Strategy 3 – Risk-based Approach

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There are four opportunities to apply a Risk-Based Approach for Computer Systems Validation.  These opportunities include utilizing risk to scale, supplier audit efforts, validation deliverables, testing and documentation levels. All functions and requirements should be treated with the same risk criteria. This risk criteria establishes the true levels of risk.

Supplier audits are a critical component to the quality of project deliverables, outcomes and lifecycle speed. Many risk-based approaches view all suppliers with the same impact. Supplier audits should follow a risk-based approach that appropriately defines their risk. Some suppliers significantly impact outcomes, while others have a minimal impact. When functional requirements and risk test classifications are established to appropriately establish the true risk, testing costs are reduced and speed is increased. Testing is an area that is often underperformed in high risk systems and overperformed in low risk systems.

The necessary documentation levels vary significantly based on compliance, the size or teams and the amount of organization integration required.  Organizations without a risk-based approach bury their teams in unnecessary and time-consuming documentation efforts. Organizations that establish a risk-based approach optimize their teams and documentation levels.

Before a Risk-based Approach:

  1. All systems/functions requirements are treated with the same risk criteria
  2. Resources are not concentrated in the right areas
  3. Excessive resources and costs are spent on low risk systems
  4. High risk systems and low risk systems are factored equally

After a Risk-based Approach:

  1. A “true” risk-based approach strategy is integrated throughout the entire lifecycle including vendor audits for off-the-shelf enterprise systems
  2. Functional requirements and risk test classification are established
  3. Risk-based approach is established for audits
  4. High level risk assessments are conducted (What is the risk if it fails?)
  5. Resources and costs are not wasted on low risk functions of the system

Most companies utilize traditional risk-based approaches that do not consider the “true” risk of the system. Massive costs and resources are wasted on low risk function systems, while high risk functions that affect quality and cycle time are not adequately addressed. Organizations that establish and appropriately test using a scaled risk-based approach optimize their teams and documentation levels.

To learn more about the proven methods EngiLifeSciences employs to help your organization achieve faster, leaner compliance, read the other parts in our series – Strategies for CSV – Faster, Leaner Compliance.

Strategy 2 – Process Standardization

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A standardized process is a well-defined and structured set of activities built for conception through retirement. Process Standardization creates transparency across the lifecycle framework and enables management control. It establishes the when and how for those following it, coupled with consistency. Process Standardization is a systematic method for identifying, assessing, mitigating, controlling and communicating risk-based factors based upon the intended use of the system.

Many organizations want flexible vs. standardized processes. Often times, the “When” and “How” are removed from the equation. This creates too much flexibility and ambiguity within the processes. The challenge is when this creates inconsistencies in the deliverables and each team is executing the processes differently. If there are high level procedures in place and everyone is interpreting them differently, inconsistencies, delays and rework will occur. Firms waste massive resources, costs and time due to poorly defined requirements, requirement revisions, or lack functional or complete specifications and SOPs.

Process Standardization prevents any ambiguity. When you couple the “When” and “How”, and move to a process standardization vs. a flexibility strategy, inconsistencies in deliverables are removed and speed increases. When teams are trained to utilize the standardized processes, they operate more quickly and systematically, and are more predictable and consistent. The deliverables and outcomes that are associated with the various teams also showcase the same benefits.

Before Process Standardization, the following are commonly seen:

  1. Ad hoc IT project governance with subsequent project shortfalls
  2. Validation testing is the only structured testing process which leaves gaps
  3. Diminished data integrity importance in testing and validation
  4. Adoption of emerging IT architectures and mobile devices for validated systems without formal assessment and testing

After Process Standardization, we can achieve the following results:

  1. Deliverables with predefined templates
  2. Clearly established inputs and outputs
  3. Streamlined and integrated processes, tasks, tools, activities and deliverables
  4. Clear expectations and requirements for the users to follow
  5. Continual improvement capabilities
  6. Uniformity, simplicity and process transparency
  7. Informed IT governance with QA input factoring in validation planning
  8. UAT and validation testing phases with a clear transition
  9. Software Development Best Practices
  10. Management practices with reviews and approvals
  11. Early addressing of data migration and integration requirements and solutions with testing
  12. Proactive assessment of changes in IT architectures and devices by business,
    IT and QA

The EngiLifeSciences team has heard over the years from their clients that they want flexibility vs. process standardization. However, without standardization – especially in large organizations –inconsistencies in deliverables and team execution create inefficiencies and are problematic. We work with your organization and staff to create and utilize standardized processes, allowing you to operate faster, with more predictable and consistent results.

