FAQ

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Questions fréquemment posées

Product and technology overview

What are BPAQuality365 and BPAMedical365?

BPAQuality365 and BPAMedical365 are two powerful, Microsoft 365-based eQMS (electronic Quality Management System) platforms from BPA Solutions, designed to suit different regulatory and operational needs, but both with a strong focus on usability, automation, and compliance. Intuitive and agile, they run directly on Microsoft 365 (SharePoint, Teams, Power BI, etc.) and support secure deployment, including in highly secure environments (such as GCC High) to meet strict data-control requirements. Learn more about why you should choose Microsoft 365 for your QMS >

Covering everything from document control, audits, non-conformances, risk and training management, they are designed to help companies comply with common quality and risk standards (like ISO, FDA, GDPR, EU MDR) while helping users navigate quality tasks more efficiently.

Which Microsoft technologies does the QMS rely on?

BPAQuality365 and BPAMedical365 are built in your familiar Microsoft 365 environment, leveraging Teams, SharePoint, Power Apps, Power BI (and more), and help teams collaborate without changing their work and daily habits.

What are the differences between BPAQuality365 and BPAMedical365?

BPAMédical365 is specifically built for regulated life sciences, medical devices, pharma and healthcare industries. The platform is fully compliant with GxP guidelines, ISO 13485, EU MDR, FDA 21 CFR Part 11, offering features like electronic signatures, access control, and complete audit trails. Coming with a Validation Toolkit (SOPs, test scripts, validation templates) to accelerate regulatory validation and reduce validation cost, BPAMedical365 is a pre-validated eQMS solution. Learn more about the Validation Toolkit >

Is the BPA eQMS available in multiple languages?

Yes. Our eQMS is natively available in English, German, and French, ensuring seamless adoption across international teams. Additional languages can be added as part of an extended configuration, making the platform fully adaptable to global quality, compliance, and regulatory environments.

Modules and features

Which quality modules do you support? Are they based on pre-built workflows?

BPAQuality365 and BPAMedical365 include 20+ ready-to-use quality modules designed to cover the full spectrum of document, process, risk, and improvement management needs. Our prebuilt modules span document control, stakeholder & supplier management, process and improvement management (CAPA, NC, audits), competencies & training, asset & equipment management, and comprehensive risk management. All modules come out-of-the-box with robust automation, allowing you to deploy your eQMS quickly and reach an efficient go-live with minimal setup. Discover all our modules >

Can I configure or customize modules?

Each module can be configured and adjusted to match your specific quality processes, regulatory needs, and internal workflows, without heavy customization or development. No-code configurations can be quickly done ensuring an optimal fit for your specific organization’s needs (workflows, forms, pages, views, etc.)

Is there AI / GenAI in BPA QMS software?

BPA’s QMS comes with powerful, safe, and productivity-boosting GenAI built for quality and compliance. BPAQuality365 and BPAMedical365 include built-in GenAI capabilities through Q-Pilot, BPA’s secure, enterprise-grade virtual assistant. Q-Pilot allows users to instantly find the right procedures, records, risks, or training information simply by asking natural questions, dramatically reducing time spent searching or navigating the QMS. It also assists quality managers with everyday tasks such as summarizing content, guiding workflows, and improving overall productivity. Learn how Q-Pilot can assist you >

AI features in BPA’s eQMS are secure-by-design: all data stays within your Microsoft 365 tenant, no information is shared externally, and the architecture follows BPA’s strict privacy, governance, and security standards. This ensures that organizations can benefit from GenAI innovation without compromising data protection or regulatory compliance. How does BPA stay secure by design? >

Security, data and compliance

Où sont stockées les données et qui les contrôle ?

Your data is securely stored in your own Microsoft 365 environment, directly on SharePoint and fully controlled, governed, and monitored by you. Because BPAQuality365 and BPAMedical365 run natively within your Microsoft tenant, no data is transferred, hosted, or duplicated on external systems. BPA Solutions never accesses or stores your information.

This “your environment, your data” approach ensures security, compliance, and data-sovereignty. Combined with BPA’s secure-by-design architecture, your quality data stays protected, private, and fully compliant while benefiting from the power of Microsoft 365. Learn more about BPA’s “your environment – your data” approach >

What security measures are in place?

