BPAMedical365 vs BPAQuality365 – Gap Analysis

BPAMedical365 has been recently released for regulated industries to comply with medical compliance standards like ISO 13485 or part 11 CFR 21. The app was built for any industry looking for a more secure approach when taking decisions, by using eSignatures with multi factor authentication.

Office365-eSignature

From a feature perspective, most modules included in BPAMedical365 are the same like in BPAQuality365. However, some differences exist which are highlighted in the table below.

BPAMedical365BPAQuality365
Prebuilt cloud app for medical compliance.Prebuilt cloud app for quality & compliance.
Ready to be used in your secure Office 365 environment and leveraging all Office 365 technologies.Ready to be used in your secure Office 365 environment and leveraging all Office 365 technologies.
Compatible with any device.Compatible with any device.
Prebuilt modules for managing:

  • Stakeholders
  • Processes
  • Compliance documents
  • Improvement (PDCA)
  • Equipment
  • Information assets
Prebuilt modules for managing:

  • Stakeholders
  • Processes
  • Compliance documents
  • Improvement (PDCA)
  • Equipment
  • Information assets
Prebuilt modules for managing:

  • Hazards
  • Incidents
  • FMEA
Prebuilt modules for managing:

  • Risks/Opportunities
  • Incidents
  • Health/Safety hazards
  • Environmental aspects
Prebuilt modules for managing:

  • Products and product versions
  • Technical files
  • Changes
Prebuilt module for managing:

  • Changes
Prebuilt intelligent forms including preconfigured eSignature fields.Prebuilt intelligent forms (eSignature fields can be configured if needed).
Set of powerful webparts and components to improve user experience, including:

  • Navigation
  • Forms
  • Document and data viewers
  • eSignature component, including preconfigured eSignatures
  • Productivity tools
  • Settings
Set of powerful webparts and components to improve user experience, including:

  • Navigation
  • Forms
  • Document and data viewers
  • eSignature component
  • Productivity tools
  • Settings
Prebuilt Power Automate document management workflow set, preconfigured to include eSignature approvals (available as an option).Prebuilt Power Automate document management workflow, including standard Office 365 approvals (available as an option).
Prebuilt Power Automate workflow sets for the main BPAMedical365 modules, preconfigured to include eSignatures (available as options).Prebuilt Power Automate workflow sets for the main BPAQuality365 modules (available as options).
Prebuilt nonconformity Power Apps (available as an option).Prebuilt nonconformity Power Apps (available as an option).
Prebuilt audit Power Apps (available as an option).Prebuilt audit Power Apps (available as an option).
Prebuilt Power BI reports (available as options).Prebuilt Power BI reports (available as options).

Both apps can be tested on our discovery platform.

Ask us for a free trial.

Shift to Quality 4.0 at Each Stage of the Value Chain

Shift to Quality 4.0 at Each Stage of the Value Chain

At BPA Solutions, we propose an agile end-to-end QMS software aligning people, processes and technology to simplify your quality 4.0 journey by leveraging your existing Microsoft 365 tools.

  • People: we bring simple tools to improve quality, for everyone, on any device.
  • Processes: we shift to instant quality improvement with team workflows and discussions.
  • Technology: we unleash the power of Microsoft 365 technologies with automation, AI and BI.

Quality 4.0 – BPA Value Proposition

In the journey towards implementing Quality 4.0 initiatives, we recommend to start simple by looking at your pain points, check opportunities and make a small scale pilot. Here is our value proposition:

  • Increase the speed and quality of decision making with prebuilt automated workflows and shift to instant quality improvement with discussions, video conferencing, and business intelligence reports.
  • Improve transparency, traceability, and auditability with a simplified access to your end-to-end QMS software by everyone, on any device. Simplify auditing with our prebuilt Audit Power Apps.
  • Evolve relationships and organizational boundaries to reveal opportunities for continuous improvement by including internal and external stakeholders on secured workspaces and workflows.
  • Augment human intelligence with coming AI tools to search for document content by asking natural questions and find similarities.

