Compliance Document Management for the Medical Industry

Compliance document management is highly regulated in the medical industry. BPA has developed specific tools and automated workflows to comply with medical regulations, like ISO 13485, FDA part 11, MDR and others.

BPA eSignature

Document preparation area with approval eSignatures in BPAMedical365.

We designed different areas in BPAMedical365 to prepare and approve documents, publish approved documents and train collaborators, and to publish effective documents in PDF format.

The BPA eSignature component makes sure only authorized people sign by using Microsoft multi-factor authentication with face recognition or other procedures.

eSignatures will show as invalidated when the protected document content is changed and selected users will be notified.

BPA eSignature

BPA eSignature field in the document properties form.

We developed prebuilt automated workflows for document approval and publication. Approval workflows ensure documents are signed by authorized users in the different steps, and prevent the same signer to sign multiple steps.

Trainees will be invited to in-class document training sessions. Collaborator knowledge on documents can be tested with simple Form quizzes. At the end of the process, documents are converted to PDF and published as effective.

Medical Power Automate Workflow

Prebuilt automated workflow for document publication on Power Automate.

Together with Microsoft 365 technologies, BPAMedical365 simplifies your journey to be compliant with medical regulations.

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Modern graphical charts

Announcing Modern Graphical Chart Components

Another great news for customers, modern chart components will be progressively released with our modern apps, and available for all clients at no additional cost.

Modern graphical charts in BPA

Modern card and gauge components, soon to be released with BPA modern apps.

BPA Chart components is a simple option for displaying consolidated graphical data in BPA Apps, with no need to manually handle data.

Our objective is to provide easy graphical reporting capabilities for clients looking for a simpler alternative to Power BI.

BPA Charts and Power BI reports can be used jointly, for example to grant access to simple reports for everyone with BPA Charts and grant access to business intelligence reports for selected users.

First chart components to be available will be cards and gauges, soon to be released.

Other chart components will come progressively, like bar charts, column charts, pie charts and others.

Stay tuned it comes soon!

Audits made easy

Audit Management Made Easy with BPA Audit Power Apps

As a sponsor of the next coming ISO 9000 & Audits World Conference, BPA is proud to present an integrated solution for audit management, including a prebuilt generic Power Apps for auditors.

Audit Power Apps by BPA

Auditors can simply touch the screen to complete an audit with their preferred device, even offline.

The audit Power Apps was developed to be generic and ready to be used by any type of organization. Auditors can use it on any device, like a tablet, even while offline. Compliance for each question can be set by simply touching the screen. During the audit, photos can be taken and voice recorded. The app content will be automatically synced back in the BPA software.

The audit preparation is done in the BPA software. Prebuilt automated workflows provision audit questions for the selected requirements. Any type of audit and regulation is supported.

After the audit, any finding and corrective action is added in the BPA software. Automated workflows alert members in Microsoft Teams and selected responsible persons.

An audit report can be generated in a click of a button, consolidating all data and photos in a formatted report template.

We provide prebuilt Power BI dashboards to view audit coverage and key audit metrics.

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Power BI Audit Report

Power BI audit report in BPA App.

Risk management

Make Risk Management Easy and Efficient with BPA Apps

BPA modern apps for quality and medical compliance include many modules for risk planning with the objective to develop a preventive risk mindset for the organization. Our components are very flexible to adapt to any risk methodology and comply with ISO 14971 recommendations.

We introduced 2 levels of risks in our software. Point risk analysis (initial risk and residual risk assessment after mitigation) is done for nonconformities, changes, incidents and other modules. Continual risk analysis is performed for enterprise risks and high residual risks.

Initial and residual risk values for nonconformities

Initial and residual risk values for nonconformities.

The enterprise risk management module includes prebuilt automated workflows to provision risk values based on assessment frequency.

Enterprise risk portfolio

Enterprise risk portfolio with continual risk assessment values.

Let end users know about your risk methods with our configurable help panel.

Help panel with risk matrix and factors

Help panel with risk matrix and factors.

Medical hazards are periodically assessed with a risk class ranking and risk priority ranking.

Medical hazards

Medical hazard details with potential hazard, risk class ranking and risk priority ranking.

Power BI reports display consolidated risk data in configurable dashboard.

GAMP 5 hazard report

GAMP 5 hazard report with Power BI.

Process and product risks are evaluated based on FMEA methodology. The tool is flexible enough to group FMEA risks is folders (e.g. by product) and copy/paste and update risks with the same agility as a spreadsheet.

FMEA risks

Copying and assessing FMEA risks by using the grid mode.  

As a conclusion, BPA apps and components provide agile components to adapt to your risk methodologies and regulations (ISO, internal control,…).

With Office 365, we propose a secure and robust platform for risk management, including prebuilt automated workflows, Power BI reports and instant discussions with Teams.