BPAQuality365 and BPAMedical365 rely on the enterprise-grade security of your Microsoft 365 environment, ensuring your eQMS meets the highest standards for data protection and regulatory compliance. All security measures are built-in, secure-by-design, and governed entirely by your tenant. Key protections include:

  • Data encryption at rest and in transit using Microsoft 365’s advanced security framework.
  • Multi-Factor Authentication (MFA) and conditional access policies to prevent unauthorized access.
  • Granular permission and role-based access control, ensuring users only see what they are authorized to see.
  • Complete audit trails, secure electronic signatures, and validation-ready controls for regulated industries.
  • Secure-by-design AI features, ensuring no data leaves your Microsoft tenant and all AI interactions remain private and compliant.

This architecture delivers a highly secure, compliant, and region-aligned eQMS, ideal for organizations with strict quality, regulatory, or data-sovereignty requirements.

Do you support high-security environments (e.g. GCC High)?

Yes. BPAQuality365 and BPAMedical365 fully support high-security Microsoft cloud environments, including GCC High. Because our eQMS is installed directly inside your own secure Microsoft 365 tenant, you benefit from your existing government-grade security, compliance, and data-residency controls, without relying on external hosting.

Our GCC High–ready architecture ensures that regulated organizations, government contractors, and defense-related industries can run a modern, Microsoft-based eQMS while meeting strict security and regulatory requirements. Learn why BPA is a GCC High Cloud-ready eQMS solution >

Is BPAMedical a validation ready QMS software?

Yes, BPAMedical365 is a validation-ready QMS software. It comes with a comprehensive validation toolkit, including SOPs, test scripts, and templates, to help you efficiently validate your system in compliance with GxP, ISO 13485, FDA 21 CFR Part 11, and EU MDR requirements.

This approach accelerates regulatory compliance while giving your team full flexibility to configure the eQMS according to your specific medical, pharmaceutical, or healthcare processes. Learn more about the validation toolkit >

Implementation and onboarding

What is your project methodology (phased, agile, configuration)? How long does implementation take?

BPA follows an agile methodology for implementing our solutions. Because we have prebuilt app packages and workflows, the implementation is usually very quick and effective (3-5 days max). A dedicated senior consultant for your account will accompany you through this journey and will follow up closely the development of the project scope, priorities, timeline and knowledge transfer. En savoir plus >

Can I pilot modules first?

Yes, you can absolutely start by piloting just a few BPA modules. Many organizations begin with a small, controlled rollout (for example, 2–3 modules in a single department or site) to validate how the solution fits their processes, industry requirements, and internal organization. After experiencing the value in a focused scope, customers typically expand to additional modules and scale the eQMS across sites, entities, or the entire company.

We also offer flexible pricing plans based on company size, making it easy to start small and grow at your own pace. This approach ensures a low-risk, high-impact introduction to digital quality management while giving your team hands-on experience before scaling. Learn more about our pricing plans >

Do I need to migrate my SharePoint / on-prem assets?

No. You do not need to migrate your existing SharePoint assets to use BPAQuality365 or BPAMedical365. Our eQMS is deployed directly inside your existing Microsoft 365 environment, meaning your data, documents, and security stay exactly where they are, fully controlled by your organization.

If you choose to modernize into Microsoft 365, BPA Solutions can support you with optional migration, integration, and configuration services. Many customers simply activate BPA modules within their current cloud tenant and go live quickly with minimal disruption. This “your environment, your data” approach ensures the smoothest onboarding, preserves your existing IT investments, and maintains full compliance, governance, and data residency aligned with your region.

Pourquoi migrer vers SharePoint Online dans le nuage ?

Migrating from on-premises SharePoint to SharePoint Online gives your organization stronger security, lower costs, and instant access to Microsoft’s latest innovations. Microsoft 365 is trusted by 1+ million companies worldwide, offering industry-leading security, compliance, and governance—far beyond what most organizations can maintain on their own infrastructure. By moving to the cloud, companies typically achieve a 300%+ ROI through reduced server costs, minimized maintenance, and fewer internal resource demands.