Make each stakeholder an actor of your continual improvement system, thanks to BPA modern apps.

Ask Us for a Free Modern App Trial Now !

BPA Modern Apps

Moving to Modern Apps from BPA Classic Apps

The new released BPA modern apps for Quality, Medical, CRM and App Builder bring ultimate user experience and performance with Office 365.

The table below shows a high level feature comparison between BPA classic apps and the new modern apps.

High Level FeaturesModernClassic
BPA Quality, CRM and App Builder apps

X

X

BPA Medical App

X

Better user experience and performance (answering time)

X

Use the app on any device (phones, tablets, etc.) thanks to responsive design

X

Better compatibility with O365 technologies (Office, SharePoint, Teams, Power Platform, Forms, Power BI)

X

Use the app in Microsoft Teams

X

BPA Power Extensions (prebuilt power automate workflows, Power Apps, Power BI reports) ready to be used with modern apps

X

Prebuilt Power Automate workflows for document management, nonconformities, audits, changes, actions, etc. ready to be used with modern apps

X

Prebuilt Power Automate eSignature workflows (ready to be used with BPAMedical365)

X

BPA Audit Power Apps, ready to be used with BPA Quality and Medical

X

BPA Incident Power Apps, ready to be used with BPA Quality and Medical

X

Prebuilt Power BI reports, ready to be imported in the client O365 environment

X

Prebuilt modules for environmental aspects, health and safety hazards, assets IT security (included in BPAQuality365)

X

Prebuilt modules for product lifecycle management; products, versions, changes, FMEA, technical files (included in BPAMedical365)

X

BPA Master Detail component (view all items + details and relations in one single page)

X

BPA Modern eSignature component (based on MS multi factor authentication)

X

Full page width mode (display items/documents in full page width)

X

Share to Teams (start a discussion in Teams)

X

BPA Modern Reminder component (create conditional reminder rules, e.g. 1 single notification to assignee for all late actions)

X

Embed graphical Office documents in BPA forms and components

X

Coming AI and ML features (searching document by asking natural questions, search for similarities)

X

BPA Query component* (building multi-list queries)

X

BPA Permissions component* (breaking permissions based on conditions)

X

BPA KPI component* (displaying indicators or risks in a scorecard)

X

Developed on the latest SharePoint Framework and Microsoft development technologies.

X

* scenarios exist to replace these features with modern apps and Office 365 technologies (ask your BPA team).

We propose our clients different migration paths from on premise/cloud classic apps to modern apps.

On premises Classic to Modern Apps

The recommended path is to migrate the whole BPA site to Office 365 Classic and progressively create modern pages with BPA modern components. The benefit is to keep existing configurations in classic mode and progressively introduce modern experience modules with no system interruption. This scenario requires a SharePoint migration tool.

In case few configurations have been done, another path would be to start from the out-of-the-box modern template and migrate existing data module per module. This option would best fit in case changes and improvements need to be done while migrating.

Any existing automated workflow need to be redone with Power Automate. BPA propose prebuilt workflow sets ready to be imported in your tenant and plugged in with our modern apps. This drastically saves implementation time.

Office 365 Classic to Modern Apps

Good news, no data migration is needed in this case. Simply start creating pages with BPA modern components to display existing data and progressively introduce modern modules to end users. Trained power users will be autonomous to do the transition after a short knowledge transfer.

Depending the amount of configurations done with classic, another path would be to start from the new modern templates and import existing data.

Ask Us for a Free Modern App Trial Now !

Intelligent Teams Forms

Intelligent Forms to Run on Any Device with Teams and SharePoint

Intelligent Teams Forms

Designing intelligent forms including eSignatures with the graphical BPA Form Designer.

There are several limitations and constraints when using standard SharePoint forms in the context of quality, compliance or for any other business purpose. A major challenge is to display specific forms and fields to specific users in the different process steps.

BPA has developed intelligent form capabilities, including a modern form interface compliant with any device (like phone or tablets), and a drag-and-drop form editor for non-IT persons (e.g. business persons) to design great data-entry forms with advanced possibilities.

