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.