BPAQuality365 and BPAMedical365 are built to run natively on Microsoft 365 and SharePoint Online, ensuring your eQMS is always up to date with the newest security features, modern workflows, integrations, and AI technologies. Migrating to the cloud not only future-proofs your quality system but also unlocks the full potential of BPA’s modern, automation-driven eQMS. Learn why Microsoft365 is the ideal environment for your eQMS >

Un environnement Azure est-il nécessaire ?

No, you do not need your own Azure environment to use BPAQuality365 or BPAMedical365. An Azure environment is already included in your BPA subscription and fully managed by BPA, ensuring optimal performance, secure-by-design architecture, and seamless integration with Microsoft 365. If your organization prefers, you can also run BPA in your own dedicated Azure environment, giving you full control over infrastructure, governance, and data residency.

This flexible “your environment, your data” approach ensures every organization, regardless of size or IT maturity, benefits from a secure, modern, and scalable cloud foundation for their eQMS.

Integration and automation

Le BPA peut-il s'intégrer à Dynamics 365 ?

Yes, BPA integrates seamlessly with Microsoft Dynamics 365. With our dedicated Dynamics 365 QMS connector, you can connect your SharePoint-powered eQMS with Dynamics 365 Business Central and Finance & Supply Chain Management, enabling end-to-end process visibility across quality, operations, and ERP data.

This integration opens unlimited possibilities: synchronized records, automated workflows, unified master data, and smoother cross-department collaboration. The result is a more connected, efficient, and intelligent quality ecosystem fully aligned with your Microsoft business applications. Learn more about the Dynamics 365 Connector >

Can I link the QMS with other external systems (third party CRM and ERP, as SAP)?

Yes, you can connect BPAQuality365 and BPAMedical365 with external third-party systems, including CRMs and ERPs such as SAP. Because BPA runs natively on SharePoint and Microsoft 365, integrating with BPA is similar to integrating with any SharePoint-based solution. Numerous connectors and integration options are available depending on your business needs.

These integrations are delivered as custom projects, allowing us to tailor data flows, workflows, and automation to your specific processes. Whether you need synchronized master data, automated quality workflows, or deeper supply-chain connectivity, BPA helps you build a seamless, high-performance ecosystem across your QMS and external business applications.

Une application pour téléphone est-elle prévue ?

Yes, BPAQuality365 and BPAMedical365 already work on any device, including phones and tablets, thanks to their native Microsoft 365 and SharePoint architecture. For an optimized mobile experience, we also provide dedicated PowerApps, including:

These apps make it easy for field teams, operators, auditors, and frontline users to work efficiently from anywhere, supporting a fully mobile, modern eQMS experience.

How does GenAI work in the system?

BPA’s GenAI features work securely inside your Microsoft 365 environment, helping users find information faster, simplify tasks, and improve decision-making, without ever exposing your data externally.

Our GenAI engine, Q-Pilot, analyzes the content already stored in your SharePoint-based eQMS and allows you to ask natural questions, generate summaries, retrieve procedures, review risks, or get guidance on quality workflows. All AI processing stays within your tenant, following BPA’s secure-by-design architecture to ensure full privacy, data residency, and regulatory compliance. In short: GenAI works as an intelligent, fully secure assistant that boosts productivity while keeping your quality data 100% under your control. Learn how BPA AI-Driven eQMS stays secure by design >

Licensing, pricing and subscription

What subscription or licensing models do you offer?

We offer flexible subscription plans designed to fit organizations of any size and maturity. Our licensing model is user-based, with tiers adapted for small teams, growing companies, and large or regulated enterprises. Each plan includes BPA’s full Microsoft 365–native eQMS platform, security updates, and access to core modules.

You can start small and scale as your needs evolve, and optional add-ons (such as medical compliance features or industry-specific extensions) can be added at any time. This flexible model ensures you only pay for what you need while maintaining a future-proof, fully scalable quality management system. Discover our plans >

Are there additional fees for external users / suppliers?