To learn more about the proven methods EngiLifeSciences employs to help your organization achieve faster, leaner compliance, read the other parts in our series – Strategies for CSV – Faster, Leaner Compliance.

Strategy 1 – Well-defined Lifecycle Framework

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A well-defined Lifecycle Framework strategy is designed to create a uniform approach throughout the entire organization.  The benefit of having a uniform approach reduces the amount of rework that will occur during every project execution. The better defined the Lifecycle Framework becomes the less rework occurs in defining the same processes over and over.  When an organization has procedural requirements that are interpreted differently, ambiguity is created. This is often seen in organizations that have high level procedures. Significant time is spent in every program and project where the wheel is reinvented every time. This alone can add an additional 5-10% overhead.

It is critical to define and integrate all activities and deliverables. As the activities progress throughout the lifecycle, it is key to integrate the validation activities throughout this framework. Often times, development and validation teams are in silos (vs. integrated), which creates rework in order to be compliant. Teams cannot deliver the appropriate deliverable if the framework is not well defined. When a process is well-defined, and everyone is trained, the execution goes much smoother and faster, significantly reducing cycle time.

Lifecycle Framework establishes specific activity requirements to be followed. It is often not clear when or how a specific deliverable needs to be developed. There is time wasted during the handoffs within the team due to it not being well understood by the entire program.  Too often than not, it takes double the resources to rework everything because specific activity requirements are not well-defined. This puts the project at risk.

The Lifecycle Framework strategies can be commonly referred to as the V Model, Waterfall, Agile, Iterative and others. The goal is to build a well-defined and integrated framework that drives the Who, When and How. This establishes a cost-effective framework. The challenge is that most organizations lack a well-defined and integrated framework due to lack of lifecycle maturity.

Before Lifecycle Framework

  1. Activities and tasks are not well organized and create inefficiencies
  2. Processes are not executed properly and negatively impact deliverables
  3. The How, When and Where are not clearly defined and causes cycle
    time delays
  4. Handoff of deliverables are not clearly understood by the team
  5. Post deployment defects occur

After Lifecycle Framework

  1. Key inputs and outputs from each phase are clearly defined
  2. Defects are removed as early as possible
  3. Systematic structure organizes the activities, which allows for cost-efficient, effective and high quality process output
  4. The Who, When and How are defined and provide clarity, transparency and repeatable processes

A w­­­ell-defined Lifecycle Framework ensures efficient and constant outcomes. To learn more about the proven methods EngiLifeSciences employs to help your organization achieve faster, leaner compliance, read the other parts in our series – Strategies for CSV – Faster, Leaner Compliance.

Avoiding Challenges with any Computer System Validation (CSV) and Global Validation Governance Process

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The pharmaceutical and medical device industry is a rapidly changing environment. Successful businesses are those who are able to stay on top of the newest trends and regulations while aligning their costs and compliance. In these highly regulated industries, it is imperative to utilize Computer System Validation (CSV) to ensure the quality and accuracy of data.

Some of the issues that are important to avoid in utilizing a CSV system may include costly compliance issues and remediation efforts, deployment delays and failures, rework, increased cycle time, post deployment defects and data integrity issues, team integration issues, and technology adoption avoidance.

One of the common problems we have found in organizations is that the global validation governance process is rooted in a decentralized state. When the organization for SQA, Leads and Managers are structured within different reporting structures, it can require staff to follow and train on multiple processes depending on the business unit. This increases the risk and difficulty of improving or managing business processes. Spreading the responsibilities across an organization requires more overhead and incurs more risk because of the effort required in planning any determined course and the inconsistencies it may encounter.

