How Technology Continues to Revolutionize Auditing:The Latest Tools and Their Impact on the Profession presentation for the Association of Healthcare Internal Auditors in 2012
6 Tools for Improving IT Operations in ICS EnvironmentsEnergySec
Presented by: Jacob Kitchel, Industrial Defender
Abstract: This presentation will review useful concepts and tools that can be applied by DevOps team with “Controlled Remediation”. We’ll demonstrate the application of non-security, system administration, deployment, monitoring and change tracking using tools to achieve controlled remediation. This will build a foundation through which security, compliance, and change management goals can be achieved in an automated fashion within control system environments.
DevOps is a juxtaposition of the words “development” and “operations” and is meant to portray a tight relationship between the two traditionally separate roles which build and operate complex computer systems and software applications. DevOps groups work with a unified goal to rapidly and reliably deploy and manage the underlying systems which organizations rely upon to make a profit while balancing resource constraints.
“Controlled Remediation” is a concept used to describe the use of automation to maintain acceptable configuration and settings on industrial cyber assets. Additionally, this presentation will discuss the variations of “Automated Remediation” and “Manual Remediation”.
Cornerstone’s July 29th webinar with Educe Group entitled “Fearing the Cloud: Why the Life Sciences Shouldn’t Fret,” focused on compliance in the cloud in Life Sciences. As with any software utilized within the Biotech and Pharma industry, it is important to understand the overall business intended use and the regulatory and compliance components that drive the overall validation and implementation efforts. This includes a risk-based approach to validation based on the criticality of the business intended use. As with any software, it is very important to understand what the software development process is and how the software is deployed. This is especially true of Cloud-based service models (e.g., IaaS, PaaS, SaaS). This session will focused on the these service models and more importantly considerations for how they should be managed within the Life Sciences industry.
The medical device industry is facing unprecedented challenges due to emerging technologies and increased regulatory scrutiny.
Current “waterfall” product development methods are ill-suited to dealing with the pace of change and uncertainty that product development organizations are facing. This eBook addresses:
* The shortcomings of waterfall development specifically in regulatory environments.
* How agile development meets the safety, reliability and regulatory needs of the medical device and diagnostics industry.
* How agile development can help ensure delivery of successful software.
How Technology Continues to Revolutionize Auditing:The Latest Tools and Their Impact on the Profession presentation for the Association of Healthcare Internal Auditors in 2012
6 Tools for Improving IT Operations in ICS EnvironmentsEnergySec
Presented by: Jacob Kitchel, Industrial Defender
Abstract: This presentation will review useful concepts and tools that can be applied by DevOps team with “Controlled Remediation”. We’ll demonstrate the application of non-security, system administration, deployment, monitoring and change tracking using tools to achieve controlled remediation. This will build a foundation through which security, compliance, and change management goals can be achieved in an automated fashion within control system environments.
DevOps is a juxtaposition of the words “development” and “operations” and is meant to portray a tight relationship between the two traditionally separate roles which build and operate complex computer systems and software applications. DevOps groups work with a unified goal to rapidly and reliably deploy and manage the underlying systems which organizations rely upon to make a profit while balancing resource constraints.
“Controlled Remediation” is a concept used to describe the use of automation to maintain acceptable configuration and settings on industrial cyber assets. Additionally, this presentation will discuss the variations of “Automated Remediation” and “Manual Remediation”.
Cornerstone’s July 29th webinar with Educe Group entitled “Fearing the Cloud: Why the Life Sciences Shouldn’t Fret,” focused on compliance in the cloud in Life Sciences. As with any software utilized within the Biotech and Pharma industry, it is important to understand the overall business intended use and the regulatory and compliance components that drive the overall validation and implementation efforts. This includes a risk-based approach to validation based on the criticality of the business intended use. As with any software, it is very important to understand what the software development process is and how the software is deployed. This is especially true of Cloud-based service models (e.g., IaaS, PaaS, SaaS). This session will focused on the these service models and more importantly considerations for how they should be managed within the Life Sciences industry.
The medical device industry is facing unprecedented challenges due to emerging technologies and increased regulatory scrutiny.
Current “waterfall” product development methods are ill-suited to dealing with the pace of change and uncertainty that product development organizations are facing. This eBook addresses:
* The shortcomings of waterfall development specifically in regulatory environments.
