Measurable Benefits of Using BPA’s Quality Software

Quality is what businesses can ultimately use to differentiate themselves from their competitors. It’s what keep customers loyal and satisfied. A quality management system eliminates defects, ensuring you’re consistently creating quality products and services that meet expectations.

The QMS market is growing promisingly at a double-digit rate. Recent studies demonstrate CEO’s top concerns is regulation and compliance; CEO’s investments in risk and compliance will increase the next 3 years; US companies will invest millions on GDPR readiness (PWC, Accenture, 2018).

BPA’s mission is to develop regulatory platform & software solutions – Quality, Risk, GDPR – with maximal user experience, to improve organizations’ processes, products, services and simplify regulatory compliance.

BPA’s software is unique because it’s powered by the leading collaborative Microsoft Office 365/SharePoint technologies and fueled by the most flexible no-code app building platform. What makes our software unique also brings unique measurable benefits to our clients:

TopicPainsGains with BPA
Customer satisfaction
  • Number of complaints
  • Time to treat complaints
  • Recurring complaints
  • Reduce number of complaints by detecting issues earlier
  • Reduce time to treat customer requests and integrate customers in automated flows
  • Increase customer satisfaction, win loyal customers (meet client expectations, eliminate defects early, etc.)
Cost of non-quality
  • Cost of not managing risks
  • Cost of non-conformances
  • Supplier non-quality
  • Cost of losing customers
  • Cost of downtime in production
  • Poor image, reputation
  • Cost of waste…
  • Higher fines (GDPR, environment, health, quality, security…)
  • Save cost by reducing number of errors and manage risks effectively, avoid problems occur again
  • Integrate clients/suppliers in the system and improve the end-to-end supply chain
  • Detect problems earlier (audits, risks, indicators, etc.)
  • Engage collaborators in the QMS, develop a proactive attitude
  • Increase revenues through better products, services loved by customers
  • Get a unique solution for global-compliance (GDPR-Quality-Risk)
Continuous improvement
  • Employees responsibility no clearly established
  • Insufficient employee skills and training
  • Poor collaborator engagement, low motivation
  • Disconnected processes with poor interactions
  • Centralized QMS with poor employee engagement
  • No competition differentiation
  • Rigid, non-flexible QMS software
  • Establish clear employee responsibilities, train collaborators, decentralize QMS, reduce operator errors
  • Link all improvement processes together and engage process owners
  • Differentiate through quality of your products, services
  • Get full control on your QMS template using no-code “Lego” bricks and let the software adapt to your processes on the long-term.
Process efficiency
  • Heavy cumbersome paper systems, form/paper processing
  • Rekeying data in many files
  • No real-time reporting
  • Automate, optimize and standardize processes (e.g. reducing time to handle incidents by 50% and more)
  • Reduce number of paper documents
  • Reduce time to process forms/documents
  • Reducing time to search for information
  • Faster decision making
  • Powerful BI reports

>> Calculate savings with our cost saving calculator

  • ISO 9001, 14001, 13485, 16949, 27001, etc.
  • FDA, EU regulations
  • GDPR, data privacy regulations
  • Internal Control Systems (COSO)
Simplify regulatory compliance and meet regulations with one solution for global compliance
  • Siloed departments with lack of communication
  • Cumbersome paper systems, lots of Excel files, etc.
  • Poor access to QMS
  • Share and work together, seamless collaboration, instant discussions
  • Better connect with external customers and suppliers
  • Automate processes, get automated alerts and reminders
  • Connect with other tools, web services
  • Works on any device, anywhere
  • Improve compliance & security

>> Get more done with Office 365



BPA Selected by Microsoft in the SharePoint Business Apps Partner Program

We have exciting news to share: BPA Solutions has been selected in the Microsoft SharePoint Business Applications Partner program.

On January 24, Microsoft announced the latest additions to their Business Apps Partner Program and BPA Solutions was accepted as new Charter Member.

Selected companies have been recognized for proven customer success as Microsoft Preferred.

Our success story with Saving Sight – a nonprofit organization that changes lives through the gift of sight – was listed on Microsoft Tech Community. (read it here).

We are very thrilled to have been selected by Microsoft in this program. Microsoft has recognized BPA’s involvement in helping our clients to implement applications – Quality, Risk, GDPR – to simplify regulatory compliance and give a maximal user experience through Office 365 technologies.