A centralized CSV and Global Validation Governance process expands the capabilities of the organization. CSV resources are assembled within the same reporting structure which defines a single process across the entire organization allowing a systematic, consistent approach that mitigates risk.

EngiLifeSciences has found and industry tested a successful lineup of strategies that ensure the following essential pieces to any CSV program:

  1. Faster, leaner, effective compliance
  2. Faster deployment
  3. Elimination of non-value added activities
  4. Reduced cycle time
  5. Defect removal early in the lifecycle and data integrity
  6. A well-defined lifecycle and training
  7. Elimination of paper-based processes and technology adoption that drives efficiency

With expertise and experience, we have developed unique strategies to help organizations prevent these and other frequently expensive hurdles.

Learn more about CSV and why it is important here: https://www.engilifesciences.com/why-computer-system-validation-csv/

Navigating the Regulatory Landscape

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The regulatory landscape is dynamic in nature, constantly evolving and changing at an accelerated pace. Keeping up with the changing regulations can be an uphill task for organizations in highly controlled industries. EngiLifeSciences is committed to unraveling the complexity of regulatory compliance in the life sciences industry.

Our mission is to help enterprises bring high-quality, compliant products to the market using their cutting-edge compliance and managed consulting solutions. We provide consultation services to the medical device, pharmaceutical, and biotechnology industry. EngiLifeScience’s consulting expertise encompasses software compliance, software technology, computer system validation, quality systems, and quality and business performance characteristics. We offer an array of services that are targeted at increasing the bottom line of an organization.

In the quality systems area, we help with process improvement including compliance. Addressing the regulatory concerns and issues, we assist our clients in transforming their processes to a compliant state and also help in remediation of various areas of the quality systems. When it comes to quality and business performance, we focus on product development, manufacturing, information technology, quality systems, and how these processes can integrate together to offer end-to-end visibility, helping organizations identify opportunities. This visibility enables organizations to pinpoint their internal challenges and confront them immediately instead of dealing with them later unprepared.

For compliance challenges and regulatory changes that occur in the life sciences industry, EngiLifeSciences has devised the MEV Grid™ which stands for maturity, efficiency, and visibility. The grid embeds end-to-end visibility, maturing processes, and efficiency within the processes and technologies in an organization. We have also developed a 3PO Model™ that can help our clients identify opportunities, which can impact the bottom line within the first year we do the assessment. EngiLifeSciences 3PO Model helps in driving operational efficiency so that when industry changes occur, there is a lower implementation cost and higher efficiency and execution.

One of our main objectives is to be a transformational agent in the life sciences industry, bringing more innovative approaches to organizations and impacting their internal processes so that they are more adaptable to the external changes occurring in the industry. We help organizations keep pace with the rapidly changing regulatory ecosystem and become more agile so that they can attune faster to the external conditions in the market.

What does the EngiLifeSciences process look like?

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At EngiLifeSciences, we begin with an assessment process, and a part of the process is helping clients understand their strategic objectives. Following that, we conduct tailored studies at different levels in an organization, all the way from management, performance management area, to the training of company personnel. We also assess the vitality of the organization’s structure and the supporting business requirements and analyze these studies to help CEOs identify opportunities that they are not aware of. This can be eye-opening for company executives. Today, CEOs in the diverse industries are challenged with the lack of end-to-end visibility, and they often strive to enhance operational efficiency while increasing agility. These studies help discern the gaps that may lie within the organization and meet the aforementioned objectives. We also aid organizations in determining if they are in-cognizant of any internal regulatory compliance risks.

Using our MEV Grid™ which stands for maturity, efficiency, and visibility, we can assess end-to-end visibility, maturing processes, and efficiency within the processes and technologies in an organization. We have also developed a 3PO Model™ that can help our clients identify opportunities that impact the bottom line. Our 3PO Model supports driving operational efficiency so that when industry changes occur, there is a lower implementation cost and higher efficiency and execution. When it comes to quality and business performance, we focus on product development, manufacturing, information technology, quality systems, and how these processes can integrate together. This visibility enables organizations to pinpoint their internal challenges and confront them immediately instead of dealing with them later unprepared.