* How agile development meets the safety, reliability and regulatory needs of the medical device and diagnostics industry.
* How agile development can help ensure delivery of successful software.
This presentation reviews the regulatory requirements for intended use validation of SaaS-based EDC systems from the Sponsor and CRO perspective and provides best practices for implementing the proper validation in your organization.
Presentation by Pathfinder Software to the Agile Project Management Group and Health 2.0 group on how to get the benefits of agile development in an FDA regulated environment, based on Pathfinder's experience developing software for medical devices
Life science companies struggle to receive and manage product safety related information through their safety email inbox. The lack of audited tracking and the inability to control the entire intake process present risks to safety departments. Most often, safety email inboxes are described as "black holes" where all information comes in but is difficult to manage.
At this one-hour webinar, we will show you how November Research Group can solve your common pharmacovigilance challenges with a simple and effective solution. The purpose of this webinar is to empower you with more control over your case intake process.
In this session with Brad Gallien, you will discover:
- Common challenges pharmacovigilance departments face in the safety email inbox process
- A systematic approach to better manage the intake and review of potentially reportable adverse events and complaints
- An easy and efficient way to communicate with reporters through correspondence management
- Industry best practices to prepare for intake process audits and inspections
The IT Auditing Series is a series of 10 2-hour webinars.
The study program consists of 5 modules Basic and 5 modules Advanced spanning a broad range of topics and issues in the IT Auditing field. The emphasis in all webinars is therefore on practical aspects, of Internal Auditing.
The course content is based upon ISACA Framework which has been accepted world-wide as the basis of skills and competencies required for all IT Auditors.
This webinar covered Fundamentals of IT Audit
Life science companies have the responsibility to collect, assess and potentially report any adverse event (AE) information that field sales representatives or clinical research associates learn while in the field. The task of collecting that report from the health care provider and communicating it to the company's product vigilance team, however, is only a small part of the field sales representative's or clinical research associate's job requirements. Life science companies' field personnel require a simple, modern and effective solution to automate this task so they can focus their time on other important responsibilities.
At this one-hour webinar, we will show you how our mobile AE intake tool, PRIMO Mobile, empowers your field sales representatives, clinical research associates and product safety team members with a comprehensive and easy-to-use solution to manage the case data intake process on their tablets, smartphones or laptops.
In this session with Brad Gallien, you will discover:
- How to utilize your field representatives' standard tablet, smartphone or laptop to quickly and easily submit adverse events they uncover in the field.
- The power and flexibility of mobile solutions to support AE intake challenges
- A fast and powerful way to facilitate communication between the product vigilance department and field representatives
- A modern approach to manage the intake and review of potentially reportable adverse events and product complaints
Why a Risk Assessment is NOT Enough for HIPAA ComplianceCompliancy Group
A common misconception is that “A risk assessment makes me HIPAA compliant” Sadly this thought can cost your practice more than taking no action at all. A risk assessment is a requirement for HITECH under Meaningful Use Core Measure 15, but it does NOT make you HIPAA compliant. Furthermore it can enter you into the section of willful neglect and open your organization into the next level of fines.
Join industry experts to find out how you achieve Meaningful Use, HITECH and HIPAA compliance while protecting your practice. Don’t miss this webinar, it could be the biggest message you receive all year!
The IT Auditing Series is a series of 10 2-hour webinars.
The study program consists of 5 modules Basic and 5 modules Advanced spanning a broad range of topics and issues in the IT Auditing field. The emphasis in all webinars is therefore on practical aspects, of Internal Auditing.
The course content is based upon ISACA Framework which has been accepted world-wide as the basis of skills and competencies required for all IT Auditors.
This session covers audit use of CAATs
Spurred to action by HITECH, the U.S. Department of Health and Human Services has started to enforce HIPAA regulations through a series of random audits. In 2014 the audits are expected to extend to Business Associates. In this session, attorney Richard Wagner will cover the five crucial steps that Covered Entities and Business Associates alike will need to take now to survive an unexpected audit.
Agile Development for FDA Regulated Medical SoftwareOrthogonal
The FDA regulates software for medical devices, and may in future regulate mobile medical software as well. Can you speed up time to market with Agile development in an FDA regulated medical environment?
