Announcing Software Validation Package with BPA Apps

Software Validation Flow

The BPA software validation package includes documents mentioned in this process flow.

In regulated industries, it’s required to validate any software which has an impact on the delivered products. The concerned software are typically used for design and development, production, monitoring and measurement, quality and document management activities.

According to ISO 13485:2016, MDF and FDA, evidence is required that the software specifications are continuously in accordance with user requirements.

For many reasons, software validation is beneficial for organizations. It saves money by discovering weaknesses or defects before installing the software (hazard analysis). It helps to select the most suitable software and complete the project on time, without exceeding the budget.

Software validation requires several questions to be answered, like:

  • what is the purpose of the software?
  • what makes you think that the software is functional?
  • can you tell when the software is not working?
  • what are the risks of software shutdown and what will be the impacts?

As a Quality, Risk and Document Management editor, our software is concerned by validation. We are currently working on a software validation package to help clients with the BPA software validation. The package includes several documents and templates mentioned in the above process flow.

The BPA software validation package is the most economic option for organizations to validate our software. Still, complete test cases and evidence need to be prepared by the client, based on the deployed software modules and configurations done.

>> Contact us to know more

Simplify Medical Device File Management with BPA Software

Medical Device Files

Automated provisioning of medical device files with Power Automate and BPA software.

Medical device companies need to comply with regulations like ISO 13485, FDA part 11 and MDR to obtain a conformity mark to distribute their products.

One of the requirement is to establish and maintain medical device files, including medical device intended use and instructions for use, labeling, product specifications, and more.

It’s difficult to maintain accurate technical file templates across the whole organization for all products. Each file is usually linked with a specific approval process and the whole document set should inherit some document properties.

BPA has developed a Power Automate workflow to provision medical device files for any product by submitting a simple request. The needed file structure is automatically generated and each file is associated with an independent approval workflow. Automated rules will update file properties with the right product or project.

As a result, organizations have an automated system to generate accurate medical device files with no risk of manual error. Automated rules and approvals drastically reduce time to prepare the needed technical documentation.

The medical device file module can be easily configured with your BPA software on Office 365.

>> Ask us for a demonstration

Simplify Audits & Inspections with the New Audit Power Apps

BPA Audit & Inspection App on Microsoft Power Apps.

The audit app is dedicated to auditors or inspectors working on the field, on production lines, or visiting stakeholders. It can be used with a mobile device anywhere, even when no internet connection is available. The app runs on a web browser or Microsoft Power Apps.

The app is designed to work together with BPA Quality on Office 365. The audit preparation, like selecting questions is done in the full-featured BPA software. Follow-up actions are also tracked in the back-office software, together with dashboard and Power BI reports. Prebuilt workflows – running on Power Automate – automate the whole audit process.

The audit app reads data and questions from the BPA software. While auditing in offline mode, data will be stored in the app and uploaded to the BPA software once a connection is available.

For each question, auditors can touch the screen to set compliance and take photos, record voice or upload documents as proof of evidence.

As a conclusion, the BPA Audit App brings auditors & inspectors the best experience while auditing, even when no connection is available. The back-office full-featured BPA software consolidates audit data together with other modules to continually improve compliance and performance.

>> Ask us for a Product Presentation

Automate Processes With Workflow Templates

Introducing New Prebuilt Workflow Templates on Power Automate

Automate Processes With Workflow Templates

Process automation is a key factor when working with our business software solutions. By automating processes, organizations reduce time to run processes, reduce manual work and related errors, and improve performance.

We have developed prebuilt workflow templates with Microsoft Power Automate, ready to be used with our software solutions. Workflows have been designed based on good practices learned from previous projects, and years of experience in the compliance area plus Power Automate technologies.

As a result, our workflow templates cover 95% of clients expectations with no need to spend time reengineering processes. Yet, they are agile enough to be adapted if needed. Clients can simply import workflows and connect them to their BPA software.

Prebuilt workflows have been built to match our new coming BPAQuality365 modern app. They can also be used on top of our existing Quality 365 classic app, with little adaptations. Existing workflows will be constantly improved and new ones will be developed in the future.

>> Discover our Workflow Templates

Audits Made Easy with the New Audit Power Apps

Audit management is not a straightforward process and includes different steps for planning & preparation, execution, follow-up, and closing.