Microsoft recognized BPA for our success in creating and supporting business apps in Microsoft 365 using SharePoint, PowerApps, Microsoft Flow, Microsoft Forms, Power BI and more.

Among benefits of this program, BPA will access Microsoft product roadmap details, crafting ever-better solutions for our customers.

Access the Microsoft SharePoint Business Apps Partner Page

BPA Announces Partnership with Dubai-based Inforbit

Seasoned industry veteran Nilesh Jain announced today that he has partnered his Inforbit Solutions, an IT company based in Dubai, with BPA Solutions Switzerland to offer its unique solutions on top of Microsoft Office 365 and SharePoint.

Through this strategic partnership, Inforbit will help clients in the Middle East region to have easy & fast to build / deploy solutions with no code on top of Microsoft SharePoint. Clients will benefit using BPA Solutions software and Inforbit experience of the industry and IT knowledge to further reduce the cost of ownership.  Clients across Middle East using Microsoft SharePoint can now take advantage of the ease and simplicity of the software with the most powerful and elegant tools including mobile applications.

“I am excited to partner with BPA Solutions for the Middle East market,” said Nilesh Jain, CEO of Inforbit Solutions. “It’s clear that businesses are now moving towards cloud adoption and BPA Solutions unique offering along-with Microsoft best in class Office 365 solutions provide new affordable alternative so that companies can focus on their core competences rather than complex IT solutions. With BPA Solutions softwares, we’re putting the power in the hands of users Inforbit has proven best expertise in local market needs and can provide first-class, technical support and customer success service”.

“I believe that through our partnership with Inforbit Solutions we will help Middle-East-based businesses getting the benefit out of their investment in Microsoft solutions” said Boris Lutz, co-founder and CEO of BPA Solutions. BPA Solutions best in industry application builder for SharePoint and Inforbit’s marketing and customer support expertise make our partnership a clear win-win,” said Boris.

About Inforbit Solutions

Inforbit Solutions is a new entrant in the market but being guided by the industry & market veteran who has helped many companies in the region with their ERP, CRM, HRM, Document Management, Workflow Management, Business Process Management etc. Inforbit provides in-depth consultancy around Microsoft Office 365 and SharePoint solutions. We follow a tailored approach to help you plan, design, deploy, customize and operate your enterprise’ investment proficiently. Founder has delivered multiple large & small projects successfully and helping businesses achieve integrated capabilities, increasing IT productivity and lowering cost.

To learn more about Inforbit Solutions, please 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

Global Data Compliance in 2019

Written by Mark Adams, David Kruger – iComply365, BPA’s strategic GDPR Partner.

GDPR’s operational launch in 2018 has put into motion a global tide that will change the management of personal and sensitive data forever.  Sensitive data for the purposes of this discussion is anything that that presents risks to data holders, whether private concerns or government agencies. GDPR has presented a case, not just to the EU but to the world that data can and should be properly managed. Time will tell how easy this will be or how well it will be policed, but the concepts embodied in the GDPR change expectations in a way we believe will have a lasting effect on global commerce, politics, economics and ethics.

The major trends we see developing this year include:

1. Compliance and Regulation Landscape

A quick look back and forward, with a focus on topics and trends that will drive the shape of compliance, the compliance market and the growth of RegTech.

1.1 GDPR will underpin similar global privacy frameworks

Most of the EU has made a good start to adopting GDPR, compliance measures to the standard will be tested at all levels in 2019, with fines and actions intended to show both carrot and stick.  Actions taken by regulators (like Frances £44m fine on google this month) and commercial class actions (driven by public sentiment) against global tech giants like Google and Facebook and others will ripple through all markets, increasing pressure for all to manage data in a consistent and provable manner.

Much work is still needed to refine what global adequacy might look like, including the launch of the related e-Privacy Regulation, but the core principles will quickly become sufficiently refined to spawn new regulations and standards.

To facilitate this, the tech world needs to develop broad, scalable solutions and services that allow compliance to be operationalised and affordable for organisations of all sizes.