Pathfinder Software shares their experience developing software using lean ux and agile software development best practices for medical devices and mobile medical software.
The IT Auditing Series is a series of 10 2-hour webinars.
The study program consists of 5 modules Basic and 5 modules Advanced spanning a broad range of topics and issues in the IT Auditing field. The emphasis in all webinars is therefore on practical aspects, of Internal Auditing.
The course content is based upon ISACA Framework which has been accepted world-wide as the basis of skills and competencies required for all IT Auditors.
This session covers auditing contingency planning
Handbook for financial institutions on assessing and instituting critical security controls in their company. Detail analysis of process for controls and risks affecting companies.
This is my current work and thinking on how to do Scrum within heavily regulated industries like healthcare, government, and finance. For more information join my community at http://scrumandcompliance.com/
This presentation reviews the regulatory requirements for intended use validation of SaaS-based EDC systems from the Sponsor and CRO perspective and provides best practices for implementing the proper validation in your organization.
Presentation by Pathfinder Software to the Agile Project Management Group and Health 2.0 group on how to get the benefits of agile development in an FDA regulated environment, based on Pathfinder's experience developing software for medical devices
Life science companies struggle to receive and manage product safety related information through their safety email inbox. The lack of audited tracking and the inability to control the entire intake process present risks to safety departments. Most often, safety email inboxes are described as "black holes" where all information comes in but is difficult to manage.
At this one-hour webinar, we will show you how November Research Group can solve your common pharmacovigilance challenges with a simple and effective solution. The purpose of this webinar is to empower you with more control over your case intake process.
In this session with Brad Gallien, you will discover:
- Common challenges pharmacovigilance departments face in the safety email inbox process
- A systematic approach to better manage the intake and review of potentially reportable adverse events and complaints
- An easy and efficient way to communicate with reporters through correspondence management
- Industry best practices to prepare for intake process audits and inspections
The IT Auditing Series is a series of 10 2-hour webinars.
The study program consists of 5 modules Basic and 5 modules Advanced spanning a broad range of topics and issues in the IT Auditing field. The emphasis in all webinars is therefore on practical aspects, of Internal Auditing.
The course content is based upon ISACA Framework which has been accepted world-wide as the basis of skills and competencies required for all IT Auditors.
This webinar covered Fundamentals of IT Audit
Life science companies have the responsibility to collect, assess and potentially report any adverse event (AE) information that field sales representatives or clinical research associates learn while in the field. The task of collecting that report from the health care provider and communicating it to the company's product vigilance team, however, is only a small part of the field sales representative's or clinical research associate's job requirements. Life science companies' field personnel require a simple, modern and effective solution to automate this task so they can focus their time on other important responsibilities.
At this one-hour webinar, we will show you how our mobile AE intake tool, PRIMO Mobile, empowers your field sales representatives, clinical research associates and product safety team members with a comprehensive and easy-to-use solution to manage the case data intake process on their tablets, smartphones or laptops.
In this session with Brad Gallien, you will discover:
- How to utilize your field representatives' standard tablet, smartphone or laptop to quickly and easily submit adverse events they uncover in the field.
- The power and flexibility of mobile solutions to support AE intake challenges
- A fast and powerful way to facilitate communication between the product vigilance department and field representatives
- A modern approach to manage the intake and review of potentially reportable adverse events and product complaints
Why a Risk Assessment is NOT Enough for HIPAA ComplianceCompliancy Group
A common misconception is that “A risk assessment makes me HIPAA compliant” Sadly this thought can cost your practice more than taking no action at all. A risk assessment is a requirement for HITECH under Meaningful Use Core Measure 15, but it does NOT make you HIPAA compliant. Furthermore it can enter you into the section of willful neglect and open your organization into the next level of fines.
Join industry experts to find out how you achieve Meaningful Use, HITECH and HIPAA compliance while protecting your practice. Don’t miss this webinar, it could be the biggest message you receive all year!
The IT Auditing Series is a series of 10 2-hour webinars.
The study program consists of 5 modules Basic and 5 modules Advanced spanning a broad range of topics and issues in the IT Auditing field. The emphasis in all webinars is therefore on practical aspects, of Internal Auditing.
