Failure Catalogue Power Apps

Boost Productivity with our Failure Catalogue Power Apps

Workers on production and assembly lines have to take difficult decisions about product quality acceptance. They often refer to antiquated paper systems with low quality product images.

With BPA Incident and Failure Catalogue Power Apps, frontline workers take faster decisions without asking managers, boosting productivity.

Failure Catalogue Power Apps

The app can be used in clear or dark mode to search the failure catalogue or register incidents.

By providing tablets on production lines and cleanrooms, workers can search the failure catalogue, compare products with high resolution images, and take the right decisions about product acceptance from their working place.

The app runs on any device, like phones or tablets, interfacing with native device capabilities like geolocation and camera. Anyone can report an incident by taking photos, even offline, like supplier issues (incoming inspection), stakeholder visits, and internal issues.

The app interfaces with BPA software for integrated quality. An automated workflow ensures each step is done to prevent a similar incident to occur again. At the end of the 8D process, the incident is published in the failure catalogue including photos, remedies and client acceptance criteria.

Shift to Quality 4.0, boost efficiency of your production lines, and improve quality of your products by using our modern Power Apps for incident management and failure catalogue.

Ask for a free trial now !

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 the SharePoint App Catalogue.

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.

BPA Medical Quality Software

Breaking News: Announcing Medical Quality Software on Office 365

Complex medical device risk and quality management obligations are challenging for organizations and must be observed on a daily basis and down to the affiliate level or high fines caused by noncompliance can hurt the bottom line and damage corporate market positions.

We are proud to announce our medical quality and compliance software, to be installed in your secure Office 365 environment. BPAMedical365 includes the main modules of our quality and risk management software plus additional modules for product lifecycle management.

Medical Software Modules

BPA Medical Compliance software modules.

Built on SharePoint and Office 365, the software includes technologies to comply with GxP and regulatory requirements like FDA 21 CFR Part 11, MDR and ISO 13485. Additionally, BPA has developed an electronic signature module and prebuilt automated workflows to simplify your compliance journey.

BPAMedical365 can be used on any device with you favorite Microsoft tools, like Teams or SharePoint. With Teams, users have a single point of access to their medical quality system, instant discussions and video conferencing, boosting productivity.

Go a step further and reach Industry 4.0 objectives by using our Power Apps for incident registration, failure catalogue, audits and inspections.

We provide an ISO 13485 documentation kit, including a software validation quick start package, containing document templates to setup an ISO 13485 compliant system, ready to be imported in the software.

Ask us for an online presentation.

Medical Quality Software on Phone

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

 

Medical Device Quality Management Software for Small Businesses

Quality management software for medical device manufacturers is usually complex, expensive and out of reach for small and medium companies.

However this is no longer the case, BPA has just released an integrated quality and risk management software, affordable, flexible and adapted to small and mid-sized medical device companies. A new digital signature module has been developed to comply with 21 Part 11 CFR regulations (view video here).

Built on the CFR 21-compatible Microsoft Office 365 technology, BPA Quality and Risk Management is a cloud-enabled, secure, and scalable solution, delivering superior document management, workflow, collaboration and reporting tools in one single interface and providing an unequaled user experience.

No need for cumbersome and costly paper systems anymore, our digital QMS software facilitates communication between siloed departments, increases efficiency with automated processes and saves cost.

Office 365 + BPA Quality is the ideal QMS solution for small and mid-sized medical device companies.

Read more about BPA Quality