Synesis International & BPA Will Celebrate 10 Years of Successful Partnership

BPA and Synesis will celebrate the anniversary of their 10-year partnership in 2019. With business expertise and development skills in SharePoint and enterprise solutions, Synesis has been one of BPA’s most successful North American distribution and implementation channels. Clients include Hamamatsu, Integra, Unicom and Southwire.

Synesis International is a 25-year-old, manufacturing-focused, enterprise systems integration firm based in Greenville, SC. They specialize in long-term relationships and the delivery of key business systems – ERP and Quality.

Synesis has successfully implemented a fixed-bid, fixed-scope Document Control solution that rides on top of BPA Quality and SharePoint and is implemented quickly to specification.

SharePoint is well-established in the manufacturing space and that’s where Synesis thrives.  The distribution and implementation of BPA in manufacturing has been a successful, decade-long partnership and a major focus of Synesis. Together, we’ve been able to deliver solutions our customers value because they see immediate ROI.”  – Ricardo Studart, President, Synesis International

We are honored to have Synesis as partner. With Synesis, we have a strong Partner to serve the North American market, especially the manufacturing and distribution sector.” – Dr Boris Lutz, BPA CEO and Founder.

More about Synesis International on


How BPA’s Software Meets IATF 16949 Requirements for Automotive Industries

IATF 16949:2016 is an independent QMS standard, dedicated to the automotive sector, that is fully aligned with the requirements of ISO 9001:2015.

IATF 16949 includes specific requirements and core tools from the automotive industry, like:

  • Advanced Product Quality Planning (APQP)
  • Failure Mode and Effects Analysis (FMEA)

APQP ensures the voice of the customer is clearly understood, translated into requirements, technical specifications and special characteristics. APQP is typically used when introducing a new product, process or qualifying, evaluating new suppliers. From design to production, the APQP tracking sheet makes sure you go through each step and meet all needed requirements.


Screen Capture of BPA Quality & Risk Management, APQP example.

BPA’s software brings simple collaborative tools to track APQP projects with their milestones, related question sets, compliance and documents. Workflow rules ensure the right persons are automatically alerted to plan actions or mitigate risks.

Failure Mode and Effects Analysis (FMEA) is a structured approach to discovering potential failures that may exist within the design of a product or process. Discovering a failure early in product development using FMEA improves the product design and lowers cost. Important FMEA steps are to identify failure modes and assess their severity, identify causes and probability of occurrence, set up preventive process controls (detection). As a result, FMEA highlights Risk Priority Numbers (RPN) for each identified failure mode. Actions will be taken to mitigate high risks.


Screen Capture of BPA Quality & Risk Management, FMEA example.

FMEA is a collaborative process that can be easily tracked with BPA’s software, replacing inefficient spreadsheets.

BPA Quality & Risk Management is leveraged by the benefits of Microsoft Office 365 technologies.

Ask for a free discovery access now.


BPA Announces OnShore Technology Group as a Strategic Software Validation Partner

BPA Solutions is pleased to announce Chicago-based OnShore Technology Group as a strategic partner supporting global computer software validation. OnShore Technology Group is a leading Independent Validation and Verification (IV&V) firm delivering innovative products and professional services to support computer systems validation. OnShore’s ValidationMaster Enterprise Validation Management and Quality system is designed to seamlessly interoperate with the BPA Solutions Quality Management system. ValidationMaster features requirements management, incident management, validation test management and execution, validation reporting and dashboards as well as tight integration with BPA Solutions for advanced quality management and document control for validated systems. ValidationMaster is designed to manage ANY type of validation project from computer systems validation, equipment validation, process validation, cold chain validation and much more. The system is accessible via any Windows, Apple or Android device and is available either as a cloud subscription or on-premise installation.

OnShore Technology

OnShore also offers comprehensive services to support IV&V including ValidationPro (full-service, turnkey validation), ValidationCoach (interim validation coaching and team augmentation services), and ValidationOffice (Validation Staffing).

