gdpr

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 https://onshoretech.com

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 https://www.nutsl.com

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 https://www.bpa-solutions.net