a Dynamic, Intelligent EQMS
QualiPro USA shares real-time information across eleven feature-rich modules to help make FDA compliance easier. Every module works across all your devices, for any number of users or locations. Pay for just the modules you need, or use them all together. Whatever your needs, we’ll be there with expert support, every step of the way.
Did you know that majority of companies receive an FDA 483 or a warning letter for a CAPA non-compliance? Simplify your CAPA documents and records by automating actions and notifications for individuals and workgroups.
Open a CAPA investigation with source tracking, including product
Sync your CAPA activities across modules to feed continuous improvement. Link CAPA actions to specific suppliers, other modules, and more.
Take the confusion out of documentation. Efficiently edit, store, share, and manage all your documents in one place, without the risks of losing paper documents.
Classify documents so you can easily find what you need from any location. Categorize internal documents, external documents, and quality system records.
Limit access to documents to specific employees or work groups and withdraw access at any time.
Work on documents collaboratively and link them to other modules to prevent duplicate and obsolete documents.
Accomplish quality objectives for employees who directly affect the quality of your products and services.
Maintain a database of all current and past employees. Establish job profiles, organizational work groups, and departments to easily automate tasks.
Dynamically Manage Competencies
Automate Training and Certifications
Quickly submit training requests to employees based on customized training plans and curriculum. Track training attendance and generate visual reports.
Easily track customer engagement and ISO 9001:2015 compliance with real-time data and feedback.
Simplify workflows with a complete database of your customers, including customer code, contact information, location, and field of activity.
Measure Customer Satisfaction
Create satisfaction surveys and send them to customers with a single click. Use responses to inform other modules. Securely export data in a variety of formats.
Handle audits quickly and meticulously by preparing your staff and your quality system with the right approach prior to audits.
Schedule and automate internal and external audits and notify parties.
Improve in Real-Time
Automatically trigger a CAPA or non-compliance based on findings to drive continuous improvement.
Avoid recalls and financial loss by handling non-conformance easily and economically. Ensure future compliance by linking documentation and activities across all modules.
Easily Track Products
Maintain a database of products with details like product code, version, release date, product range, and more, to easily automate tasks and generate reports.
Generate visual reports with information like date of detection, description, product code, and severity. Securely export data in a variety of formats.
Set a course of action and monitor remediation progress in real-time to validate the decision. Assign tasks and automate alerts and reminders.
Easily link a non-conformity to an existing CAPA or trigger a new CAPA. Link the non-conformity to a specific supplier if required.
Streamline supplier workflow, reduce risk, and ensure transparency in your supply chain.
Easily Track suppliers
Track and manage suppliers by code, name, category, activity areas, contact information, and more, for simplified workflows and intelligent reports.
Maintain real-time supplier approvals with audit scheduling, reminders, and record keeping. Automatically schedule follow up tasks based on results.
Maintain an ASL based on
Harness Dynamic Data
Seamlessly integrate supplier processes with other modules. Link supplier complaints and corrective action requests to product non-conformities, customer complaints, and CAPAs.
Key Performance Indicators (KPIs)
Don’t just set goals. Measure progress towards quality objectives, so you can easily track progress.
Set key performance indicators based on objectives, such as data collection frequency, target value, critical limit, responsible personnel, and more to easily measure progress.
Generate visual reports to use as objective measurement during management reviews, and internal and external audits. Or, securely extract data in a variety of formats.
Keep your equipment downtime, complaints, and product
Easily track equipment by description, serial number, supplier,
Generate visual reports to evaluate equipment based on calibration results, variability in measurement, and performance tests. Securely extract data in a variety of formats.
Intuitively Use Data
Integrate equipment results with other processes like
Schedule meetings within QualiPro USA, so you can follow up on the decisions made in the meetings in real-time and ensure smooth implementation of your QMS.
Invite and notify participants of a meeting from a workgroup or select individual participants.
Generate minutes automatically and set future agendas. Follow up on the effectiveness of past meeting decisions.
Link Meetings to Actions
Link a meeting decision to a CAPA action item or an existing CAPA. Modify and update quality objectives based on their achievement status.
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