The course content is based upon ISACA Framework which has been accepted world-wide as the basis of skills and competencies required for all IT Auditors.
This session covers audit use of CAATs
Spurred to action by HITECH, the U.S. Department of Health and Human Services has started to enforce HIPAA regulations through a series of random audits. In 2014 the audits are expected to extend to Business Associates. In this session, attorney Richard Wagner will cover the five crucial steps that Covered Entities and Business Associates alike will need to take now to survive an unexpected audit.
Agile Development for FDA Regulated Medical SoftwareOrthogonal
The FDA regulates software for medical devices, and may in future regulate mobile medical software as well. Can you speed up time to market with Agile development in an FDA regulated medical environment?
Pathfinder Software shares their experience developing software using lean ux and agile software development best practices for medical devices and mobile medical software.
The IT Auditing Series is a series of 10 2-hour webinars.
The study program consists of 5 modules Basic and 5 modules Advanced spanning a broad range of topics and issues in the IT Auditing field. The emphasis in all webinars is therefore on practical aspects, of Internal Auditing.
The course content is based upon ISACA Framework which has been accepted world-wide as the basis of skills and competencies required for all IT Auditors.
This session covers auditing contingency planning
Handbook for financial institutions on assessing and instituting critical security controls in their company. Detail analysis of process for controls and risks affecting companies.
This is my current work and thinking on how to do Scrum within heavily regulated industries like healthcare, government, and finance. For more information join my community at http://scrumandcompliance.com/
Software validation do's and dont's may 2013John Cachat
Software validation is often times a very misunderstood concept. For FDA regulated industries, there are clear expectations including “the least burdensome approach.” Validation alone does not guarantee software quality—many other aspects of software engineering are required.
Join software expert, John Cachat, as he discusses how to solve several software validation issues, including:
Requirements
Defect Prevention
Time and Effort
Software Life Cycle
Plans
Procedures
Software Validation After a Change
Validation Coverage
Independence of Review
Flexibility and Responsibility
V-model in software testing means Verification and Validation model. Much the same as the waterfall model, the V-Shaped life cycle is a consecutive path of execution of procedures. Every stage must be completed before the following stage starts. Testing of the product is arranged in parallel with a parallel stage of development in V-model.
Computer System Validation (CSV) is a core requirement for several industries. The aim of Computer System Validation is to ensure, through documentation, that the computer systems function the way they are intended to, consistently, repeatedly and reproducibly, somewhat in the manner expected of scientific experiments. So, the validation, meaning authentication or corroboration, is something that has to be done right from the start, that is, defining the computer system, to their use and going all the way right up to the time the computer system is retired.
Applying Technologies Across the End-to-End Pharmacovigilance Process to Incr...MyMeds&Me
MyMeds&Me CEO Andrew Rut and Oracle Health Science's Director of Safety Analytics, Michael Braun-Boghos review the positive impacts of technology on current pharmacovigilance processes.
Security is an important factor in IT project management. This presentation highlights security implications in delivering IT projects by focusing on project management processes, and Software Development Life Cycle. This also highlights how to implement security in Waterfall and Agile delivery methods. In addition, this presentation details delivering quality software by aligning project level strategies with organization’s security strategy and process.
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Your team is up and running with Splunk. Now you want to maximize your investment and solve additional business problems. Hear how to expand beyond the initial use case. Learn how to how to capture, document and present Splunk's data and present impactful ways to calculate ROI using concrete metrics; cost savings, time savings, efficiency gains, and competitive advantage.
Banks and other financial services firms need to recognize the threats of cyber risk in a different way. Many have put in place thick walls to protect themselves. But firms cannot be protected at all times from a cyber-related incident. So putting in place structures, technologies and processes to ensure resilience—or fast recovery—is as much or more important than simply putting more locks on the doors or building stronger walls. See www.accenture.com/CyberRisk for more.
