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Lean QbD Features

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QbD Software - for the Smart Scientists

QbD Risk Assessment | Design Space | Knowledge Management

Pharma 4.0 | KASA: Knowledge Assisted Structured Application

How Lean QbD Works

Step 1

Enter Parameters: With Lean QbD™ Templates, you can begin instantly, skipping over much of the tedious initial setup you are used to. Customize QTPP/CQA/CPP input according to your need. We also offer import services to help you migrate from excel, or other data formats.

Step 2

Assign Risk: Our specialized Risk Assessment grids and wizards make it simple, de-coupling scientist time and function. At each step, take notes and store associated metadata and file attachments as needed.

Step 3

Critical Parameters: Comprehensive charting & reporting (including user customized input for (C)PP's and Rationale) make it easy to determine patient risk. Our Exhaustive Risk Assessment Documentation Report helps you to prepare for FDA submission faster than ever.

Discover why leading companies perform

their Risk Assessment using LeanQbD

  • Secure Cloud Solution

Work anywhere, securely, easily

  • Ready-To-Use Templates

Shortcut Risk Assessment faster than ever, removing the painful and tedious entry of parameters

  • Team Collaboration

Collaborate together or apart, on the same or different schedules

  • Dynamic Charts

Visualize your data and critical parameters/processes

  • Snapshot History

Save snapshots of your data to view back at any point in time.

  • Comprehensive Reports

A myriad of different reports for your different needs, including the exhaustive complete Risk Assessment Documentation Report

  • Create Customizable Report Templates

Setup your own created/customized reports (as many as you'd like) to run/re-run instantly for every drug you'd like. Save weeks of tedious documentation write-up

  • Upload Attachments, Notes

Document your thoughts and rationale at each step

  • Import/Export

Export and download your complete Risk Assessment files that you can import later.

  • Simple Input, Comprehensive Output

The LeanQbD Grids and Wizards were designed by a collaboration of QbD and UI/UX experts to simplify Risk Assessment more than ever

  • Automatic, Secure Cloud Backups

Never worry about losing your data, or reverting back to old data. Accidently ruined weeks of work? give us a call

  • On-Premise Installation Available

Does your company have strict requirements about offsite or cloud data? We've got you covered. We can install the LeanQbD system on your own in-house servers.

  • QbD Experts At Your Service

Do you need some QbD Expertise - Our team is here to help you. We also offer QbD services, and are always available for questions and assistance.