How a Quality Approach will facilitate Your GDPR Journey

GDPR will be enforced in 4 months. Any company located in Europe or dealing with European companies will be impacted.

To be compliant, organizations have to answer complex subject access requests, track data assets, manage voluminous GDPR documentation, plan audits, identify risks, and set controls, paying out exorbitant fines if any breach occurs.

When reading the new regulation, this sounds horribly complex.

So, where should you start? How can you make it work for your organization?

Let’s take a closer look at important GDPR management processes:

  • Identify data-related assets
  • Lead GDPR assessment audits
  • Identify risks and non-conformances
  • Implement controls and corrective actions
  • Treat customer requests
  • Set objectives and indicators

Does it sound familiar to you?

These processes are exactly the same as in a Quality Management System (QMS). This is great news because you can reuse the same QMS approach to manage your GDPR system.

From a regulation point of view, GDPR is not very different from ISO 27001 for IT security. We can imagine the upcoming versions of ISO 27001 or even ISO 9001 will include the main GDPR requirements.

In practice, it is a good option to include your quality team in your GDPR project journey as they are already familiar with the processes and tools.

BPA Solutions has developed an all-in-one GDPR compliance solution built on our proven and award-winning quality and risk management software. BPA GDPR Compliance runs on the GDPR-compliant Microsoft Office 365 technology.

BPA makes GDPR compliance easy and affordable.

Learn more about our GDPR solution

3 Reasons to Move Away from Paper-Based Quality and Risk Processes

If you’re part of the Quality and Risk Management team at your organization, you know that the job isn’t easy. Avoiding or mitigating risk to maintain the highest quality for your company’s product or services oftentimes entails numerous disparate and even tedious processes. Further complicating things – many organizations today still rely on paper-based processes: hundreds of disconnected, hefty Excel files, a seemingly endless number of filed-away compliance documents, and more.

Luckily, in today’s technology era, there are integrated digital solutions that exist to simplify the jobs of Quality and Risk Managers. The problem? Not everyone is embracing digital transformation. If you’re still finding yourself buried in Excel files or stacks of paper documents, here are 3 reasons you should embrace a digital QMS solution.

  1. Efficiency is key to any organization

Regardless of what industry you’re in – you and your colleagues don’t have time to waste sifting through stacks of paper documents or clicking through Excel files. It’s a massive waste of time, energy, and ultimately – company dollars. In fact, companies today can lose up to 20-30% of revenue due to inefficient processes. Stop sifting through piles of paper and move to an automated system to increase efficiency and reduce unnecessary company spend.

  1. Reliance on paper increases risk

If you are focused on quality and/or risk management, your job is to reduce potential risk in your business – not add to it! So why rely on cumbersome processes that could potentially increase room for error? What happens if that Excel file containing patient or customer information gets unintentionally deleted, or that intake form lands in the trash rather than a file cabinet? The truth of the matter is that relying on paper-based processes pokes holes in your ability to maintain quality in your organization – widening your room for error and opening your business up to risk.

  1. Digital QMS solutions put the power in your hands

What if you could manage all your company’s important documents in one integrated system, in a format that enables you to easily identify compliance issues, areas for quality improvement, and KPIs? That’s what going digital with your Quality and Risk processes allows you to do. Having this information easily accessible and identifiable to those in management puts the power back into your hands. Rather than feeling lost, confused, or frustrated, your QMS can enable you to feel empowered and in control of your business.

Move away from archaic paper-based quality and risk management processes and adopt a digital solution to reduce cost, increase efficiency, and empower your organization – fulfilling the highest quality your organization can and the necessary compliance mandates. To learn more about the benefits of moving to a digital QMS solution can empower your organization, contact one of our quality experts at BPA solutions or read more here.

Build No Code Solutions Loved by Users

Does your organization hesitate between make or buy decisions for building business solutions? This shouldn’t be the case anymore.

You can never have too much time, money, know-how, or technical resources when building solutions for your most pressing challenges. Unfortunately, those are the components that are most often in short supply.

Many companies are hesitant to build applications for business that only they understand. But that doesn’t mean they don’t need them.

In-house development is rarely your core business. Developing in-house solutions is complex, costly and time-consuming. Hard-coded solutions are not flexible enough to meet continuously changing business processes and become obsolete when developers leave. Understanding business needs is challenging for IT professionals. Mostly, business has no control over IT solutions.

Embrace a No-Code approach to building the solutions with the resources you have today.

With BPA no-code solution builder, business people can create solutions in days, with a great user experience. Give the control back to business people when they need solutions that are quickly available and flexible to evolve with always changing processes. Spend time on business initiatives, not development efforts.

With BPA, you can re-allocate developers to configure, customize and improve solutions instead of starting from scratch and re-inventing the wheel again and again (don’t redevelop the bricks!).

By adopting BPA’s no-code approach you get simplified and streamlined LOB solutions with an efficient user experience. You can focus back on your business and save development cost.

BPA no-code solution builder is built on Office 365, including all the tools needed for scalable, secure and efficient apps to run on any device, anywhere.

BPA Quality and CRM apps are built with solution builder, take a look at our discovery sites.