When using our apps for quality, medical compliance and CRM, we have designed prebuilt forms to match typical usages, like document approval, incident handling, risk management, etc.

BPA Forms can be used on your preferred devices and favorite tools, like Microsoft Teams or SharePoint. Frontline users and back office collaborators can register events anywhere with any device.

Using BPA Forms, we provide the best user experience throughout the whole process lifecycle. Conditional forms make sure only the right data can be collected for a specific process step, e.g. registration data at registration step, investigation data at investigation step, etc. eSignatures and automated workflows ensure only authorized signers can validate their workflow steps.

BPA Forms are automatically prefilled with the correct parent data, so we keep relations between related items and enforce users to register coherent data with less effort. When filling in a form, you can easily retrieve data from other lists by typing. Cascading rules make sure users will select consistent values in the form.

BPA Forms can be easily designed by power users and previewed prior sharing with collaborators. The drag and drop editor lets users select tabs, sections and rows to group fields. BPA eSignature fields can also be added in forms.

Start building intelligent forms to match your pressing business needs to be used on any device with Teams and Office 365.

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Office365 MailMerge

Generate Reports on the Fly – Modern Mail Merge Component

Produce documents on the fly

Generate instant reports and documents in a click of a button, including data, signatures and images.

Business persons in the Quality, Compliance, Sales or any department spend a lot of time to prepare reports, like audit reports, nonconformity reports, management review reports, sales proposals, etc.

We just introduced a new modern mail merge component to generate formatted reports in a click of a button, which drastically simplifies time and effort to prepare structured reports.

BPA’s Mail Merge components is very flexible. Simply start from your existing report templates in Word format or start creating new templates. Placeholders can be simply added to merge any data or content you need to display in your report.

Users can produce complex reports by clicking a button, like a nonconformity or audit report. Text data, eSignatures, and photos will be merged in the report, which can be converted to PDF. A graphical wizard guides end users to generate custom reports by following a few steps.

The mail merge component can be used in Power Automate workflows to automatically generate reports when needed. For example, an audit report would be automatically produced when the audit execution has been completed and sent to the concerned persons, with no manual task needed.

The component is available with BPA’s modern apps for Quality, Medical and CRM and seamlessly integrates with Microsoft 365 technologies.

Ask us for a free trial

Office 365 eSignature

Preconfigured eSignature Workflows in BPAMedical365

Medical eSignature workflows

Prebuilt Power Automate workflow for document approval including eSignatures.

BPAMedical365 is a new preconfigured modern software for medical compliance to meet regulations, like ISO 13485. It’s running on any device with Teams and SharePoint in your secure Microsoft 365 environment.

More and more organizations are willing to leverage their existing Office 365 tools to manage quality and compliance. In this context, BPA has developed a ready-for-use software including prebuilt eSignature forms and automated workflows, ready to be installed in your environment.

Power Automate workflows have been designed to include generic business rules to match typical organizations’ needs. BPA’s eSignature component will check only authorized users can sign their specific work. Tools are very flexible to be adapted by functional persons.

Among prebuilt eSignature workflows included in BPAMedical365:

  • Compliance document approval and training
  • Technical file approval
  • Product approval
  • Nonconformities
  • Changes
  • Incidents
  • Audits
  • CAPA

Any paper signature can be easily digitalized with BPA’s intelligent forms, eSignature module, and Power Automate workflows.

Thanks to preconfigured modules to match ISO 13485, prebuilt workflows and eSignature capabilities, BPAMedical365 drastically simplifies your medical compliance journey.

Ask us for a free trial

ASQ Live Demo 2021

Shift to Instant Quality with BPA & Microsoft Teams – ASQ Live Demo 2021

Shift to instant quality with BPA software and Microsoft Teams – ASQ Live Product Demo, May 2021

This live BPA product showcase was presented during the ASQ virtual conference for quality and improvement, on May 27, 2021.

BPA develop innovative software solutions for quality and compliance to run in your secure Office 365 environment, with Microsoft Teams and SharePoint, leveraging the Microsoft Power Platform with Power Automate, Power BI and Power Apps.

