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.

CAPA

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.

Initiate CAPA

Open a CAPA investigation with source tracking, including product non-conformance, complaints, or more. Assign individuals, set dates, send notifications and follow up.

Check Effectiveness

Easily create visual effectiveness reports with trend analysis and completion rates. Re-open CAPAs if unsatisfactory. Securely extract data in a variety of formats.

SUPPORT Collaboration

Sync your CAPA activities across modules to feed continuous improvement. Link CAPA actions to specific suppliers, other modules, and more.

Document Management

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.

Sort Documents

Classify documents so you can easily find what you need from any location. Categorize internal documents, external documents, and quality system records.

Control Changes

Monitor real-time progress. Automatically send reminders at each step, and alert editors, reviewers and approvers, who can electronically suggest, reject or approve changes.

Manage Access

Limit access to documents to specific employees or work groups and withdraw access at any time. 

Collaborate

Work on documents collaboratively and link them to other modules to prevent duplicate and obsolete documents.

Human Resources

Accomplish quality objectives for employees who directly affect the quality of your products and services.

Manage Employees

Maintain a database of all current and past employees. Establish job profiles, organizational work groups, and departments to easily automate tasks.

Measure Satisfaction

Generate surveys and feedback forms to measure employee satisfaction. Build a productive and collaborative workplace by knowing what your employees think.

Dynamically Manage Competencies

Connect job roles, skills and employees so you know who is qualified to perform a job task. Use real-time competence evaluations to identify gaps.

Automate Training and Certifications

Quickly submit training requests to employees based on customized training plans and curriculum. Track training attendance and generate visual reports.

Customer Management

Easily track customer engagement and ISO 9001:2015 compliance with real-time data and feedback.

Manage Customers

Simplify workflows with a complete database of your customers, including customer code, contact information, location, and field of activity.

Handle Complaints

Respond to customer complaints in real-time to feed the CAPA module, internal audits, and more with information like customer code and severity.

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.

Audit Management

Handle audits quickly and meticulously by preparing your staff and your quality system with the right approach prior to audits.

Schedule Audits

Schedule and automate internal and external audits and notify parties. 

Automate Reports

Record findings and extract visual reports or audit data in other formats.

Improve in Real-Time

Automatically trigger a CAPA or non-compliance based on findings to drive continuous improvement.

Non-Conforming Products

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 reports

Generate visual reports with information like date of detection, description, product code, and severity. Securely export data in a variety of formats.

Remediate Issues

Set a course of action and monitor remediation progress in real-time to validate the decision. Assign tasks and automate alerts and reminders.

Share information

Easily link a non-conformity to an existing CAPA or trigger a new CAPA. Link the non-conformity to a specific supplier if required.

Supplier Management

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.

Manage Audits

Maintain real-time supplier approvals with audit scheduling, reminders, and record keeping. Automatically schedule follow up tasks based on results.

Evaluate Suppliers

Maintain an ASL based on real-time data and customized supplier evaluations. Rank suppliers on past complaints and evaluations, product non-conformities, and quality certifications.

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.

DEFINE KPIs

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 Reports

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.

Metrology

Keep your equipment downtime, complaints, and product non-compliance to a minimum by automating equipment tasks.

Track Equipment

Easily track equipment by description, serial number, supplier, third-party calibration providers and more. Trace applicable testing procedures to equipment.

Evaluate Equipment

Generate visual reports to evaluate equipment based on calibration results, variability in measurement, and performance tests. Securely extract data in a variety of formats.

Manage Schedules

Organize and monitor equipment maintenance, validation, calibration and intervention schedule in real-time.

Intuitively Use Data

Integrate equipment results with other processes like non-conformities or CAPAs.

Meetings

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.

Plan Meetings

Invite and notify participants of a meeting from a workgroup or select individual participants.

Record Minutes

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.

Get A Free Demo

We’ll get back to you within 48 business hours so you can see QualiPro USA for yourself.