The pharmaceutical industry prioritizes precision, efficiency, and strict quality standards in its highly regulated environment. This includes validating all computer systems used in drug manufacturing and adopting manufacturing system automation for optimization and competitiveness. CSV and equipment validation in the industry focus on evaluating core systems, managing quality and documents, and validating pharmaceutical drugs. Equipment and instruments like freezers, refrigerators, clean rooms, LIMS, and incubators require periodic testing and accurate record-keeping. Failure in FDA audits or inspections can result in fines, loss of prestige, or even plant closure.
Challenges and Problems in CSV and Equipment Validation include: Time consuming Resource intensive Complicated Expensive Each implementation partner has their own style Work often needs to be redone Unorganized documentation leads to loss of information Information is in silos Turnover in implementation staff
EzVal is an easy-to-use SAAS solution with ready-made templates for validating computer systems. It offers management dashboards with scorecards to effectively monitor and act upon CSV study findings.
EzVal is a cost-effective and time-efficient solution that utilizes AI-based advanced analytics. It provides curated templates for user requirements and features an easy-to-use interface. Additionally, it promotes a paperless approach to streamline the validation process.
Here we can see the story of why EzVal is important and don't just take it from me. Here is the COO of Theragent about how important products like this are to the field.
Looking at us vs the market we can see that
EzVal is a SAAS-based solution that offers customizable template-driven User Requirement Specifications for key components in a CSV audit, including ERP, Quality Management System, Computer Networks and Configuration, and Document Management Systems. It saves time by providing automated manufacturing systems and a checklist template to align URS with implemented and tested software and hardware. The workflow captures and documents equipment tests, importing metadata and test results into EzVal for advanced analytics. It also integrates with Kaye Validators and provides a templated CSV report for CSV auditors to fill in.
This is our expected timeline over the next 8 months as we begin to roll the product out and provide services for it.
SAAS-based solutions provide efficient and comprehensive management of the CSV audit process for pharmaceutical companies, regulatory compliance consulting firms, biologicals, and medical device manufacturers through customizable templates, workflow automation, equipment validator integration, and advanced analytics capabilities. The Pharmaceutical Cleaning Validation Market was valued at US$16.27 billion in 2021 and is projected to grow at a CAGR of 5.7% from 2021 to 2029. Additionally, the global computer system validation (CSV) market was valued at US$3.39 billion in 2012.