With one of our clients, EngiLifeSciences had undertaken an optimization project for one of the largest medical device manufacturers, a global enterprise that was looking to reduce the overhead in their computerized system validation process. We collaborated with the organization, interviewed 27 teams across the organization and helped them streamline and standardize some of their processes. Within a small window of time, EngiLifeSciences was able to reduce the client’s overall operational cost by 20-30 percent, the identified saving being more than 25 percent.

Using our cutting-edge compliance and managed consulting solutions, EngiLifeSciences is helping companies in the life sciences bring high-quality, compliant products to the market.

Why Computer System Validation (CSV)?

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Computer system validation (CSV) has become essential in the drug and medical device industry. The FDA defines process validation as “establishing documented evidence which
provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.”(1) Validation requires evidence that a process is clear, repeatable and will stand up to audits. CSV is able to generate documented evidence that every part involved in the manufacturing process will work correctly every time.

CSV requires a comprehensive plan. The creator of such a plan should understand the regulatory environment as well as the scope of the business process. Some key components of any validation plan are:

  1. A risk assessment
  2. A complete, systematic plan detailing the project and who and what is required to complete it
  3. Detailed steps to be taken to provide the evidence necessary to validate the system
  4. A plan for testing each segment of the project
  5. Test cases to determine test results
  6. A summary of the validation plan
  7. A roadmap for procedures after validation has been completed

There are four critical areas that impact and drive the cost of change: People, Process, Performance Management and Organization. The right CSV program ensures these critical areas
are aligned and optimized, allowing industry change and conformance to new regulations to be implemented at a lower cost and with higher efficiency. Success in the industry is dependent on the ability to operate with quality, efficiency and compliance.

(1) https://www.complianceonline.com/dictionary/computer_system_validation.html

Gregory W. Pierce: Revolutionizing the Healthcare Industry

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Gregory W. Pierce, the CEO of EngiLifeSciences, has been a frontrunner in developing solutions that allow Medical Device, Pharmaceutical and Biotechnology Manufacturers to efficiently bring compliant and high-quality products to market. Gregory’s career started in the United States Air Force working within the military hospitals as a Medical Laboratory Technologist and then transitioned to working in Research and Development for a major Medical Device Manufacturer; in the development of technology which falls in the category of Digital Health, and later in working for corporate America in the development of new technology medical products. “The pivotal point for me was when I decided to start my own company helping companies in the medical device, pharmaceutical and Biotechnology industry,” states Gregory.

During his 28 years of experience, Gregory has worked with many high-profile companies. He avidly participates on industry initiatives and collaborations within the healthcare industry. EngiLifeSciences is a consulting firm that provides services across the healthcare value chain. The company’s consulting solutions include Quality Systems, Product Development, Manufacturing, Information Technology, Regulatory Compliance, Software Compliance, Software Technology, Computer Systems Validation, and Quality & Business Performance. It offers an array of services that are targeted at increasing the bottom line for an organization. One of the visions of EngiLifeSciences is to be a transformational agent in the life sciences industry, bringing more innovative approaches to organizations and impacting the internal processes. It helps organizations to keep pace with the rapidly changing regulatory ecosystem and become more agile so as to attune faster to the external conditions in the market. Gregory comments, “Allowing ‘common sense’ practices to drive our behavior and involving the organization in that change, develops a culture of ownership and accountability which opens the door to innovation and increased visibility.”

According to Gregory, technology and digital health is expanding at an accelerated rate, including the use of artificial intelligence and other technology solutions to bring value to the health care. “For us to be an accelerator in the health care value chain, bringing more innovative approaches to organizations, and impacting internal processes resulting in agility and innovation is necessary.”

Artificial Intelligence and How it is Changing the Medical Device Landscape – Part 2 Applications

By | Anything, Blog

Artificial Intelligence (AI) has a multitude of applications within the medical field and in particular, with medical devices. As the purpose of AI in any field is to augment human aptitudes and experiences, the expanded capabilities provided in the medical field are vast. Four areas seeing expansion of AI are in management of chronic diseases, surgical robotics, medical imaging, and the partnership between AI and Internet of Things (IoT).