Aligning regulations currently include California’s CCPA and Brazil’s LGBD, Japan, South Korea, Mexico, other US states and the US federal government, Canada, New Zealand and portions of Asia and Africa are considering broad reaching privacy regulations.  Tech giants such as Microsoft are working to get ahead of the curve by influencing standards, implementing more compliance-enabling privacy and security controls into their products.

Smart organisations should leverage their GDPR process investments to ease their compliance with these global initiatives and so gain commercial advantage.

1.2 Brexit Effect

With all the talk surrounding Brexit and the various scenarios that could happen, it is useful to look at the potential effect on data transfer and what that might mean for organisations and their IT systems.  This article from Tim Hyman on Brexit is quite instructive – Data protection and your IT Systems.

Elizabeth Denham, the UK Data Commissioner, state in December: “the Government has already made clear its intention to permit data to flow from the UK to EEA countries. But transfers of personal information from the EEA to the UK will be affected.” Here’s a link to the ICO’s recently published guidance about Brexit and what it means for data protection compliance.

1.3 From Compliance to a Culture of Care

Data is now a risk as well as an opportunity. This requires a shift in mindset for organisations.  For the data protection officer, simply implementing better data protection and management may not be enough. In the 21st century, success will increasingly depend not on mere compliance, but developing a genuine sense of stewardship for the personal data under their care.

1.4 State and politically motivated attacks

State-influenced cyber attacks on organisations, journalists, dissidents, voting systems and politicians will continue to grow. All nation states attempt to steer the voting patterns of both their allies and their enemies—and they always have.

A worrying and growing trend is states monitoring their own citizens for political purposes as played out in the case of Saudi journalist Jamal Khashoggi. Indeed, some technology firms appear to be focusing on exporting surveillance technology purpose-built to aide governments in spying on their own citizens. There is little doubt there will be more calls for this behaviour to be regulated. The surveillance state and privacy proponents have always clashed, but the fight is likely to be noisier and more public than in the past.

1.5 Nations will “try” to establish cyber warfare rules

Even in physical warfare, most nations have agreed upon a basic set of rules, such as the Geneva convention.  Some nations are acting as they can do almost anything with impunity. “Digital borders” are being tested and tensions are rising. Expect more calls for a “negotiated peace” in the form of treaties designed to reign in digital warfare.

The situation will continue to get worse unless global geopolitics starts to take this seriously.

1.6 Compliance and the Supply chain

Organisations are increasingly integrated into their supply chain, associates, suppliers, client portals, external IT service providers and more. A large proportion of breaches occur due to weakness in the supply chain. Whilst privacy legislation processes, supplier contracts, and advances in encryption and other security solutions are making incremental improvements, this area remains high risk and needs more attention.

1.7 Ethics

Data ethics emerged in 2018 is a priority for many leading organisations, stung by security breaches and that then reflected to be breaches of public trust.  2018 was in some ways the year where data mishandling, and trust hit rock bottom and now organisations must rebuild trust.

2019 should see organisations step up efforts to ensure ethical data use and ethical data practices.   Forbes suggest that demand for corporate data ethics and greater data responsibility is increasing.  Data ethics is not just good citizenship, it’s a good business practice.  It looks like organisations will add new roles and governance approaches to address this issue over the next year.

1.8 DPOs/CSOs/CISOs—Do they have the skills?

Cyber security and data management training will continue to mature, as a new generation of degrees and certifications are developed to bridge the current skill gap. Many of these will be post-graduate courses designed for senior professionals needing to augment their existing knowledge. “Master’s” degrees in data management and cyber security” will start to be mainstream with more and more companies looking to hire DPO’s/CSOs/CISOs with cross-disciplinary skills.

This means a complicated job will continues to get more so. Technology providers will need to step up to keep workloads down.

2. Operationalising Compliance

Central to our own business strategy is how do we leverage both compliance and IT know how to help operationalise compliance and data management.  It needs to be made as agile, efficient, transparent and as cost effective as possible.  The section below touches on technologies and topics we believe will contribute to the success of these goals.

2.1 Complexity and economies of scale is driving operationalisation

Technology researchers at Gartner, Inc. have noted that security detection and response, rather than just preventative measures is a now a top priority for organisations. With a worldwide shortage of nearly one million security professionals, we must automate routine processes to amplify the impact of trained human beings. Gartner predicts that by 2021, security and privacy automation will be high on the list for organisations.

