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.

Document Training Matrix

Make Sure Important Documents are Understood by Collaborators

With BPA Apps, we propose two ways to make sure collaborators are skilled to do their jobs. Both scenarios can be used together or separately.

The common approach is to define the required skills to accomplish a job and periodically assess collaborator skills for their jobs. In BPA app, the process outcome is an interactive Power BI skill matrix which can be filtered by collaborator, job or department for easy decision making.

Skill Matrix

Power BI collaborator skill matrix in BPAQuality365.

The second approach can be easily configured with your BPA modern Apps.

To accomplish their jobs, collaborators need to be aware of job-related compliance documents, like important procedures (SOP) or work instructions.

When publishing compliance documents, an automated workflow ensures the right collaborators are alerted based on related jobs with regards to these documents. Collaborators get an email alert or approval in Teams to view, read and understand these documents.

Distribution Alert

Example of a document distribution alert sent to collaborators.

Collaborator decisions on whether help is needed to understand documents or documents are understood are logged in the App.

As ideal reporting tool, the document training matrix is a Power BI dashboard to view documents by collaborators with their decision status (need help/understood). The interactive document training matrix can be used to instantly check who needs training on which documents, or the required training by job.

Document Training Matrix

Document training matrix in Power BI.

With BPA modern Apps, you make sure collaborators are skilled to do their jobs.

>> Ask us for a free trial

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

How BPAMedical365 Complies with ISO 13485 ?

Whether you are a medical device manufacturing organization, or a healthcare service provider, or even a supplier of materials or services, the international standard ISO13485:2016 requirements can be applied to establish and maintain a sound quality management system in your organization. The latest edition of the ISO 13485 standard has been released in 2016 and can be considered as the worldwide standard for implementing medical devices quality management systems.

The BPAMedical365 software application can be used by an organization for all stages of the life-cycle of a medical device. BPA has incorporated proactive and reactive tools to identify, evaluate, treat and monitor quality management processes and risks related to the management of medical devices.

The BPAMedical365 app has a user-friendly navigation grouping all important topics to meet ISO13485:2016 requirements:

 

Medical stakeholders

Stakeholder Management

These subjects are part of the ISO 13485:2016 clause to understand your organization and its context.

Customer requirements are determined and customer feedback is periodically measured with surveys. Customer requests are tracked in the system.

Suppliers are qualified and evaluated periodically with audits and supplier performance indicators.

The organization chart provides an easy way for collaborators to understand the organization and access relevant documents.

 

Medical processes

Process Management

As a general requirement for the QMS, processes need to be determined, measured and monitored. The process map makes it easy for collaborators to understand the value chain.

Medical process map

List statutory requirements and all applicable regulations (BPA Medical 365 is compliant to many worldwide regulations, such as e.g. MDR and FDA regulations).

 

Medical knowledge

Knowledge Management

As main documentation requirements, it’s needed to describe, control and manage procedures, documents and records to operate processes.

Prebuilt approval workflows including eSignatures ensure documents are approved by authorized persons prior being published. Targeted recipients will need to sign a training receipt when documents are published.

Document version history is tracked in the system. Retention policies can be defined for records.

 

Medical improvement

Improvement Management

As improvement requirement, it’s needed to continually improve efficiency of the QMS system through quality objectives, audit results, post-market surveillance, analysis of data, corrective actions, preventive actions and management review.

The audit module contains prebuilt workflows and power App to simplify audit management, including related actions and audit report generation.

As a management responsibility, it’s required to document procedures for management review.

Quality objectives are established and their related indicators are periodically measured.

Prebuilt workflows and reminder rules ensure corrective and preventive actions are completed timely and efficiently.

 

Medical risk

Risk Management

As a general requirement, a risk-based approach is needed to control processes.

Hazards and risks are identified and periodically evaluated based on ISO14971:2019 recommendations.

Controls are set to mitigate risks.

 

Medical files

Design Management

As a documentation requirement, medical device files need to be established and maintained for medical products.

Technical files are provisioned and approved with automated workflows, including eSignatures.

Design and development changes and their effects on medical files are tracked.

Product and process related risks are managed based on FMEA methodology.

 

Medical competency

Competency Management

In the resource management, collaborators shall be competent on the basis of appropriate education, training, skills and experience.

List required job competencies and periodically evaluate collaborator competencies to perform their job. Manage the needed training to operate processes.

Competency matrix BI reports will be automatically generated for collaborators, jobs and departments.

 

Medical resources

Resource Management

As a resource management requirement, process equipment need to be identified and maintained.

Automated workflows and reminder rules make sure equipment are verified and compliant.

The information asset register allows to identify and protect sensitive information and data needed to perform operations.

Built on Office 365, BPAMedical365 not only store data and documents in your secured cloud environment, but also include automated workflows, BI reports, and reminder rules to ensure your QMS remains efficient.

With Teams and SharePoint, our app include communication and discussion capabilities to move towards instant quality improvement for frontline and back-office collaborators on any device.

With AI and machine learning, the app will guide users to find the right documents and find similar events, boosting productivity.

>> 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.

>> Ask us for a free trial

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