Suitability of Agile Methods for Safety-Critical Systems Development: A Surve...Editor IJCATR
Lately, agile methods have widely been used in large organizations. This contrasts to previous practice, where they were mainly
used for small projects. However, developers of safety critical systems have shied away from using these methods for the right and wrong
reasons. Adoption of agile methods for safety critical system development is low and there is need to find out why this is so especially
since agile methods allow a more relaxed approach towards documentation, flexible development lifecycle based on short iterations and
accommodates changing requirements. This paper presents a report of a detailed analysis of literature and aims to shed light on the
suitability of agile methods for developing safety critical systems .The findings indicate that many organizations are relying on traditional
methods to develop safety critical systems because they are familiar with them and have been thoroughly tested over time. However with
the advent of agile methods there is a paradigm shift by non safety critical system developers, nevertheless this is not happening with the
safety critical system developers and there is need to find out why.
Customers talk about controlling access for multiple erp systems with oracle ...Oracle
Customer discuss using Oracle GRC Advanced Controls to help manager access to Multiple ERP's.
Eugene Hugh from InterContinental Exchange and Stephen D’Arcy from PWC explain how ICE and NYSE managed operational controls and met compliance requirements in a challenging ERP environment by using Oracle Advanced Controls. You can learn more about this by downloading the presentations from here.
Understanding New Technology and Security Risks as you respond to COVID-19Emma Kelly
As world economies reopen, businesses must adjust their risk management posture for the “new normal”, while continuing to drive digital transformation initiatives. The “new normal” has brought change to key risk vectors across people, process, and technology. To enable effective financial and operational controls, business teams must adapt to these changes and fully understand these new technology and security risks.
A key change has been a move to a work from home workforce. Organizations must rethink their approach to approach to enabling employee access to key enterprise systems and sensitive data.
In this session, we will share our thoughts on where new risks have emerged and traditional risks have changed. In addition, we will provide a point of view on the latest technologies and techniques to help you assess and control risks in enterprise systems that enable business finance and operations management.
Join SafePaaS CEO Adil Khan and Director Dan Miller at Altum Strategy Group.
Since the spread of IT systems has made it a pre-requisite that auditors as well as management have the ability to examine high volumes of data and transaction in order to determine patterns and trends. In addition, the increasing need to continuously monitor and audit IT systems has created an imperative for the effective use of appropriate data mining tools.
While a variety of powerful tools are readily available today, the skills required to utilize such tools are not. Not only must the correct testing techniques be selected but the effective interpretation of outcomes presented by the software is essential in the drawing of appropriate conclusions based on the data analysis. This 6 webinar series, based on Richard Cascarino’s book “Data Analytics for Internal Auditors” covers these skills and techniques.
Webinar 4 Analysis and Monitoring 4/2/19
Data analysis and Continuous Monitoring
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Over 2/3rd of software development projects using agile method to deliver software quickly. As software releases become more frequent, testing processes have to keep pace and adopt continuous QA.
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The customer is a global Life Sciences company operating in over 50 international markets. With $5bn annual turnover it has more than 4000 employees.
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Life science companies need to ensure their business initiatives take advantage of social media analytics. Read about the challenge of maximizing the opportunity and generating value from real world patient insights.
It is an end-to-end integrated billing solution leveraging Oracle Projects Billing, Oracle Receivables and Oracle Workflow to address billing challenges.
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1. August 5, 2015 Proprietary and Confidential - 1 -
IT Compliance in 2015
Beyond the “V” Model
Arik Gorban
July 23, 2015
2. August 5, 2015 Proprietary and Confidential - 2 -
Today’s Speaker
Veteran on Computer Systems compliance with over 25 years of
experience in strategic regulatory compliance consulting, application
life cycle management, and quality system implementation for the
Life Sciences industry.
Has led IT compliance projects for many Life Science and technology
companies besides consulting major companies on global quality system
harmonization.
An international authority on risk-based approach to computer
validation and regulatory compliance management. Frequent lecturer
at professional conferences, user group meeting, and events on IT
compliance, validation, and Part 11 topics.
Leads the development of IGATE Life Sciences’ Quality & Compliance
practices and IGATE’s compliance solutions and services for Cloud
Computing and Mobility.
Leads client initiatives to integrate and harmonize IT-related compliance
strategies, methodologies, and tools across the organization and across
the regulatory landscape (e.g., FDA, SOX, and EU Annex 11).
