GxP Evo Pro ™ is currently under development - Launching in 2021
CV Evo Pro ™ aims to streamline and standardise the calculations required for cleaning validation execution due to the ever-increasing regulatory impact that is faced by the pharmaceutical & life sciences industry.
One example market is the customs productions sites that require a streamlined switch over from one product to another to meet increasing production demands from the global market
1. Quicker formulation of custom scenarios concerning cleaning validation between various new / old production products / processes
2. Streamlined cleaning validation limit determination for current and future process / production runs to ease burden on cleaning verification and validation runs
3. Streamlined test bed for the determination of impact of potential product runs to help in the planning of production schedules
4. Streamlined method / system for use in the determination of potential impact due to regulatory changes that may be introduced
4. Process workflow management from end to end including calculation and documentation templates
5. System is validated and Annex 11 / Part 11 Compliant. Local and remote installation options are available
DI Evo Pro ™ aims to streamline and standardise the assessment, mitigation and corrective action for Annex 11 / Part 11 due to the ever-increasing regulatory impact that is faced by the pharmaceutical & life sciences sectors.
1. Automated interface & database for input of assessment data to determined compliance status as per Annex 11 / Part 11
2. Templates and FMEA RPN approach applied within interface for automated compliance determination.
3. End to end workflow management system for individual and intregrated system assessment, mitigation and correction with documentation templates
4. Test bed platform for adjustment of parameters for assessment as per on site and corporate requirements
5. System is validated and Annex 11 / Part 11 Compliant. Local and remote installation options are available
MP Evo Pro ™ aims to streamline and standardise the calculations required for KPI / KQI recording, analysis and reporting. Fully customisable with automated visual and tabular data analysis for full QMS monitoring as per ISO 9001 / 13485.
1. Automated data import tools from manual sources and software suite via intergration plugins
2. QMS Reporting Tool: Automated QMS and Quality Management Review reports via dashboard with customisable PDF / Word report generation for submission via your document management system
3. Dedicated KPI / KQI Dashboard: Dashboard with drill down and analysis capability to drive monitoring, contionious improvement along with identification of repeatability issues within your Quality & Operations Management Systems
4. Fully customisable metric definition input for automation, dashboard creation for different departments and organisational structures
5. System is validated and Annex 11 / Part 11 Compliant. Local and remote installation options are available
CV Evo Pro Licence ™ Only