During this live demo, you learn how to move to instant quality using our modern QMS software together with Microsoft Teams, in the context of nonconformity and CAPA management.

In this session, we demonstrate how easy anyone can report a nonconformity by taking photos with a mobile device, and instantly alert all members from your improvement team. We go through a typical 8D problem-solving process, using BPA QMS software directly inside Microsoft Teams, together with discussions and video conferencing. We explore Power BI reports to consolidate CAPA actions in a central dashboard and make your weekly improvement meetings productive.

Discover how you can significantly increase your improvement teams reactivity, reduce time to close incidents, and improve efficiency by using our QMS software with Teams, discussion flows and Office 365.

Share To Teams button in BPA Software

Introducing Share To Teams in BPA Software Solutions

Breaking news – You can now start a discussion in Teams in a click of a button from any page in our QMS, Medical and CRM software.

Navigating away from your software to start a discussion in Teams and losing context is not a smooth experience. With the Share To Teams feature, you can launch a discussion from any item or document without leaving the BPA software and context, boosting productivity and enabling instant decisions.

Share To Teams

Share To Teams is a quick and easy way to start a Teams discussion without leaving the software page context.

It’s simple as 1-2-3. Initially, you click a button to start a discussion. Secondly, you select a Teams or Channel you want to post the discussion. Finally, you add your discussion text. A link to the current page (the page you started the discussion) will be automatically appended to the conversation, and team members will be instantly alerted to view the page (e.g. an incident, document, or sales opportunity) and reply to the discussion.

This will drastically reduce time to solve problems, take faster decisions, and streamline processes.

This feature will be introduced to all modern Office 365 customers in June, at no additional cost.

Ask us for a free trial

CAPA Power BI Report as One-Place Access for Continual Improvement

Corrective actions (CAPA) is the main asset to drive continual improvement. This is especially true in BPA apps for quality and medical compliance, because CAPA/action was designed to be the main cross-platform module to continually improve.

Power BI Action Report

The CAPA/action Power BI report provides a one-place access to verify actions effectiveness and overdue actions. 

This means, the CAPA/action module is a single point of access to verify company-wide improvement processes are efficient, like nonconformities, risks, indicators, controls, audits and more. Behind the scenes, prebuilt workflows ensure actions are effective prior to be completed.

With the prebuilt CAPA/action Power BI report, improvement teams have a one-place access to verify actions effectiveness, track overdue actions, and make their weekly meetings productive. Simply click any report graphic to filter actions by origin, effectiveness status, or responsible person. In a click of a button, users can open and update actions directly from the report.

Managers get access to consolidated actions and take faster decisions.

Like the opportunity pipeline for sales people, the CAPA/action report is the main place to go to ensure continual improvement, simplifying improvement meetings and boosting productivity.

Ask us for a free trial

BPA Medical GxP Software

Satisfy GxP Guidelines with our Medical GxP Software

This blog article is to explain how customers can operate BPA Quality and Medical software on Microsoft Office 365 in compliance with GxP (good practices) and regulatory requirements, such as FDA 21 CFR Part 11 Electronic Records, Electronic Signatures (21 CFR Part 11).

Our provider-hosted apps runs on SharePoint online, in the customer Office 365 environment. BPA app-related data, records and documents are stored in SharePoint online, as Software as a Service (SaaS) provided by Microsoft. The Azure Platform and Infrastructure as a Service (PaaS, IaaS) is needed by BPA apps for server-side operations. Regulated customers can decide to run their own dedicated Azure VM and decide when they want to upgrade BPA app versions.

Medical GxP Software Layers

BPAMedical365 is installed in the client Office 365 environment in compliance with GxP.

Achieving a compliant cloud-based solution requires well-defined controls and processes, with shared responsibilities between Microsoft, BPA and our customers. Microsoft has implemented a series of technical and procedural controls to help ensure the dependability (availability, reliability, security, integrity, accessibility, and maintainability) of Office 365. We won’t discuss these in this document.

BPA has implemented procedures for data protection and security of our Azure-hosted services and internal testing procedures of our apps.

