Simplify Supplier Qualification & Evaluation with BPA Apps

Supplier Management Flow

Typical automated supplier management workflow in BPAQuality365.

A typical requirement in quality standards is to qualify and evaluate relevant suppliers.

We make it easy and agile with BPA Apps to comply with regulations and meet your own supplier management needs.

An usual supplier management process flow in BPA App allows to:

  • register suppliers
  • categorize suppliers (e.g. by importance)
  • qualify suppliers (through a set of questions)
  • approve suppliers (through an automated approval workflow)
  • periodically evaluate suppliers (through an automated evaluation workflow)

Supplier Form

Example of a supplier qualification form with configurable qualification questions.

Suppliers can be registered in BPA Apps by filling in a digital form. The form is highly configurable to include the supplier importance (e.g. ABC analysis), address, qualification questions, and other attributes.

The qualification section of the form includes your dedicated questions, like

  • Is the supplier certified?
  • Is the supplier critical to your business?
  • Is the supplier contract higher than a certain amount?
  • Is the supplier operating in a prohibited country?
  • etc…

An automated workflow verifies answers to these questions and pre qualify or reject the supplier. If the supplier is pre qualified, an approval notification is sent to the concerned persons and the supplier gets updated as qualified or rejected.

A second automated workflow starts for the supplier evaluation. The evaluation form includes your predefined questions. Evaluation result is calculated, compared to the required acceptance level, and notifications are sent to the concerned employees. When needed, an improvement request is automatically sent to the supplier.

Forms, app pages and automated workflows can be easily configured based on your needs.

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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.

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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.

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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.

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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.

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Office 365 eSignature Video

eSignature for Everyone, on Any Device, with SharePoint and Office 365

Modern eSignature component to be used in your Office 365 environment.

For regulated industries, electronic signature is required for a QMS software to be compliant with FDA and ISO 13485 regulations. For any organization, eSignature makes sure only authorized users approve documents or records.

BPA has developed an innovative eSignature component to be used with our apps on any device, directly within SharePoint and Teams.

eSignatures can be used internally to sign compliance documents, technical files, investigate incidents, or replace any paper signature. It can also be used with external suppliers to sign nonconformities or any other usage.

In this video we demonstrate how easy you can sign a compliance document, and a nonconformity form with multi factor authentication.

eSignatures can be added on any form by a simple drag and drop and protect document content or selected attributes.

BPA eSignature component gives the extra security needed when approving items in compliance with medical regulations. It makes SharePoint a more secure platform when signing documents or records, with no need to manage complex item-level permissions. It’s perfectly integrated with Microsoft 365 and multi factor authentication.

BPA eSignature is available at no additional cost with our modern Quality-Medical-CRM apps on Microsoft 365.

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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.

Modern Office 365 CRM Software

Breaking News: Announcing Modern CRM App for Everyone

Provide your sales, service and project teams with a modern CRM app they can use on their favorite device, anywhere, with their preferred Microsoft tools.

BPACRM365 is dedicated to salespersons on the move and back-office collaborators to run on their phone, tablet or desktop, with their preferred Microsoft tools.

Unlike traditional CRM software, the app provides a robust collaboration platform for the whole company, because it’s powered by SharePoint and includes powerful search capabilities, document sharing features and tight integration with Office tools.

The app leverages robust technologies for instant discussions and video conferencing (Teams), process automation (Power Automate), reporting (Power BI) and more. You can select among options to extend app capabilities, like searching the CRM app while chatting in Teams, prebuilt Power BI reports, and prebuilt workflows.

Prebuilt Power BI reports give managers instant insights about sales, customer service rating, campaigns performance and projects health.

Thanks to modular components and advanced form capabilities, power users are independent to extend the app or develop new apps. Clients can self-deploy the app by accessing online documentation, tutorials and videos.

Give your sales, service and project teams a modern CRM app they can use on their favorite device, anywhere, with their preferred Microsoft tools.

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Switching from Individual to Team-Oriented Quality

Quality with BPA & Microsoft Teams

Team-oriented quality and instant collaboration with BPA Quality software on Microsoft Teams.

Compliance is not the matter of just a few individuals (usually a “Quality Team”) but the concern of everyone in an organization. As a result, a centralized quality department is not enough to deliver a quick and efficient process improvement outcome.

Historically, quality circles were successfully introduced by organizations for implementing job-related quality improvement processes. The question is how to do this in a digital world?

The answer is to replace traditional email-oriented workflows by flexible “problem-solving” teams.

Microsoft Teams brings tools to instantly create teams and select members with instant collaboration capabilities on any device.

Our latest generation of quality software runs on Microsoft Teams, bringing agile team-oriented quality improvement capabilities with increased reactivity through instant conversations.

Together with Microsoft, we investigate new areas to deliver modern productivity tools for frontline and back-office workers, on any device.

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Simplifying Audit Management with Office 365/SharePoint

Innovative approach for managing audits by using BPA Quality and Microsoft Office 365 technologies like Flow for automation, Power Apps for mobility and Power BI for advanced reporting.

Managing audits or inspections is not an easy process. Typical considerations when managing audits include: audit planning and preparation, audit execution – e.g. with a mobile device, treatment of findings and follow-up actions, audit report preparation and sharing, audit monitoring, notifications to the concerned people, audit process validation, and business intelligence.

The audit module in BPA Quality lets you track any audit, like internal or stakeholder audits, quality, health, security, environmental, or data privacy audits or assessments.

A configurable workflow – built with Microsoft Flow – automatically alerts the right persons throughout the entire audit process, update the audit status, enforce all questions to be answered and actions to be compliant prior closing. The workflow generates new audits automatically based on the audit frequency, avoiding manual audit planning.

In this example, the audit is executed by using a simple mobile app. The app was created with Power Apps and it’s completely configurable. The auditor goes through each question and set compliance with notes and append photos if needed.

Finally we present a simple business intelligence report built with Power BI, with no code. The report lets you check the coverage of your audits, here by ISO 9001 clause. By selecting a clause, the report will dynamically filter audits where this specific clause was audited, questions that have been asked and the related number of findings.

Together with Office 365 technologies, we bring tools to improve traditional business processes.

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