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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Artificial Intelligence

Announcing BPA Cognitive Search

Great news for our clients! BPA Cognitive Search is announced to be released soon.

BPA Cognitive Search is an AI-driven tool for finding pertinent documents by asking natural questions to a chatbot. End users will love using it with Microsoft Teams on their preferred device, or in the BPA App interface.

AI chatbot to search for documents

Example of natural question asked and received answer in the AI chatbot.

The tool is intended to instantly retrieve compliance documents, technical files or other documents stored in BPA Apps. Documents similar to another document can be instantly listed, opened or shared with your colleagues. This will drastically boost productivity when working with documents!

Start using the chatbot directly in Teams and write some keywords about documents you’re looking for. Pertinent documents will be listed by decreasing matching score. Refine your search by finding similar documents to a specific document.

In the daily business, it’s great to be able to search and share documents while chatting. BPA Cognitive Search can be started from any Teams, channel, activity or chat. When selecting a listed document, a document card displays in the discussion flow, ready to be shared with your colleagues.

AI chatbot to search for documents

Sharing a document card with a colleague in Teams.

While on the move or on the shop floor, using the chatbot with your mobile device is the best way to quickly find relevant documents. Simply open the Teams mobile app and start typing a few characters to instantly get matching documents.

AI chatbot on mobile device

Get matching documents easily on your mobile device.

With BPA Apps, the AI chatbot can be displayed in the home page or any other page.

BPA Cognitive Search will be available as an optional extension to BPA modern apps. BPA will provide the chatbot and needed shared Azure services, ready to be used with your apps.

>> Contact us for a free demo

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.

>> Ask us for a free trial

Power BI Audit Report

Power BI audit report in BPA App.

Supplier Deviation Form Request

Simplify the Supplier Deviation Request Process with BPA Apps

It’s very surprising to discover that a lot of companies publish their Supplier Deviation Request (SDR) form on the web for their suppliers to download it. These forms are visible to everyone.

In this context, the entire SDR process is cumbersome, it requires a lot of manual work and the risk of error is high. Completed forms are emailed back to the client for internal approval. From the received email, a manual approval process starts at the client (email or paper-based). Once a decision is taken, it’s most likely communicated to the supplier per email, including attachments.

Make it easy and automated with BPA Apps and Office 365!

In this simple scenario, a Microsoft Forms is used to build a digital SDR form. The form can be embedded in your extranet portal, or the link to the form can be shared with suppliers.

Supplier Deviation Request Form

Example of a SDR Form built with MS Forms.

Once the form is sent, an automated Power Automate workflow starts and links the request with the right supplier in the BPA app. A PDF version of the SDR form is automatically created and emailed back to the supplier as a confirmation.

Your internal team is alerted (in Teams or per email) and an approval workflow starts. Selected team members are notified to review the request and complete it with engineering disposition and special instructions. In the last step, approval notifications are sent to the specified users and decisions are tracked in the BPA app.

Supplier Deviation Request Review

SDR internal review and approval process in the BPA app.

Optionally, the SDR process could automatically start a supplier nonconformity process in the BPA app.

Another scenario would be to include the supplier as a guest in a shared Teams and work jointly in an automated cross-organizational SDR/nonconformity process.

The benefits of automating the SDR process are obvious:

  • Reduce the lifecycle time for the whole process
  • Reduce manual work by automating alerts and reminders
  • Reduce risk of errors
  • Develop a modern image

Contact us if you’re interested to implement this scenario for your organization.

>> Ask us for a free trial

multilingual apps

BPA Modern Apps Go Multilingual

Great news for our multilingual clients, we have released new modern multilingual templates for our Quality, Medical and CRM Apps.

By installing a multilingual app template, clients will be able to use their app in 3 languages – English, French, German – with no need of any manual translation work. Users will access the app in their preferred language, as defined in their Office 365 profile.

French Version Example of BPAQuality365 multilingual version with French as a preferred language.

Other languages will come later, meanwhile any language can be added easily by translating the needed BPA or SharePoint resources.

For clients using our modern apps in one specific language, specific tags can be added to make resources multilingual, e.g. navigation links, buttons visible in pages or any BPA resource.

A migration tool has been developed to migrate existing localized resources from BPA classic to modern apps.

>> Ask us for a free trial

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.

>> Ask us for a free trial

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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