At BPA, we have developed tools to simplify the overall audit process:

  • The audit module in BPA Quality is the place to plan and prepare audits by selecting questions for any quality standard or inspection type.
  • An automated workflow send reminders to the concerned persons and calendar invitations to auditees.
  • While auditing, the new Audit Power Apps is used by auditors anywhere, even offline, to set question compliance by touching the screen, take photos and record voice.
  • Back in the office, auditors review data and multimedia in the BPA Quality software, and track follow-up actions until they are effective. Powerful BI reports present consolidated audit metrics.

By providing the right tools for the right activities, we maximize auditors experience throughout the whole audit process.

Audits Made Easy, Even Offline

The new Audit Power Apps is designed for maximal user experience while auditing.

The audit Power Apps is designed to run on tablets or phones and gives ultimate experience while auditing, even when no Internet connection is available.

The full-featured BPA Quality software is used to prepare audits, select questions, collect auditors data and multimedia (from the audit Power Apps), track follow-up actions, and display BI reports.

Audit page with related questions in the BPA Quality software.

Process automation (using Power Automate workflows) makes sure the concerned people are reminded about the audit, and ensure follow-up actions are completed and efficient.

By providing the right tools when they need it, we maximize auditors experience, simplify the overall audit process, and enable continual improvement.

>> Request for a Free Trial

Introducing BPA List Search App on Microsoft Teams

Search and share information from BPA directly within a chat conversation in Microsoft Teams.

Over the past months, we investigated different ways to achieve 2-ways communication between our SharePoint apps and Microsoft Teams. First, we explored a new way to solve problems with instant discussions. Secondly, we looked at adaptive cards to better interact with external stakeholders.

Today, we proudly introduce a new app to search and insert information from BPA directly within a chat conversation in Teams. The app prevents users to switch context away from the discussion, find the needed information in BPA and return back in Teams to continue the conversation.

The BPA List Search App works with desktop, web and mobile versions of Teams. In one click while discussing, allowed users can start the app and search for a specific record in a list. Matching records will be displayed by typing. When selecting a record, an easy-to-read card will be appended in the conversation, showing record information with a button to open contextual details in the BPA software (and BPA software will soon run on Microsoft Teams as well).

For example, you can use the app to retrieve a specific nonconformity while discussing with your compliance team. By opening the nonconformity in BPA, your team gets all details about the current incident. In a different context, while discussing with your sales team, you could search for a specific sales opportunity and share details.

The BPA List Search App brings useful business information to workers on the field or on the shop floor and back-office collaborators, anywhere, on any device, when they need it. The app covers the gap between structured business content (in BPA apps and SharePoint) and unstructured instant discussions in Teams.

As a result, people take faster decisions and organizations, processes become more efficient.

At BPA, we truly believe instant collaboration is becoming the next move in digital transformation.

Contact us if you’re interested to view a product demo or use it for your organization.

>> Access the BPA List Search App Page

Introducing BPA Power Extensions on Office 365

BPA Power Extensions are powerful add-ins to extend capabilities of your existing BPA software on Office 365.

BPA Apps run on SharePoint with Office 365 and natively interface with technologies like Microsoft Teams for instant collaboration, Power Apps for mobile solutions, and Power Automate for process automation. With BPA Power Extensions, organizations will discover the almost unlimited capabilities of Office 365 by using our business applications. We have grouped extensions in 3 groups, by technology:

Instant Collaboration with Teams Apps

Microsoft Teams is used by millions of users for instant collaboration. Teams can be used as “interface” to BPA Apps for accessing or adding data. A new App had been released for searching and sharing business information in BPA Apps while discussing in Teams, without leaving the chat box (view video here: BPA List Search with Teams)

Workflow Templates on Power Automate (Flow)

Microsoft Power Automate, formerly named Flow, is becoming the most powerful process automation tool on the market, bringing a lot of cross-technology automation capabilities and connectors. We have developed prebuilt workflow templates to be plugged in your BPA Apps, like compliance document, nonconformity or audit workflow sets. Process automation brings information to the concerned users on the tools they are working with, productivity is improved and cost is reduced.

Mobile Solutions on Power Apps.

We are working on mobile solutions with Power Apps to give the best user experience and ergonomics for processes like inspection, audit or incident reporting. These mobile apps run on mobile phones and tablets, and can be used by workers on the field or production lines to register incidents or controlling items by taking photos, videos or recording voice.

>> Access the BPA Power Extensions Page

Building a Community Portal App on Office 365

Community portal app built with BPA’s no-code app building platform on SharePoint/Office 365.

A community portal is a great way for any organization to centralize communication with their communities of clients, partners, stakeholders, or employees replacing inefficient emails. Portals can be used for different purposes, like help desk/ticketing, customer service, HR or others.