The Ideal CRM Solution Dedicated to Small Businesses

Small and mid-sized businesses are strongly impacted by poor sales efficiency and complex CRM systems.

Financially fragile, small organizations are affected by revenue losses & poor conversion rates, they have no option for dedicated CRM resources and no time/money for complex CRM solutions.

An adapted CRM solution is critical for small companies to better know conversion rates and increase sales efficiency. Because sales processes evolve rapidly in small businesses, the CRM system needs to be very flexible. It has to work tightly with Microsoft tools used by sales teams. Ideally, important end user tools – like calendar, reminders, emails, collaboration, Office apps, CRM system – need to be in the same interface (yes, it’s possible!).

Big CRMs are costly, complex, not flexible, and not adapted to small organizations. These complex tools require dedicated resources and extra costs to work normally.

BPA CRM is an out-of-the-box solution dedicated to small businesses. It’s easy to use, efficient and cost-effective. The solution is built with 30+ modular functions. Non-IT persons can adapt the system very quickly.

BPA CRM runs on Office 365, including tools like instant discussions, team collaboration, Office applications, workflow automation, mobile solutions, powerful reporting and more.

BPA CRM probably gives the best user experience, because important end user tools are available in the same interface.

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BPA Quality Was Nominated by the European SharePoint Community

The European SharePoint and Office 365 Conference just terminated two weeks ago in Dublin, Ireland. 2,000 developers, IT professionals and Business Decision Makers have attended to learn from the world’s best SharePoint, Office 365 & Azure speakers.

We are very excited to have been nominated twice with BPA Quality, by the conference organizer, as finalist for the most innovative SharePoint solution and best Office 365 add-in.

This year the awards went to LiveTiles and KanBo! Congratulations, well-deserved!

“I’m very happy of this nomination because the competition is big. Congratulations to the whole BPA development team which has worked really hard to release our 365 apps. We have succeeded our challenge to have one single solution running on SharePoint 2013, 2016 and Office 365, with almost the same code.”
Dr. Boris Lutz, Founder & CEO at BPA Solutions

BPA Quality can now be installed in your Office 365 tenant. All native features from Office 365 are available, like instant discussions, collaboration, Office applications, workflow automation, mobile solutions, powerful reporting and more. The solution includes 30+ BPA modular functions to customize the solution to your needs, with no code. Power users are autonomous to extend the solution.

“It’s a fantastic opportunity for quality teams all over the world to have a ready-for-use digital quality and risk solution available in the Microsoft 365 cloud, including tools like PowerApps, Flows, Power BI, Forms, Teams and more.”
Belinda Schöni, Co-Founder & CEO at BPA Solutions USA LLC

Automation is the key to running an effective quality program. Become accustomed to lower risk profiles and simpler engagement on quality approaches. With BPA Quality and Risk Management, you can take a templatized approach to the most common quality and risk management functions and internal controls—keeping your focus where it belongs: on your business.

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Benefits of Digital Quality for Your Organization

Digital Quality Gives Executives a Cockpit to Pilot Their Enterprises

A QMS will not only guarantee the quality of your products but also the quality of all related processes to finance, design, manufacture, market, sell your products & services and get profits. In addition, the goal of a QMS is to obtain satisfaction of all internal and external stakeholders.

QMS

Because a QMS englobes all processes, it’s a very powerful management tool to pilot the organization. The QMS dashboard provides all important KPIs, risks and improvement opportunities to make sure key processes are efficient.

BPA Quality is an integrated QMS software providing the most powerful reporting tools for executives to pilot their organizations.

A Digital QMS Helps to Solve Pain Points in the Daily Business

Every business, regardless of size or industry, is concerned with the quality of its product and its overall risk profile. Now there’s a unified, simplified, automated, and easy-to-use solution to address those concerns head-on: BPA Quality & Risk Management.

For Quality, Risk & Compliance Managers, CFO and Process Managers, regardless of industry and company size, BPA helps to solve pain points like:

  • Manual processes
  • Outdated technologies
  • Disparate, cumbersome, and costly paper systems
  • Costly developments of data-entry ready solutions on top of SharePoint/O365

Digital Transformation Has Reached Quality Processes

Digital transformation has not equally reached all company services. HR and CRM processes are digitalized since years. In the contrary, QM processes are usually Excel and paper-based.

Digital quality will help Quality Managers to:

  • Save costs
  • Improve quality
  • Take faster decisions
  • Reach 365 daily quality
  • Develop a preventive attitude
  • Engage and motivate collaborators
  • Spend time on interesting activities

BPA is the First QMS Software Available on Microsoft Office 365

BPA Quality is the first and only all-in-one QMS solution running on Microsoft Office 365, interfacing with tools like instant discussions, team collaboration, workflow automation, mobile solutions, reporting and more. BPA Quality is the most advanced QMS solution in the market.

BPA quality

BPA Quality for Office 365 – Overview Video

BPA Quality is an all-in-one and interrelated Quality and Risk solution, built on Microsoft Office 365.

BPA is built to address the most common compliance standards including ISO9001: 2015, CFR 21 part 11 and others, regardless of industry and company size.