In the management of chronic diseases, often the physician or other healthcare professional sees merely a snapshot of the patient’s health profile. AI provides a way to continually compile data through wearable devices, portable medical devices, and other monitoring technologies. That data can then be analyzed and translated into information that a patient can use. In some current applications, AI is able to predict potential problems and provide a solution.

AI combined with machine learning is being explored in the surgical field for purposes such as automation of suturing, evaluation of surgical skills, improvement of surgical robotic materials and surgical workflow modeling. Although these are not all being used currently in real world application, they are continually being tested and developed to improve the surgical landscape.1

Medical imaging requires the assessment of large amounts of data to determine an accurate diagnosis. Algorithms are created to recognize anomalies that could otherwise be missed by the human eye. This more detailed processing supports a quicker, more accurate result.2

Combining AI with IoT expands the possibilities of medical devices. IoT allows the data collected from wearable gadgets or portable devices to be collected and analyzed remotely. Merging this collected information with other relevant databases provides a more comprehensive view.3

With all the potential applications of AI in the medical device field, compliance with regulatory policies and processes is vital. Read more about how AI is stimulating change in regulatory environment in Part 1.

 

(1) Machine Learning in Surgical Robotics. www.techemergence.com. Retrieved 2018-04-15

(2) AI Medical Devices. www.techemergence.com. Retrieved 2018-04-15

(3) The Impact of Artificial Intelligence. www.mpo-mag.com. Retrieved 2018-04-15

Artificial Intelligence and How it is Changing the Medical Device Landscape – Part 1 Regulatory Changes

By | Anything, Blog

The Food and Drug Administration (FDA) defines Artificial Intelligence (AI) within the Digital Health Criteria as “A device or product that can imitate intelligent behavior or mimics human learning and reasoning. Artificial intelligence includes machine learning, neural networks, and natural language processing. Some terms used to describe artificial intelligence include: computer-aided detection/diagnosis, statistical learning, deep learning, or smart algorithms.” (1)

AI itself isn’t new, but the increasing applications in the medical field have inspired the recently released the “Digital Health Innovation Plan” to address the balance between fostering digital health innovation while ensuring the safety of potential patients. This plan is designed to reshape the policies and processes used, modernize the tools used by the FDA to match digital health technology needs, and provide the clarity needed by manufacturers and developers to ensure they comply with policies and processes.(2) Additionally, modifications are being made within the National Evaluation System for health Technology (NEST) to provide a collaborative system that links and processes information between medical devices, electronic health records, clinical registries, and medical billing claims. This system will provide a more complete collection of data to enable healthcare providers and patients to make informed treatment decisions. (3)

“As AI undergoes major shifts, it reshapes our world, as well as our human experience, and as a result our understanding of AI is being challenged every single day. As it stands, AI should be used as an extension of humans, and implemented so as to foster contextually personalized symbiotic human-AI experiences. In other words, AI should be developed in a manner that is complementary to humans, whether it’s designed with the intent to assist or substitute. And, contrary to popular belief, AI isn’t designed to replace humans at all, but rather to replace the menial tasks performed by humans. As a result, our AI-powered society will open the door to new jobs and career paths, allowing man to unlock greater possibilities and reach new developmental heights. In short, AI will augment our human experience.”  Charles-Antoine Richard, DZONE Zone Leader and Marketing Director, ARCBEES (4)

The potential applications of AI in medical devices are vast. These innovative technologies are compelling a change in the way advancements are regulated. The challenge remains in the ability for developers to advance the future of AI while complying with the necessary shifts in policies and procedures.

 

(1) Digital Health Criteria. FDA.gov. Retrieved 2018-04-11
(2) Digital Health Innovation Action Plan. FDA.gov Retrieved 2018-04-14
(3) National Evaluation System for Health Technology (NEST), FDA.gov. Retrieved 2018-04-12
(4) DZONE’s Guide to Artificial Intelligence: Machine Learning & Predictive Analytics. DZONE.COM/GUIDES