2.2 Cloud Computing

The cloud continued its march toward domination in 2018. Two Deloitte surveys, for example, indicated that 90% or more of global executives are adopting, considering, or already using the cloud. Amazon Web Services, Microsoft Azure, and Google Cloud are all growing rapidly.

They are increasingly adding software and data management capabilities to their clouds, including enterprise data warehouses, DevSecOps, DataOps, advanced analytics, various forms of AI, Internet of Things, blockchain and robotics applications.

Security and Compliance as a Service will start to mature from vendors like Microsoft, whose Advanced Threat Protection (ATP), Azure Information Protection (AIP), Compliance Manager are designed to operationalise compliant working. These facilities example how CSP can help organisations to intelligently assess their compliance risks, to govern and protect sensitive data and provide data lifecycle management to effectively respond to changing and overlapping regulatory requirements.  Check out this 2-minute video.

Many organisations are adopting a shared risk, cloud-only model for information management as the most sensible way to balance capability, agility, risks and benefits, and the expenditure of time and money.  

2.3 Cybersecurity

McAfee Lab’s Threats Report suggests that malware exploiting software vulnerabilities grew by 151% in the second quarter of 2018. The volume of these attempts leads us to believe that the only way to address them is by using AI/machine learning for cyber-threat intelligence, detection, and resolution.  The question is whether the good guys or the bad guys master AI first.

Though far from a perfect solution, most websites and online services will abandon password-only access and offer additional required or optional authentication methods. For a while, the different forms of multi-factor authentication will likely confuse and frustrate users. Ultimately authentication will be hardened and mandated globally for all online transactions to provide the level of trust needed for eCommerce to continue and grow.

Like malware, spear phishing becomes even more targeted, Attackers know that the more data they have about you, the more likely a phishing campaign against you will succeed. AI in the hands of bad actors will further undermine traditional trust-based financial transactions by using detailed knowledge of prior transactions to dupe users.

Insecure email needs to be replaced by more secure communication for high risk transactions.  

2.4 AI impacts – Blending, People, Process and Automation

From an operational perspective, cloud services are investing heavily in artificial intelligence and machine learning, as they look to support and complement “the humans” who ultimately run organisations.   We see increasing numbers of organisations adopting a growing range of AI technologies to optimise the respective capabilities of humans and machines.

It’s a case of marrying use cases with the most appropriate AI technology solution in a manner that enables humans to stay in control whilst reducing risk.

2.5 DataOps

Data Operations (DataOps & DevSecOpps) is rapidly emerging in organisations that must manage data as a shared business asset.  A core goal of GDPR is to implement Privacy-by-Design as such these methods need to be more widely adopted.  DataOps brings engineering principles borrowed from the DevSecOps software development movement.  The intent is DataOps is to deliver “rapid, comprehensive, and curated data” to business analysts and decision-makers.  Forbes expect 2019 to be a breakthrough year for DataOps as organisations strive derive value quickly and efficiently from their data assets, but with less risk.

Encryption is now available in so many forms, that organisations can no longer justify breaches or operate insecure solutions due to implementation or cost constraints. 

We will shortly be providing more guidance on Encryption strategies. 

2.6 Managed Compliance Services

A recent report suggests that the compliance-related managed services market is likely to grow as much as 25% Compound Annual Growth Rate (CAGR) in the US over the next 4-5 years.  We believe growth in other regions will be similar as the commercial consequence for none-compliance ripple outwards.

Managed Compliance Services include: data management, data discovery and mapping, data governance, API Management, GDPR readiness assessment, data subject risks assessment and DPIA, DPO-as-a-Service, and GDPR-related training and certification.

Check out our Microsoft cloud compliance services

2.7 Compliance Apps and Solutions

Just like Compliance Managed Services, specific compliance solutions will be needed in one form or another to simplify and operationalise local compliance activities.  Very few organisations will want to re-invent the wheel by developing solutions from scratch if they can lower compliance lifecycle costs by using off-the-shelf solutions that fit their needs, work well and are reasonably priced.

We can find little specific data on this segment but given the number of vendors entering the market and the depth and breadth of solutions on offer, the market is significant and vendors that gain market share quickly should benefit geographically as compliance goes mainstream.

