Medical process map

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

AI for Document Search

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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imspex-medical

Imspex Medical

The key result from this partnership with BPA is that Imspex successfully achieved ISO 13485 certification in the span of nine months from signing the contract to being audited in September.

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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document jam

Easy Document Access for Everyone, on any Device

Document preview

Easy document access and preview on any device with the new BPA hierarchy/preview component.

Accessing work instructions and procedures by collaborators on the field is challenging for most organizations, but not BPA customers.

The new document hierarchy (tree view) + document preview component is now available at no additional cost for BPA customers using our modern apps with Office 365.

End users access their relevant documents in a few clicks by drilling down the same folder structure they are used to with a file server. The document preview instantly opens on the right side. “This tool brings ultimate experience to end users when accessing their relevant documents on any device, anywhere, without changing their habits”, claims Dr. Boris Lutz, CEO at BPA Solutions.

The component is flexible to be used with any document library e.g. compliance documents, technical files, etc. and extends SharePoint capabilities. The document preview add-in can be used with Microsoft Teams together with instant discussions and video conferencing, boosting productivity.

In addition, BPA apps bring other tools for end users to easily access documents starting from a graphical process map or a multi-level organization chart. These tools are 100% agile and can be combined to provide the best user experience when accessing documents, for any organization.

BPA apps leverage the powerful SharePoint search engine to find the right documents, based on content and attributes. BPA components include additional features to search in document attributes by typing free text.

The whole document management lifecycle is fully automated and completely transparent for end users. Prebuilt eSignature workflows make sure documents are approved prior being published, and end users trained.

BPA apps bring powerful features for end users to easily access their documents on any device, leveraging your existing Office 365 tools.

Ask Us for a Free Modern App Trial Now !

Office365-eSignature

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

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 !