In many cases, external users and suppliers can collaborate with your BPA eQMS at no additional cost. Thanks to Microsoft 365 tools like MS Forms, external stakeholders can submit incidents, audits, feedback, or other key data without needing extra Microsoft licenses or BPA user seats.

This approach allows you to extend your quality processes across suppliers, partners, and contractors while keeping licensing costs under control, making BPAQuality365 and BPAMedical365 both scalable and cost-efficient for multi-stakeholder collaboration. Discover how external users can populate your eQMS >

Do you offer discounts for multi-year contracts/volume?

Yes, BPA Solutions offers multi-year contracts, typically up to three years, with potential discounts based on the number of licenses, selected modules, and contract duration.

Special conditions may apply, and our flexible pricing ensures that organizations of any size can optimize cost while scaling their eQMS efficiently. This approach allows you to plan long-term, maximize ROI, and benefit from a fully supported, Microsoft 365–native quality management system. Discover your ROI with BPA >

Quel est le prix par utilisateur/mois et comment est-il facturé ?

The price per user/month for BPAQuality365 and BPAMedical365 depends on the number of licenses purchased. We offer cost-effective plans tailored to your company size and requirements, with a minimum of 7 licenses.

Subscriptions are billed annually, and if canceled on time, access stops at the end of the current period. External stakeholders, such as auditors, suppliers, or other departments—can participate using Microsoft Forms at no additional cost, making it easy to extend your quality processes without extra licensing. Learn more about our flexible plans >

What is included in the subscription fee?

  • Licences d'utilisation nominatives avec des autorisations spécifiques.
  • Dedicated senior consultant for modules and extensions set up and specific configurations.
  • Knowledge transfer and complete training of power users.
  • Mises à jour fréquentes du logiciel pour des caractéristiques, des fonctionnalités et une flexibilité accrues.
  • Data migration management – for turnkey projects our migration partners will assist you.
  • Assistance à la clientèle 24 heures sur 24

L'assurance logicielle est-elle incluse dans l'abonnement annuel ?

Yes, BPA Software Assurance (SA) is included in your annual subscription. This ensures you receive all software updates, security enhancements, and feature improvements automatically, keeping your BPAQuality365 or BPAMedical365 system always up to date, secure, and fully compliant.

La formation est-elle incluse dans l'abonnement ?

Yes, training is included as part of your subscription alongside implementation services. During the implementation phase, BPA transfers knowledge to your power users, ensuring your team can confidently configure, use, and manage BPAQuality365 or BPAMedical365. This hands-on approach helps accelerate adoption, streamline workflows, and maximize the value of your eQMS. En savoir plus sur nos services >

Est-il possible d'effectuer un paiement unique pour l'achat de vos produits ?

No, BPA Solutions products are only available via subscription. We do not offer a one-time purchase option. The subscription model ensures you always have access to the latest features, updates, security enhancements, and support, keeping your BPAQuality365 or BPAMedical365 system modern, compliant, and fully maintained.

Que se passe-t-il si nous mettons fin à notre contrat avec BPA Solutions ?

If you stop your contract with BPA Solutions, all your data remains fully available in your own SharePoint environment. While you will no longer have access to BPAQuality365 or BPAMedical365 features, you retain complete control over your quality data, since none of it is hosted or managed by BPA. This ensures uninterrupted data security, compliance, and accessibility, even after contract termination.

User access and permissions

Des utilisateurs externes peuvent-ils accéder au logiciel BPA ?

Yes. External users can easily access BPA software as guest users. You can securely involve suppliers, auditors, and other stakeholders without adding extra licenses. External parties can also submit data using Microsoft Forms at zero additional cost, making collaboration simple, controlled, and budget-friendly.

This flexible access model helps organizations extend their QMS beyond internal teams while maintaining full security and compliance.

How are permissions and external users (suppliers, auditors) managed?

Permissions in BPA’s eQMS are managed natively through SharePoint, giving you full control over user roles (including reader, contributor, admin, and super admin) directly within your Microsoft 365 environment. This ensures secure, compliant, and scalable access management across all sites and entities.