BPA helps you to engage with all collaborators, in order to make your QMS participative and to facilitate continuous improvement.

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Quality System CFR 21 Part 11 Compliant

How to Make Your Quality System CFR 21 Part 11 Compliant

In this article we will discuss major CFR 21 part 11 requirements. We will present how an Office/SharePoint-based quality management system complies with relevant regulations for the life science industry.

People who use systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and the confidentiality of electronic records.

 

Quality System CFR 21

This means an electronic system needs to clearly identify users and assign the right permissions to create, validate or read documents inside and outside the organization. Electronic signature makes sure authorized users can prepare and edit documents. Once a document is published, the system declares it as a record for the specified retention period. Information right management policies restrict users from copying or printing documents, even if documents are saved outside the system. Workflows enforce document approval and signoff. An audit trail has to be kept with a document throughout the document and record life cycle. Most of these technologies are part of native Microsoft Windows, Office and SharePoint.

Signed electronic records  clearly indicate the following information: the printed name of the signer, the date and time when the signature was executed, the meaning or responsibility associated with the signature. With Microsoft Office and SharePoint, digital signatures are stored as part of the document. Electronic signatures are stored as part of the audit trail and metadata associated with the document when signed as part of a workflow. The linkage between signature and document is maintained by the server.

Each electronic signature shall be unique to one individual. With Microsoft Office and SharePoint, Active Directory enforces a unique user ID and password for each user. Procedures and policies should be in place to ensure user credentials are periodically checked. Failed login attempts will be logged by Windows Server and related user accounts can be locked out.

Three topics need to be addressed when validating the system: installation qualification, operation qualification and  performance qualification. In the end, the system should perform to the end user’ needs.

The implementation of an electronic signature system must be simple for end users but rigorous enough to meet the organization’s need for record keeping within the organization.

BPA Quality is running on the latest Microsoft SharePoint and Office 365 technologies. BPA contains all necessary technologies to build a CFR 21 Part 11 compliant system. BPA Quality is cost effective and adapted to the needs of very small to large businesses.

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Proces map

Driving Efficient Risk Management

Risk management is a fundamental part of your Quality Management System. In the latest ISO 9001:2015 quality standard, risk management has become a central preoccupation.

Risk management is about developing a preventive attitude to avoid the occurrence of unfortunate events. In managing risks, companies can save resources, improve productivity and increase collaborators’ safety and health.

Not just used in banking or insurance organizations, an efficient risk management can have a direct impact on profits, revenue and business continuity.

A typical risk management process contains 4 main steps:

  • Risk identification
  • Risk assessment
  • Risk treatment
  • Risk monitoring

It’s good to start by defining company processes prior to identifying risks. A process map illustrates value added and resource processes in order to deliver valuable products/services to satisfy customers.

 

Knowing issues, indicators and risks for each process gives clear insights on how to make improvements.

There are 2 ways to identify risks, on the strategic or operational level. SWOT or stakeholder expectation analysis are great tools to identify strategic risks. In daily operations, issues, complaints, audits, correctives actions, indicators, etc. are typical events used to  detect risks. A recurring issue is a typical source for declaring a new risk.

 

 

Different methodologies exist to assess risks. A simple one is to assess probability/occurrence and impact/gravity of risks. The risk severity is the multiplication of probability by impact factors. The impact is sometimes expressed as a monetary value. In FMEA’s methodology (Failure Mode and Effects Analysis), the risk severity is the multiplication of three factors: impact, probability and detection. The risk severity is often displayed in a risk heat map for a specific period. A scorecard is an ideal tool to monitor risk assessment values over  time with their trends.

methodologies assess risks

 

High severity risks display in the red zone of the heat map. These risks need to be treated. Corrective actions are assigned to the process owners, to reduce the risk probability or impact. Periodical controls are set to monitor risks.

Risk compliance documents will be needed to describe your risk methodologies and procedures with their related instructions. These documents are usually part of your quality document management system.

Excel spreadsheets are not ideal to manage risks with their related actions and controls. Excel is a personal tool that is not adapted for collaborative work.

An integrated digital quality management software like BPA Quality will help quality managers to have a participative quality and risk management system.

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Build Professional No-Code Solutions With Office 365

We proudly announce the next coming release of our no-code solution builder for Office 365. In a few weeks, your functional collaborators will be able to build professional business solutions in hours.

Developing with Office 365 is complex, time consuming and expensive. Home-made solutions usually don’t meet user needs on the long term. Developers are not good at designing great UX and user experience is limited.

Build No-Code Office 365

BPA Solution Builder is intended for business users. SharePoint power users can build tailor-made solutions in hours with no development skills needed. It is like playing lego.

The product is non-invasive and behaves like any SharePoint site. It’s easy to create apps, views, columns and relations between apps.

When the lists and libraries structure of your Team Site are ready, build beautiful ergonomics, easy navigation, relational management by simple drag and drop on the page.

The solution remains completely flexible and we guarantee the best user experience.

>> Let us know if you’re interested to know more about BPA Solution Builder for Office 365.