Valarie King-Bailey, CEO of OnShore Technology Group said, “The partnership with BPA Solutions is essential for our solution. Quality and Risk Management and critical components of the validation process yet many solutions require the use of disjointed, disparate systems to support this process. Our vision was a unified, cohesive solution for validation processes that brings together everything you need to support the full lifecycle of the validated process. The BPA Solution has critical advantages over its competitors in that it is SharePoint-based, it leverages the Microsoft solution stack, and is cost-effective and easy to deploy. We are pleased to join forces with BPA Solutions in our quest for lean validation processes that save our clients both time and money”, Valarie continued.

“With OnShore we have an experienced and independent software validation expert that brings a lot of value to our clients. BPA’s software together with SharePoint and Office 365 technologies and OnShore services bring the most advanced solutions for regulated industries.” said Dr. Boris Lutz, CEO at BPA Solutions.

More about OnShore Technology Group on

Software Validation

Software Validation with BPA Quality & Risk Management

Software validation is an essential, mandatory process for any life sciences company seeking to deploy enterprise software to manage any cGxP process or global predicate rule requirement. The ultimate goal of software validation is to help ensure confidence that systems are installed and functioning according to their intended use and that there is documented evidence to confirm it. Validation requires rigorous procedures to provide governance for the overall process and must be implemented and executed by those who have the requisite training to carry out such procedures. Validation is also governed by regulatory bodies including the U.S. Food and Drug Administration, EU Annex 11, ISPE GAMP 5, IEEE 1012:2016, Pharmaceutical Inspection Convention/Co-Operation Scheme (PIC/S Guidance) and many others which provide regulatory mandates, procedures and best practices to support computer systems validation for today’s regulated systems environments.

Software Validation

In the past, validation has been conducted primarily through manual, paper-based processes. As with any such process, it could be sometimes error-prone, inefficient and sometimes ineffective. Cloud-based computing and the advent of mobile technologies have changed the paradigm of validation yet, the mandate and principles of validation still endure. One must still confirm the installation or provisioning of validated systems to ensure that they are provisioned in a consistent, repeatable manner. One must also confirm the operation of such systems to ensure that each stated requirement is rigorously tested in a manner that will withstand global regulatory scrutiny. And finally, performance testing on validated systems in the cloud is critical to the overall adoption and success of the system. All cloud providers are not created equal, thus performance testing must be conducted with either simulated or live loads to ensure optimal performance under production system environment conditions.

All validation testing must be conducted in the context of a risk assessment for the system. The assessment of risk drives the level of validation due diligence required for any given system A formal risk assessment highlighting controls and mitigation strategies as well as a timetable for periodic assessment is in keeping with ISPE GAMP 5 requirements as well as many global mandates for validation.

The elephant in the room facing many validation engineers is that of cybersecurity. The challenge for validation engineers is how to ensure readiness and protect validated systems against the threat of cybersecurity. Our software validation Partner – OnShore Technology Group – uniquely inspired the term “Cybersecurity Qualification” or “CyQ”. In addition to conducting IQ (installation qualification), OQ (operational qualification), and PQ (performance qualification), OnShore Technology Group recommend a CyQ (Cybersecurity Qualification) to address the ability to identify, protect, detect, respond, and recover from cyber events from validated systems.

To support the rigorous requirements for the validation of BPA Quality & Risk Management software, OnShore has developed a unique service offering known as CloudMaster 365 Validation Accelerator For BPA Solutions. A Validation Accelerator is a service offering consisting of Enterprise Validation Management software coupled with requirements documentation, validation planning document templates, and ready-to-execute validation test scripts for COTS-based functionality to streamline and optimize the validation process saving both time and money. The Enterprise Validation Management software is designed to automate many of the time-consuming, manual and paper-based processes delivering a more agile validation process commensurate with today’s fast changing cloud-technology. Since validation is a process which must be repeated each time software changes, the annual subscription of the Validation Accelerator ensures that your test scripts are kept up-to-date with each major release.

BPA Solutions Welcomes Nut Consulting to their Channel Program

BPA Solutions – a Swiss-based software company providing leading regulatory compliance solutions – is delighted to welcome Nut Consulting to their channel program. Nut Consulting is specialized specialized in Microsoft Dynamics NAV, Office 365 solutions and provides the management, warehouse and production systems any company needs.