For external stakeholders such as suppliers or auditors, the easiest and most cost-efficient option is to share Microsoft Forms, allowing them to submit data without requiring licenses. This approach streamlines collaboration while keeping your environment secure and fully under your control. Discover what you can do with the different types of licenses provided by BPA >

Support and maintenance

What support do you provide (helpdesk, SLAs)?

We provide a professional helpdesk, clear SLAs, and a full range of Professional Services to ensure your eQMS runs smoothly from day one. As part of your subscription, our experts support you with:

  • Installation – We deploy the software on your Microsoft 365 tenant and Azure server, ensuring a secure, seamless setup aligned with your environment.
  • Configuration – We adapt BPA to your processes, configuring workflows, modules, and Power BI reports to match your operational and compliance needs.
  • Training – Your team receives hands-on training to become fully autonomous in using, configuring, and evolving the platform.
  • Data migration – Our specialists help you migrate data from shared files or SharePoint sites, ensuring a clean and reliable transition.
  • Coaching & consulting – We work with you to translate your business requirements into a fully automated, efficient, and compliant eQMS.
  • Project management – You’re guided through every step, with clear scope, priorities, and timelines for a smooth and timely implementation.

This comprehensive support model ensures you get maximum value, performance, and long-term success from your BPA eQMS. En savoir plus sur nos services >

Do you offer dedicated support or only shared resources?

Yes, we offer both dedicated and shared support options. During the initial implementation, you benefit from dedicated support to ensure a smooth and successful rollout. As your needs evolve, you can purchase additional Professional Services hours for extra guidance or when expanding with new modules.

You also have access to our shared resources (knowledge base) through the BPA Community site, which includes video tutorials, step-by-step guides, and best-practice documentation; helping your team learn, troubleshoot, and grow independently.

How are updates / bug fixes handled?

BPA delivers continuous, transparent, and reliable software maintenance. You receive monthly updates (CUs) and bi-annual major releases, all announced through our BPA Community portal, where detailed release notes are published. If you encounter an issue, our ticketing system allows you to quickly report bugs and receive timely assistance, fixes, or patches, ensuring your eQMS remains secure, stable, and always up to date.

Training and adoption

Do you provide training (onboarding, user training)?

Yes, we provide complete training as part of our implementation services. Your team receives hands-on onboarding and in-depth user training, ensuring they quickly become self-sufficient in using, configuring, and evolving the software.

Our experts guide you through best practices, workflows, and customization options. This ensures rapid adoption, optimized workflows, and the ability to meet your organization’s evolving quality and compliance needs. Learn more about our training approach >

Is there documentation / learning resources (videos, guides)?

Yes, absolutely. In the BPA Community site you will find a wealth of tutorials, step-by step guides and best-practice documentation, helping your team learn, troubleshoot and grow independently.

Que faut-il pour configurer le logiciel ?

Configuring BPAQuality365 or BPAMedical365 requires collaboration with your Power Users, who receive hands-on knowledge transfer during setup. Our prebuilt workflows and secure Microsoft 365 environment allow your team to quickly get up and running while gaining autonomy over the system.

Because every organization’s processes and industry requirements differ, the platform remains highly configurable. We tailor workflows, forms, and Power BI reports to align with your internal processes, ensuring optimal performance, regulatory compliance, and a QMS that truly fits your business needs.

Performance and updates

How scalable is BPAQuality365?

BPAQuality365 is highly scalable to meet the needs of growing organizations. New users can be added easily, with permissions quickly managed through SharePoint’s native controls.

Additional modules can be activated instantly, as all modules are prebuilt and ready to use without any service disruption, allowing you to expand your eQMS seamlessly across departments, sites, or business units.

What is the frequency of software updates / releases?

Software updates and bug fixes are fully managed by BPA. Clients are informed of monthly cumulative updates (CUs) and major releases, typically twice a year, with release notes published on our community portal. Updates are applied without downtime, ensuring your eQMS remains available and fully functional.

For issues or bugs, a ticketing system allows you to report problems easily and receive timely assistance and patches, keeping your BPAQuality365 or BPAMedical365 system secure, up to date, and reliable.

Quel est le champ d'application des communiqués mensuels ?