Solutions cover a wide gamut: endpoint security, legal, risk and compliance solutions, consent management, specific encryption solutions, enhanced authentication products and services, network security products and strategies, security analytics, intelligence, response and orchestration, secure storage and general security products.

Checkout our Office 365 BPA Solutions GDPR platform

2.8 Blockchain

2018 represented a year of major advancement in the use of blockchain technology to enable identity and supply chain trust.  Finance, asset management, and healthcare are taking the lead in adopting blockchain. Increasingly rapid development and adoption of blockchain technology bodes well for personal data protection, but some work is needed to blend this with other technologies and apply it to mainstream use cases.

BPA Announces iComply365 as Strategic Partner for GDPR Compliance

BPA is proud to announce a new partnership with iComply365 a UK/US company that specialises in cloud enabled Compliant Working solutions.

iComply365 were instrumental in the design of our new BPA GDPR solution, providing subject matter expertise that enabled us to develop and bring to market this comprehensive compliance solution.  BPA GDPR simplifies every element of GDPR lifecycle management from initial process capture to operational management through demonstrating compliance to management and regulators.

Like our other solutions, BPA GDPR is built as a native Office 365 app. It benefits from deep integration with all of Office 365 capabilities such as workflow and dashboards.  BPA GDPR also integrates with Microsoft’s cloud compliance features, adding additional value and operational simplicity for clients.

GDPR and wider data compliance requirements are complex. As compliance and as Microsoft Office 365 and cloud experts, iComply365 is available to support you throughout the buying and implementation process, enabling a deployment that is tailored to your specific needs.  From a compliance perspective, they can also provide starter content packs and other compliance-orientated solutions and services ranging from quick add-ins to fully manged compliance services.

Both companies are excited because BPA GDPR global availability via Office 365, positions us well to deliver this solution to clients worldwide as data compliance regulations are becoming increasingly ubiquitous.

Comment from management teams:

« I’ve known BPA Solutions for years because of my own Microsoft channel background.  When I saw the commercial opportunity to for a Microsoft Cloud based GDPR solution and refined the solution specification, BPA Solutions Office 365 platform was the only solution capable of delivering it. Add to this their existing credibility and client base in the RegTech space, our partnership was a no-brainer ».
Mark Adams – CEO – iComply365

« Working jointly with iComply365 to deliver a great Office 365 GDPR app was the best choice we could make. iComply365 delivered the needed GDPR knowledge and experience to build the app. Using BPA App Builder, we could rapidly configure BPA GDPR with no code ».
Dr. Boris Lutz – CEO – BPA Solutions

Office 365 CRM Software

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

Discover why our CRM software on Office 365 is the perfect CRM for small and mid-sized businesses.

BPA CRM is an out-of-the-box solution, it’s easy to use, efficient and cost-effective. The software is natively built on Office 365 & SharePoint. It is ready to be installed in your Office 365 tenant.

The app brings a unique user experience, because all important tools used by sales persons are in one single interface, like emails, reminders, calendar, telephony, instant discussions, collaborative team sites and more. Power users can easily create powerful mobile apps, workflows and advanced reports with no development needed.

The software is built on the top of our no-code app building platform. Non-IT persons can adapt or extend it very quickly.

Ask us for a free discovery access today.

Office 365 App Builder by BPA: Build No-Code Apps in Hours

What are possible scenarios when developing no-code apps for your most pressing business challenges?

Discover how to build a professional HR recruiting app in 2 days using BPA App Builder.

Most companies still use Excel spreadsheets for storing business data, like incidents, actions, risks, measures, controls, etc. While Excel is very good at advanced calculations and pivot charts, it’s really not suited for effective collaborative work and automated tasks.

Since Access Web Apps have been retired by Microsoft, SharePoint lists is the best way to manage business processes. SharePoint and Office 365 technologies include all tools needed for the modern workspace experience, like emails, calendar, reminders, workflows, mobility, office tools and more. Most of Office 365 plans include SharePoint (Office Essentials starts at 5 USD/user/month).

The BPA App Builder platform includes tools to replace InfoPath, like an intelligent form building solution and tabs to display relational data. BPA App Builder brings unequaled user experience when using SharePoint. It provides intuitive navigation, prefilled data-entry forms, productivity tools, and displays contextual data and documents by topic.

Ask us for a free discovery access today.

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


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.