June 1, 2018

BPA Solutions – a Swiss-based software company providing regulatory compliance solutions – welcomes Nut Consulting to their channel program.

Nut Consulting

Since 2008, NUT Consulting SL – an ICT company located in Valladolid, Spain – is becoming a nationwide reference company in the food sector.

The company’s goal is to help their clients with their management systems, always looking for excellence and innovation and introducing digital transformation and “long-term relationships”.

Nut Consulting is specialized in the implementation and optimization of business solutions (ERP, CRM, BI) with Microsoft Dynamics together with home-made plant data capture systems.

NUT Sistemas offers infrastructure, cloud and security solutions.

Until now, the gap we had was to be able to provide our customers with a tool that would allow them to manage the “quality” that is absolutely necessary in the agriculture-food sector. With BPA Quality and Risk Management we have the solution for all our clients and prospects in the agriculture-food sector that we know so well”, said Luis Garcia, Nut Consulting’s General Manager.

We are pleased to have Nut Consulting as a new partner. With Nut Consutling, we have a strong Partner to deserve the Spanish market, especially the food and agriculture sector, with integrated solutions for regulatory and compliance”, said Dr Boris Lutz, BPA’s CEO and Founder.

About Nut Consulting

NUT Consulting SL is a Microsoft Partner, expert in the implementation of Microsoft Dynamics NAV and Office 365 solutions, specialist in the agriculture-food sector with several certified solutions as CfMD for that sector.

To learn more about NUT Consulting, visit

About BPA Solutions

BPA Solutions – Regulatory Compliance Simplified. Since 2001, BPA Solutions is a leading global provider of innovative business software solutions based on Microsoft Office 365 and SharePoint technologies. BPA develops ready-to-use regulatory software solutions – Quality, Risk, GDPR – to improve organizations’ processes, products, services and simplify regulatory compliance. BPA Solution Builder gives developers a wide range of integrated components to accelerate development and maximize user experience with SharePoint. Headquartered in Switzerland, with an office in Seattle USA, BPA is ready to support your digital workplace initiatives.

To learn more about BPA Solutions, visit

AI for problem soving processes

Implementing Artificial Intelligence for Problem Solving Processes

Problem solving is a universal process faced by all organizations when dealing with issues, complaints, incidents, deviations or non-conformances.

BPA’s development lab is currently exploring AI for predictive analysis applied to problem solving processes.

AI for problem soving processes

The developed machine learning algorithm compares similarities between new entered incidents and historical data, and suggests root causes, corrective actions for a quick and efficient solving.

The used algorithm was trained on the entire Wikipedia database for optimal similarity searching, not only looking for exact matches but also analogous matches that have the same meaning by using comparable terms, expressions and synonyms. For instance, when reporting a new incident “customer service was not good”, the algorithm will propose 3 root causes: lack of communication skills, lack of domain knowledge, lack of responsible behavior. In this case, the algorithm found a similarity with a previous incident “customer service delivered poor response”.

Behind the scenes, the process will compare new incidents with previous ones and calculate a correlation factor for each item. Suggested actions and root causes corresponding to the highest correlation factor will be proposed to the investigator.

The data model is updated each time new data is entered in the BPA software, improving the algorithm’s efficiency.

BPA’s AI features will radically help organizations solving problems faster and more efficiently, reducing costs and improving customers’ satisfaction.

BPA will progressively introduce AI to suggest risks and actions related to any quality improvement process, like audits, inspections, objectives, indicators, swot analysis, etc.

Conversational intelligence – read article and view video here – and AI features will soon be available with BPA Quality & Risk Management on Office 365.

BPA is proud to be on the front line implementing AI for regulatory compliance.

Applying AI to Regulatory Compliance – Introduction Video

Artificial Intelligence – AI – is a hot topic at the moment. Microsoft has developed technologies for predictive analysis, usually suited for large volume of data. Industry sectors like hospitals start using these technologies for predictive patient treatments. Another aspect of AI is conversational intelligence, also called bots. A bot is a virtual companion that will guide end users achieving their tasks.