In this example, we have built a community portal app on Office 365 and SharePoint, using BPA’s app building platform. The app is completely configurable and was built in one day with no code!

The community portal app can be used as a standalone solution or can be connected to other BPA apps like CRM or Quality and compliance. At BPA, we are using a community portal since years to better serve our clients, answer tickets rapidly, share tutorials, documentation, FAQ, grant access to software packages and release notes.

With Office 365 and SharePoint, it’s possible to grant a secure guest access to users outside your organization (for example client organizations). External users can access a shared community portal with their Microsoft account or a non-Microsoft personal email with no Office 365 license needed (e.g. using a gmail account). External users will have limited permissions to access the community portal, post requests, view their own requests only, and access shared documentation in read-only.

Once a request is logged, it’s automatically linked with the right client organization and contact person. A discussion can be started between the client organization and the internal support team. Alerts are automatically sent to both parties. Documents or images can be attached to discussions. Internal discussions are not visible to the client organization.

The community portal app is be a perfect match for small and mid-sized organizations running on Office 365. The app will drastically reduce time to answer client requests, improve service efficiency and increase stakeholders satisfaction.

Ask us for an online presentation !

Integrated Quality + Information Security Compliance with Office 365 & BPA Apps

Combining Quality + Information Security – like required by ISO 27001 or GDPR – with BPA Quality on SharePoint/Office 365.

There are a lot of similarities in ISO clauses/chapters for quality (9001), environment (14001), information security (27001), health and safety (45001) and others. This means organizations can use the same tools to setup a “global compliance system”.

Continual improvement is best described by the Deming’s wheel (Plan-Do-Check-Act). Processes, objectives, risks, documents, audits, etc. are the tools to support continual improvement regardless the standards in place.

Let’s follow the PDCA approach to integrate an information asset register with your existing QMS, like required by ISO 27001 or GDPR regulations. For each value-added process, it’s required to identify data/document flows, what kind of data/document is stored and how.

This video presents a scenario to integrate information security with BPA Quality on Office 365, by simple configuration with no code.

In this example, we start from the overall value-added process map and drill down a process to view related compliance documents, audits, indicators, etc. The process data flow has been published in the QMS document library.

The information asset register has been created in the BPA app starting from an existing Excel register. Information assets are added with their required attributes, like data classification, retention and others. Significant assets with sensitive customer data requires a risk analysis. Controls need to be applied for assets with sensitive data.

The same approach can be used for environmental aspect, health and safety registers.

As a conclusion, it is possible to extend your QMS to a global compliance system by integrating new processes. Using a digital app like BPA, you can convert any spreadsheet to a new data register and connect it with the existing modules for continual improvement.

Ask for a BPA Quality Free Trial Now !

Improving Cross-Company Collaboration with BPA, Teams & Office 365/SharePoint

Improving cross-company collaboration, with Teams, Power Apps, Power Automate and BPA Quality on SharePoint/Office 365.

Cross-company collaboration is complex, even in the digital world. Emails remain the traditional way to communicate with suppliers, customers and external stakeholders. However, emails are personal, not formatted and not very efficient. Using self-service portals with external stakeholders is a better alternative, however it’s more complex to setup, cost is higher and portals are not flexible to adapt.

Microsoft Teams with Office 365 brings new tools for improving communication with internal or external stakeholders. Teams is a tool for instant discussions, meetings, and file sharing. It’s now possible to post forms in Teams (using adaptive cards), which opens new doors for better cross-company collaboration.

This disruptive scenario presents a client organization improving collaboration with a major supplier using Teams. By receiving a supplier nonconformity, the client register the incident using a mobile device and the supplier gets an automatic Teams alert. A form is posted to the supplier to determine actions regarding the nonconformity. Finally, the supplier gets periodical performance indicators from the client.

In this example, Teams is used as an “unstructured” front-office collaboration tool while BPA Quality is the structured back-office software to track all data, decisions and actions. Teams is well adopted by growing number of organizations. New cool features are expected soon, like Talkie Walkie, task management, bringing Teams to shift workers and the shop floor.

At BPA, we think instant collaboration is the future of Quality. By replacing inefficient emails, heavy portals and traditional task workflows, instant collaboration improves communication with internal and external stakeholders. Benefits are numerous, sharing Teams with external users involves no additional cost for the client (Teams is part of Office 365) and it’s no charge for external stakeholders (they get invited by the client).

As a conclusion, BPA software and Office 365 provide new tools to reach Quality 4.0 and improve cross-company collaboration. This no-code scenario can easily be configured and implemented for any type of organization.

Request for a BPA Quality Free Trial Now !