Arik Gorban
Associate Vice President
Consulting & Solutions
IGATE, Life Sciences
3. August 5, 2015 Proprietary and Confidential - 3 -
Today’s Agenda
IT Compliance issues facing Life Sciences industry
Background – the industry today
New challenges
Lean, risk-based CSV
Real-life case study
Next steps
4. August 5, 2015 Proprietary and Confidential - 4 -
Objective
We’ll take a fresh look at CSV and risk management approach that is
effective, efficient, and enables the adoption of new technologies,
methodologies, and service models with external providers.
A validation process that:
Supports a true risk-based approach that is flexible and feasible with new
technologies (cloud, mobility, IoT), new system lifecycle approaches (Agile),
and new service models (SaaS).
Ensures the quality of the validated system.
Reduces business and operational risks.
Increases the level of regulatory compliance.
Reduces compliance costs.
5. August 5, 2015 Proprietary and Confidential - 5 -
Issues that often bother Life Sciences executives
I feel frustrated with the
cost and effort
associated with the
Computer System
Validation (CSV).
My vendor tells me that
they validated the
system that we want to
implement but QA tells
me that we still need to
validate it.
We have detailed
procedures and
extensive training but
still inadequate results.
Repeated review cycles
of validation
documentation is
causing costly project
delays.
We are under pressure
to reduce IT costs and
adopt new technologies
and methodologies, but
our validation process
prevents us from doing
that.
My projects suffer from
long debates and re-
work due to different
opinions on CSV related
activities.
Our risk-based approach
takes longer and costs us
more than our old
process.
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Issues & Opportunities in IT Compliance
High
Low
Cost
High
Opportunitiestoreducecostsandreducerisks
5%
65%5%
Quadrant II:
High risk
Lack of CSV understanding
Over-spend
Still not-compliant
Quadrant I:
High risk
Under-spend
Non-compliant
Low
20%
5%
“In compliance”
and
“Budget-right”
Quadrant IV:
Highly-compliant
Under-spend
Not attainable
Risk
Quadrant III:
Inefficient, ineffective CSV
Over-spend on marginal
value add activities
Highly compliant
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Background – Industry Today
Validation principles did not change in the last two decades.
Part 11 added some requirements for electronic records and signature
but did not impose new validation requirements.
Attempts to implement harmonized and consistent risk-based CSV as an
effective way to optimize the validation process often result in more
cumbersome and costly validation.
Validation planning discussions are typically focused on the V-Model’s
system lifecycle (SLC) phases and deliverables.
SLC artifacts are the focus, not system quality and risk mitigation.
Risk assessments focus on testing to determine how much IQ, OQ, and
PQ are necessary.
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Background – Industry Today
Risk assessments often neglect to address risk areas, such as:
– User account management, system availability, data protection, user
competency, system support, data ownership, non-traditional software
development and technologies
The right technical, business, and regulatory experts don’t always
participate
The industry needs to address new challenges:
– Cloud Computing
– Mobility and IoT – Technology and Application
– SaaS – Software as a Service Delivery Model
– Agile Software Development Methodology
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Risks in Today’s Environment
Evolving technologies and service models
Evolving expectations and practices
Lack of transparency (actual providers, locations, support, quality
practices...)
Use of open source
Rapid software development approaches
Security gaps and exposure
Availability of system and data (short term and long term)
Quality and compliance gaps
It’s new. We don’t know what we don’t know.
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Lean Risk-Based CSV
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“V” Model
User Requirements
Specification
Functional
Specification
Architecture Design
Specification
User Acceptance
Testing (PQ)
Validation
Report
Validation
Plan
VERIFIES
VERIFIES
VERIFIES
Installation
Qualification (IQ)
Software Design
Specification/Build
Development
Testing
(Unit, System)
Functional Testing
(OQ)
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Risk Assessment Types
System
Categorization
Based on type of system: custom
development, configured product
(COTS), turnkey COTS, layered
product, embedded software, smart
devices, etc.
Determine which validation
process applies (validation /
qualification / verification)
Risk Profile
(High-Level)
Based on the regulatory, operational
and business risks associated with the
system (e.g., GxP applicability, privacy
requirements, SOX applicability, and
business complexity and criticality)
Define the overall validation
strategy and required
deliverables
Functional Risk
Assessment
Based on operational and regulatory
risk
Determine requirements for
negative and boundary testing in
OQ
Determine which processes to
test in PQ
The table below describes the three levels of categorization and risk
assessment that should be followed for computer system applications.
