM supporting scale-up and process improvement for a biologic product.
iRISKTM transforming risk assessment from a daunting task into a Business Driver


Transition to iRISK

We know how much effort it takes to move years and years of risk assessments and other relevant QRM information into a new platform and that this is a major issue when evaluating such a transition. That's why we can do that for you by moving all of it for you and establish all links between iRISK and other platforms you already use that can complement it. In that way, you can start using iRISK as your new QRM platform where you left off.

Customizable

By customizing the functionality of your iRISK platform, your organization鈥檚 unique requirements can be addressed to enhance your team's performance.

Data Migration

Loading your historical data, SOPs, templates into iRISK so that you only have the benefits of adopting a new tool.

3rd Party Integrations

Our expertise dealing with most data sources and the strategy followed to develop iRISK enables us to link it to various 3rd party software.

Data Integrity

Integrity of your data is an essential quality attribute in the manufacture of pharmaceutical products.

TRANSITION SERVICES

We can migrate your data from most widely used commercial databases or flat files (Excel, Word, Powerpoint, Visio, etc.). Product specialists are available to answer your questions and help you with transition services.

REQUEST TRANSITION SERVICES

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