Office 365 is delivered as a SaaS solution where customers are responsible for establishing proper data classification, governance and rights management, managing client endpoints, as well as account and access management. Microsoft is responsible for all aspects surrounding physical infrastructure, network and application level controls, and shares responsibilities with respect to identity and access managing, as well and client and endpoint protection.

Validation Shared Responsibilities

Shared responsibilities establishing GxP, image source: Microsoft Office 365 GxP Guidelines

Main GxP customer responsibilities when using BPA apps are related to Office 365/SharePoint:

  • Granting user access
  • Configure Office 365 and SharePoint audit logs
  • Enable list and library versioning settings
  • Define data classification and retention rules
  • Configure information rights management
  • Secure software and hardware used to access Office 365
  • Conduct end-user training
  • Manage Office 365 data inputs, processing, storage, and outputs for completeness, accuracy and timeliness

A formal process should be in place for change management that will ensure that application changes are implemented in a controlled manner. At BPA, our teams have implemented a robust software change process. Any new release is first tested and validated by the development team, then by the software testing team (automated and manual tests), followed by the whole BPA team prior releasing to clients.

Procedures should be in place to define the strategy for data recovery in the event of intentional or unintentional destruction and/or corruption of data. SharePoint Online applies recycle bin retention of data and documents for 90 days, and version control on document libraries.

A formal process should be in place to ensure that issues are raised, recorded, investigated, and resolved in a formal and controlled manner. Our community portal allows customers to log issues and alert our support team for a quick resolution.

Considerations for FDA 21 CFR Part 11 Compliance

As a SaaS solution provider, Microsoft is responsible for protecting customer’s data and ensuring the quality of their software solutions and services. Regulated customers are responsible for configuring available Office 365 and BPA app features and functional capabilities to address business and regulatory requirements (with BPA’s help).

The following table describes the features and capabilities of Office 365 and BPA apps that can be used to satisfy regulatory requirements of 21 CFR Part 11 pertaining to the management of electronic records:

Regulatory Requirements

Office 365/SharePoint and BPA App features

Generation of accurate and complete copies of records in both human readable and electronic form.SharePoint export to excel, Windows Explorer feature or audit trail log export.
Protection of records to enable their accurate and ready retrieval throughout the records retention period.Office 365 records retention functionality, SharePoint version history, Information Rights Management features.
User access controls to limit system access to authorized individuals.Azure Active Directory, Information Rights Management.
Secure, computer generated, time-stamped audit trails to independently record the date and time of user actions that create, modify, or delete electronic records.SharePoint automatically captures user names and date/time when data is created/modified. Office 365 audit log functionality.

BPA Electronic Signature features.

Enforcement of permitted sequencing of steps and events (as necessary)Power Automate workflows can be created to automate business processes.

Preconfigured modules for quality and compliance.

Prebuilt workflows for compliance document approvals, incident tracking, changes, risks…

Authority checks to ensure that only authorized individuals can use the system to perform permitted activitiesSharePoint security groups and user permissions.
Data input validity verification (as necessary)Azure Active Directory.

Considerations for the Validation of GxP Applications

In the context of the Office 365 SaaS cloud service model, the customer does not have control over the underlying infrastructure hardware and software components, nor to the application itself. Microsoft is responsible for managing and maintaining these components.

Medical Software Validation

Validation of infrastructure vs applications, image source: Microsoft Office 365 GxP Guidelines 

Validation consists of demonstrating, with objective evidence, that a system meets the requirements of the users and their processes and is compliant with applicable GxP regulations. As such, validation is performed by the regulated customer using BPA apps on Office 365.

As custom GxP applications interfaced with Office 365, BPA apps should be treated as a GAMP 5 Software Category 5 – Custom Application and tested appropriately.

BPA provides a quick start package for our customers to simplify the software validation process, including the following document templates and some BPAMedical365 test case examples.

BPA Software Validation Quick Start Package

BPA Software Validation Quick Start Documentation Package. 

This article was written based on the source document “Microsoft Office 365 GxP Guidelines” by Microsoft.