BPA’s development lab is working on creating bots to simplify user experience with our regulatory solutions for Quality, Risk and GDPR. A first experimental bot was developed to guide end-users to submit an incident. Using a mobile device, the end-user is prompted to report an incident. The virtual companion asks for important information to be logged in the system, prompts for immediate actions to be done and optionally proposes to append photos to the incident.

Once the incident has been reported, a workflow starts and tasks will be distributed to the concerned users for qualifying and investigating the incident. At the investigation stage, AI is used for optimal root cause selection, based on 5 why and Ishikawa methodologies. AI will further be used for optimal CAPA/Risk management by retrieving relevant historical data in the system and guide concerned persons to solve incidents quicker and more efficiently.

The experimental bot for incident reporting was developed on Microsoft Teams and runs with any mobile device. It will be soon available for our Office 365 customers. BPA is very proud to be on the front line applying AI to regulatory compliance.

BPA GDPR Compliance on Office 365

GDPR Compliance Simplified – App Introduction Video

BPA GDPR Compliance is a preconfigured app to simplify data privacy compliance and reduce the cost to be GDPR compliant. The app is ready to be downloaded from the Microsoft store and installed in your Microsoft Office 365 tenant.

Integrating all needed tools in a preconfigured template, BPA GDPR Compliance simplifies your GDPR journey, facilitates data privacy compliance which will leverage your company image and transparency.

View a short BPA GDPR Compliance introduction video below and ask us for a free trial today.

Benefits of Moving Your BPA Software to the Cloud

Some recent impressive statistics show that 400 000 organizations use SharePoint and 70% of all SharePoint users are in the cloud (Microsoft, May 2018).

Moving to the cloud brings huge benefits and savings for companies of all sectors and sizes.

BPA Cloud Benefits

A Forrester study demonstrated Office 365 delivers an ROI of 321% with a payback period of two months for the composite midsize organizations. The study lists monetary benefits – more than $1M over 3 years – a midsize organization can expect: savings from reduced IT support effort, savings from substituted Microsoft licenses, savings from eliminated hardware, etc.

By transitioning to the cloud, you have additional benefits, like better security and service availability. Moving your software to Office 365 cloud simplifies your process to be GDPR compliant.

Microsoft is adding a bunch of new services to the cloud. With Office 365, you will benefit from more capabilities, like advanced workflow tools and connectors, powerful mobile apps and the most advanced reporting solutions. New technologies for AI and machine learning are now available in the Microsoft cloud.

The last 3 years, BPA has invested a lot of effort to make its solutions available with Office 365 and SharePoint online. The same user experience that makes our solutions unique is now offered in the cloud. Starting today, new apps and features will be developed for our cloud customers in priority, like a GDPR Compliance app, an e-signature module and more to come.

Take this opportunity to move your existing BPA software to the cloud and save even more with our time-limited offering. We offer our customers FREE migration services + a special software discount to move to Office 365. This offer is valid until September 30, 2018.

Contact us to know more about this time-limited offering.

Cost Saving

Calculate Your Cost Savings with a Digital Solution

It’s not easy to deliver engaging, efficient experiences when you’re held back by pen-to-paper-based processes.

A digital solution offers a centralized location where organizations can efficiently store, organize, manage, access, and distribute information.

Cost Saving

For the quality/regulatory department, information typically includes forms (audits, incidents, non-conformances, CAPA, indicators, risks, equipment maintenance, training, etc.) and quality/regulatory documents. By giving collaborators quick and easy access to the information they need anytime and anywhere, digital systems help employees focus more time on their core activities.

What are cost saving opportunities with a digital regulatory compliance solution?

  • Electronic forms enforce collaborators to enter consistent information quickly and easily, reducing errors and manual rework.
  • Automated workflows accelerate the process of creating and distributing forms and documents across devices and platforms.
  • A digital system prevents collaborators to retype data at some point during the process thanks to data relations and automated reporting tools.
  • No paper processing is needed anymore, saving printing, scanning, postage and archiving costs.
  • Users spend a huge amount of time each day searching for information — an average of 37 minutes or 8% of the work day. Digital search tools can reduce search time by up to 50%.

Let’s crunch the numbers to see how much money your organization/department can save with BPA’s solutions.