BPAMedical365

BPAMedical365 is a validation ready eQMS built on Microsoft 365, designed to help medical device, life sciences and organizations in highly regulated markets manage quality and compliance with confidence. Supporting standards such as ISO 13485, FDA 21 CFR Part 11, GXP, EU Annex 11 and more, BPAMedical365 covers key processes including document control, audits, non conformities, CAPA, risk management, and training, all embedded within familiar tools like SharePoint and Teams.

Our "Validation Toolkit", curated by our expert validation partners, provides a complete set of pre-defined, regulator-ready validation deliverables allowing you to deploy faster, seamlessly respond to audits and significantly reduce the total cost of validation.

Engaging by design, it drives adoption through native Microsoft 365 integration. Secure by architecture, it ensures full ownership and control of your data within your own Microsoft tenant. Used by hundreds of organizations from 5 to 5000 users in all industry sectors, BPAMedical365 is innovative at its core as it leverages AI and robust automation to support decision making, and strengthen compliance.

BPAMedical365 is free of charge for a 30-day trial period and a SaaS subscription is needed beyond this period, please contact sales@bpa-solutions.net for pricing.

With 20+ years of expertise in Quality Management + Microsoft technologies, our quality specialists designed an end-to-end eQMS software that includes the following modules:

- Document control (document management system DMS)

- Stakeholder and supplier management

- Process management including visual process maps

- Regulations and requirement management

- Non-conformance and CAPA action management

- Audit management

- Product lifecycle management

- Change management

- Objective and KPI management

- Risk and hazard management

- Collaborator competencies and training management

- Equipment management

- Information security management

The app package includes SPFx Web Parts and Application Customizers needed for the eQMS to work including:

- Preconfigured e-signatures

- Relational capabilities

- Intelligent forms

- Reminders

- Graphical charts

- Automated document generation

- Microsoft Planner integration

Prerequisites: For installing BPAMedical365 you must have admin permissions over the SharePoint tenant.

The automated first load process will install the needed eQMS pages, forms, lists and columns. After installation completion, BPAMedical365 is ready-for-use and comes with all main features already installed. End users can start working with the app right away.

On request, additional tools and services can be purchased separately to extend BPAMedical365 capabilities, please contact sales@bpa-solutions.net for pricing.

- Prebuilt Microsoft Power Automate workflow sets for document control, non-conformances, CAPA, etc.

- Prebuilt Microsoft Power Apps for easy audit execution, incident reporting, document access, and equipment verification

- Productivity app for Microsoft Teams to interact with the eQMS while discussing

- Forms app for Microsoft Teams to add data in the eQMS while discussing

- BPA Pilot app to search for similarities and use generative AI

- Prebuilt Microsoft Power BI reports

- Software validation services

Access our support page to find the needed documents and videos to start your BPAMedical365 project.

Note: The solution has to be added manually to the site as it will not deploy to the complete tenant.