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Data modification
Regulatory un-preparedness
Data loss
Lack of traceability
Mis-use of system
Data accuracy
Incorrect process - system
Incorrect process - people
Data falsification
System unavailability
Risk Priority-before Revised Risk-after mitigation
Lowest risk at outer edge
Highest in the center
System Risk Profile
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Lean Risk-Based CSV
Avoid the mechanical and rigid CSV. Lean, risk-based CSV should be
supported by the appropriate organization, people, methodology,
process, execution, and tools.
Organization – clear governance, roles, responsibilities, and authorities;
that facilitates a true risk based approach and ensures consistent
interpretation of regulatory requirements.
People – fully trained competent individuals with uniform interpretation
throughout the corporation and trained business owners.
Methodology – single, fully matured set of standards with integrated risk
analysis and enhanced risk-based approach that goes beyond functional
risk evaluation.
Process / Execution – flexible process that follows a risk-based plan.
Tools – templates, guidance documents and quality reviews are consistent
and targeted to drive value.
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Case Study
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Real Life Scenario – the Problem
A company planned a move to a new location.
They planned to move the whole infrastructure as is.
There will be no new equipment, software, or configuration, besides
new network layouts inside the building and new connections to the
outside (e.g., power, network, and phone lines).
Initial validation discussions focused on how much IQ, OQ, and PQ.
Some insisted that all are required; some felt that PQ (user acceptance)
is not required; and some suggested partial IQ, OQ, and PQ.
The discussions focused on standard validation phases and deliverables,
rather than risks and mitigations.
The team was focused on the artifacts, not on quality objectives.
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Real Life Scenario – the Approach
Shifted the focus from artifacts to risk management
Created a list of bullets that describe what can go wrong with the
data center move
– incorrect assembly
– hardware components break or get lost
– faulty network wiring
– wireless network unreliable
– incorrect network configuration
– unstable power supply
– physical security issues
– other transport, assembly, and location-related risks
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Real Life Scenario – the Approach
Identified risk mitigation actions
– reduce the impact
– reduce the likelihood
– or allow early detection
Mitigation actions included
– configuration documentation activities
– inventory of parts
– labeling wires and components
– writing assembly scripts
– testing connectivity
– verifying that systems and applications start correctly
– printing
– verifying power supply
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Real Life Scenario – the Approach
The proposed activities were focused on risk mitigation and
quality and compliance objectives, not driven by a list of
deliverables.
The last step was mapping the activities and documentation to
applicable system lifecycle phases and deliverables.
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Benefits
Clarity on how to manage risk
Effective Data Center Move Quality Plan
Mitigation to reduce potential operational, regulatory,
and business risks
Quality Plan ensured that activities and documentation
met applicable company standards
Management was able to evaluate real risks and actions
The approach did not cut corners and sacrifice quality,
but increased quality and compliance
Avoided allocating costly resources to low-value tasks
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Next Steps
Start with an overall strategy that takes into consideration
short term and long term investments, risks, required controls,
and benefits.
The plan and investment in a compliant environment must
consider an evolutionary process which will allow the
technology, controls, validation approaches, and training to be
tested and refined.
Create a list of “risks” for your new environment. Identify
which of the “risks” are:
True risks to the integrity, quality, reliability, or availability
of the data
Compliance risks
Gaps from current expectations, but not risks
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Next Steps
Adjust your Quality System, including system lifecycle and
computer system validation policies, procedures, work
instruction, guidelines, and templates to ensure that they can
be followed when systems are implemented in a new
environment.
Work with Compliance Subject Matter Experts to drive a true
risk-based approach.
Work with your internal stakeholders to ensure that the
approach is acceptable and defendable.
Follow Life Sciences industry trends with
regard to utilizing new technologies in regulated
environments. Monitor agency activities, statements, and
regulatory actions in order to understand their interpretation
and expectations.
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Conclusion
Taking a fresh look at a risk-based approach to CSV would be
very useful in dealing with today’s dynamics due to new
technologies, software and service delivery models, and
frequent organizational changes.
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THANK YOU!
www.igate.com
For additional information or questions, please contact us by email
arik.gorban@igate.com