Monthly releases for BPAQuality365 and BPAMedical365 include a mix of bug fixes, product improvements, and new feature enhancements.

These updates ensure your eQMS remains secure, up to date, and continuously improving, helping your organization stay aligned with evolving quality management best practices and regulatory requirements.

Que faire si les performances sont lentes ?

Performance of BPAQuality365 and BPAMedical365 primarily depends on your Microsoft 365 data location and internet connectivity. Under normal conditions, users experience fast and reliable performance across all modules, ensuring smooth, efficient quality management operations.

Use cases and deployment scenarios

Which industries do you serve?

BPA serves a wide range of industries that require robust, flexible, and compliant Quality Management Systems. Our solutions are used worldwide in sectors such as medical devices, life sciences, pharmaceuticals, manufacturing, food & beverage, energy, automotive, services, and high-tech.

Because BPAQuality365 and BPAMedical365 are modular, configurable, and fully Microsoft 365–native, they easily adapt to the specific regulatory and operational needs of any industry.

Can you share success stories?
Absolutely, we have multiple success stories across a variety of markets, including medical devices, manufacturing, and life sciences.

You can explore real-world results, implementation strategies, and customer testimonials on our Success Stories page, where we showcase how organizations worldwide have transformed their quality management with BPAQuality365 and BPAMedical365.

Do you offer versions for regulated industries?

Yes. BPA offers dedicated versions for regulated and highly regulated industries. BPAMédical365 is specifically designed for life sciences, medical devices, and other highly regulated sectors, supporting standards such as ISO 13485, FDA 21 CFR Part 11, and EU MDR.

For organizations requiring elevated security, our eQMS is fully compatible with the Microsoft GCC High cloud, meeting stringent government and defense-level requirements.

Can I deploy on-prem vs cloud?

BPA’s eQMS is cloud-based and deployed directly inside your existing Microsoft 365 environment. This means all your data, documents, permissions, and security remain fully under your control; no external hosting, no data migration, and no on-premises installation required.

By leveraging Microsoft 365 and SharePoint Online, you benefit from continuous updates, strong security, and seamless scalability. Learn why Microsoft365 is the ideal environment for your eQMS >

Combien de clients BPA compte-t-elle actuellement ?

BPA serves over 200 clients across 25 countries, ranging from small teams of 7 users to global organizations with more than 5,000 users. Our customers span all sectors, with a strong presence in manufacturing, medical devices, and life sciences, reflecting the flexibility and scalability of our eQMS solutions. Learn more about our customers’ implementations >

Company and trust

Who is BPA Solutions?

BPA Solutions is a global software company that specializes in eQMS (electronic Quality Management System) solutions built on Microsoft 365 and SharePoint Online. Founded with a mission to modernize quality and compliance, we serve over 200 clients across 25 countries. Our team combines deep industry expertise in regulated sectors, such as life sciences, manufacturing, medical devices, with Microsoft technical mastery to deliver secure, scalable, and intuitive quality management platforms.

With over 20 years of development expertise, we are a Microsoft Preferred Partner specializing in modern eQMS solutions built natively on Microsoft 365 and SharePoint. Learn more about our history, values, and global presence on our About Us page.

Where is your headquarters?

Our headquarters is based in Innovation Park of Yverdon-les-Bains, Switzerland. We also operate a U.S. office in Seattle, near Microsoft’s headquarters, highlighting our strong technical alignment with Microsoft technologies and our long-standing expertise as Microsoft specialists.

Do you have partnerships?

Yes, BPA maintains strong partnerships to enhance the value of our eQMS solutions. We have worked closely with Microsoft for over 15 years and hold Microsoft Preferred Partner status, reflecting our deep expertise in Microsoft 365 and SharePoint technologies.

We also collaborate with selected implementation and technology partners worldwide. Organizations interested in partnering can learn more on our Become a Partner page.

Do you offer partner programs?

Yes, BPA offers several partner programs designed for consulting firms, integrators, and technology providers who want to deliver modern, Microsoft-based quality and compliance solutions.

Our programs support partners with training, co-selling, technical enablement, and marketing resources. You can explore all partnership opportunities on our Become a Partner page.

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