Medical Device Qualified Supplier Directory
Verse Solutions Company Profile
Qualifications: ISO 13485, ISO 9001, FDA Registered, Exhibitor in at least 2 MD&M and/or MEDTEC shows
Markets Supplied: North America
Verse Solutions was developed to help companies comply with regulations to GMP, ISO and FDA standards and initiatives, creating unparalleled visibility and control over critical GMP compliance practices.
Verse Solutions is powered by EtQ, the leading provider of compliance platform technologies for quality, compliance and EHS&S management. With 25 years of experience, EtQ’s platform has connected more organizations to compliance through integration, automation and collaboration.
GMP Compliance Software
In the Life Science industry, regulatory compliance is a critical driving factor towards automation of business systems. The FDA has placed significant oversight on adherence to specific requirements around compliance with Good Manufacturing Practices (GMP), 21 CFR Part 820 and Part 11, among others. This oversight has led companies to strive for transparency in
their compliance processes. With the increased complexity of business, the need for GMP Compliance Software is growing.
Verse Solutions has the tools and the functionality you need to make sure you comply with regulations and stay on top of reporting and recording adverse events.
Verse’s Life Science solutions provides:
Integrated GMP Compliance Audit & Software Solution
You need to ensure your business needs are met. To do this you need software that has been created with your industry’s specific needs in mind. Solutions like Complaints Handling, Corrective Action and Risk Management will ensure the best compliance process possible.
Build a Flexible Workflow
Configurable tools allow users to adapt to unique business processes. With flexible modules and drag and drop features, workgroups are able to remain flexible and productive.
Maintain Compliance Standards
Equipped with automated reporting and recording tools that allow users to stay alert and able to meet regulatory standards event at the most pressing times.
Gain Visibility and Control
Improves quality with a comprehensive reporting engine that allows users to effortlessly manage reports, create alerts and build out detailed charts and graphs. Automated tools centralize dashboards to gain visibility and foster improvement.
Stay Safe and Secure
A personal piece of cloud for quality. Never lose your data, and access your information from anywhere in the world, any time. Making your solution safe, reliable and recoverable.
Electronic Signature Binding
Verse Solutions ensures that the user has signed onto the system and exposed their signature via the forced authentication process, as required by 21 CFR Part 11.
Verse Solutions securely and automatically posts any and all field changes to a separate database. The Audit Trail includes the field’s old value, new value, name of the user who made the change, and date and time.
Regulatory Compliance and Validation
Comprehensive validation documentation is an integral part of the Verse solution, and we provide you with extensive documentation and the scripts necessary to validate your Verse solution.
Cloud Based Document Management System
Verse’s cloud-based document management system lets you create document records, assign keywords to records, attach files of any size/type, and create any number of workflows to route the document through the review and approval phases of the workflow. It also features a comprehensive change request workflow, to ensure that changes to documents follow proper change procedures.
Corrective Action (CAPA) Software
The heart of any GMP Compliance management system, Corrective Action, is a critical component to resolving adverse events. Verse Corrective and Preventive Action software (CAPA) features the ability to run multiple types of workflows, each with its own unique process. Conduct investigations, root cause analysis, correct systemic events, and verify actions are truly corrective to the process. Verse also features built-in risk management tools to apply risk levels to corrective and preventive actions; you can prioritize them by their risk.
Audit Management Software
Verse Audit Management software allows you to create audit plans, with multiple audits throughout the year. You can set up profiles for each audit, with integrated checklists and question data based on keywords from your audit. Questions, checklists and scoring methods are all configurable within the system, and you can generate a comprehensive audit report for all audits within the system.
Complaint Handling Software
Verse Complaint Handling software manages the investigation and resolution of customer complaints while ensuring compliance with FDA and GMP guidelines. It records all complaints reported by customers to initiate an investigation, and keeps a record of customer and product data.
Risk Assessment Software
With Verse Risk Assessment, visibility is expanded across your entire enterprise, giving you the ability to identify trends in risk and take the initiative to mitigate the risk of recurring adverse events. You can create risk templates and configure the risk parameters. Then you can incorporate these risk tools to any process within your system.
For more information contact Verse Solutions