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Management review

Performing Management Reviews like Audits

The management review process requires top management to periodically review the Quality Management System to ensure its continuing effectiveness.

With BPA Apps we propose different modules to simplify the management review process.

Performing a management review works like an audit for specific clauses to review, like risks and opportunities, changes, supplier performance, customer satisfaction and more.

The good news is, the input information to prepare a management review and output data to consolidate in the management review report is already available in the different BPA App modules. This information just needs to be consolidated in Power BI reports.

The app guides your team to execute a management review by evaluating each input requirement and analyzing the related Power BI report, setting compliance and follow-up actions when needed.

Management Review input requirements

MR input requirements are automatically set by the App, facilitating the review execution.

We propose prebuilt Power BI reports to simplify the management review execution. Power BI reports can be exported as PDF documents and be appended to the review report.

KPI indicator Power BI report

Reviewing indicator performance in a prebuilt Power BI report.

The management review report can be produced by a click of a button. The generated report includes compliance for each input requirement with your notes and Power BI dashboards can be appended in the report.

Management review report

Example of a management review report produced by a click of a button.

Using the audit module for management reviews is a simple configuration in your BPA App. As a benefit, auditors can use the BPA Audit Power App to execute management reviews with a tablet, even offline.

Simplify management reviews and save time when producing MR reports by using the audit module in BPA Apps.

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Using AI for Searching Documents by Asking Natural Questions

AI for Document Search

BPA is currently working on a project to augment human intelligence with AI tools to help end users searching for documents by asking natural questions and find similarities.

“Clients are using BPA apps to manage hundreds of compliance documents, procedures and work instructions. Artificial Intelligence will help end users to find relevant documents by asking questions in natural language”, said Dr. Boris Lutz, CEO at BPA Solutions.

For this project, we leverage existing Microsoft technologies used by our clients and aligned with BPA Apps on Office 365. The main goal is to avoid custom methods and coding.

When working with BPA Apps on Teams or SharePoint, end users can ask a question to a bot and refine search by clicking a category of documents. A list of matching documents will be displayed and users can rate results for the system to learn and improve over the time.

Later, the same technology will be applied to other modules in BPA Apps, like searching for similar nonconformities or events.

The solution architecture includes many Microsoft Azure services, like bot services, cognitive services for language understanding (LUIS), storage services and monitoring services. BPA will offer these AI services as optional power extensions to our apps.

BPA’s main objective with this project is to bring prebuilt AI tools ready to be used with BPA Apps to help clients improving the quality of their products and services.

Stay tuned, it comes soon…

Reminder

Introducing Intelligent Reminder System with BPA Modern Apps

Great news to make your work more efficient, BPA’s intelligent reminder system is now available for clients using our modern apps.

The problem with typical workflows or reminder tools is the quantity of sent notifications. Power Automate workflows are triggered each time an item is added or changed, sending a specific notification. Nowadays, users get too many emails and reminder notifications will be lost among them.

With BPA’s intelligent reminder system, end users get one single email for all items pending their attention, e.g. my late actions, or my pending documents to approve.

The tool allows administrators to set reminder rules with advanced conditions, select metadata to deliver rich text notifications to the right persons, and pick days, time and frequency when notifications should be sent.

Interactive reminder cards work like checklists, allowing end users to dynamically set their job done for each item. This will boost work efficiency.

BPA-Reminder

Example of an interactive reminder checklist notification with all documents pending your review.

With BPA’s intelligent reminder system, you will drastically reduce the number of reminder notifications sent and improve efficiency of your business processes.

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Document Preview on Office 365

Introducing BPA Document Preview for Ultimate Document Management

BPA Document Preview component on Microsoft Teams and Office 365.

This is great news for end users – BPA Document Preview brings a fantastic user experience when working with documents on any device.

We designed our document preview component to simplify document access, without changing end users habits. We keep your existing file server folder structure on the left panel and display a large document preview on the right side when selecting documents.

“We reached our goal to provide end users with a simple tool to access their documents in a few clicks. In one page, users can preview documents, view important attributes and signatures, and propose document changes.”, said Dr. Boris Lutz, CEO at BPA Solutions.

BPA Document Preview provides a powerful “searching by typing” cross-folder searching tool. The global search engine works like Google and search for any data or document in the workspace. Not only attributes but the whole document content is indexed.

To comply with regulations, we need to make sure end users read and understand their relevant documents. Prebuilt eSignatures workflows ensure document are approved, published and the concerned users have read documents. With quiz forms, users can verify their knowledge about important procedures.

eSignatures bring additional security by using multi factor authentication, and protect documents from being changed.

Not only compliance documents but technical files can be easily previewed by frontline and field collaborators on their device with Microsoft Teams or a browser.

By syncing documents in OneDrive, users can access documents with their file explorer, even while offline.

Get the best user experience when working with documents thanks to BPA and Office 365 technologies.

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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.

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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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