RadiantPro™
Cleaning Validation
Effective decision making through linking the application to LIMS, QMS, DMS, etc
Flexible installation as requested by the vendor.
Complete 21 CFR Part 11 compliant software with electonic
data management.
Overview
- A single interface for all data related to pharmaceutical cleaning
process.
- Automates residue limit calculation.
- Automates the process of generating cleaning validation protocols and reports.
- Provides a real time paperless tool to capture cleaning activities, sample collection and line clearance.
- Effective decision making through linking the application to LIMS, QMS, DMS, etc.
- Flexible installation as requested by the vendor.
- Complete 21 CFR Part 11 compliant software with electonic data management.
Reduced Risk - Increased Compliance
- A validated calculation engine with fixed formulae ensures the right
value every time.
- Application alerts users to omissions and exceptions.
- Qualification Status of each equipment and product is tracked.
- Method Suitability & Audit Readiness – Single window for all CV data.
Better
Visibility - Improved Productivity
- Justifiable Worst Case Product Identification leading to reduced
validation workload.
- generated Cleaning validation protocol & report saves considerable
time.
- Multiple siloed information brought into a single application
allowing for better decision making.
- Impact Analysis for new product introduction or process chang
More
than a Real Time Paperless Tool
- Cleaning Log ensures that each equipment has been cleaned as per
specified SOP.
- Sample Collection Log ensures that each sampling location is
accounted for and helps track the sample.
- Tracked Line Clearance ensures release of the right areas and
equipment.
- An application that understands real-world cleaning validation and
provides practical solutions requirement.