Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.
The approach to developing software, performing validation and maintaining a system in a validated state through its entire life cycle should be carefully considered in order to meet changing needs. This seminar will include a comparison of the Agile and Waterfall methodologies, along with the pros and cons of each. There may not be one size that fits all, and so it is important to understand what needs to be considered when making such a determination.
As part of the Case for Quality program US FDA Center for Devices and Radiological Health noted how an excessive focus by industry on compliance rather than quality may be diverting resources and management attention toward meeting regulatory compliance requirements vs. adopting best quality practices. There has also been a lower than anticipated investment in automation and digital technologies, which could greatly improve quality and process control. A key element is a risk-based, product quality and patient-centric approach to Computer System Assurance (CSA) vs. the traditional Computer System Validation (CSV) Waterfall approach. This encourages critical thinking based on product and process knowledge and quality risk management over prescriptive documentation driven approaches.
This is where FDA determined that “WHAT” is required can be done (the “HOW”) in different ways and does not have to be according to the “checklist” mindset of most CSV work, where you crank out documents without specifically addressing the risk of potential failure of each requirement.
GAMP5 supports the use of incremental, iterative, and evolutionary approaches including Agile, for development of custom applications. Keys to success include a robust Quality Management System and well trained and highly disciplined teams following well-defined processes supported by tools and automation.
We will also discuss the important aspects of CSV and how to apply them in a new and modern technological environment.
The approach to developing software, performing validation and maintaining a system in a validated state through its entire life cycle should be carefully considered in order to meet changing needs. This seminar will include a comparison of the Agile and Waterfall methodologies, along with the pros and cons of each. There may not be one size that fits all, and so it is important to understand what needs to be considered when making such a determination.
As part of the Case for Quality program US FDA Center for Devices and Radiological Health noted how an excessive focus by industry on compliance rather than quality may be diverting resources and management attention toward meeting regulatory compliance requirements vs. adopting best quality practices. There has also been a lower than anticipated investment in automation and digital technologies, which could greatly improve quality and process control. A key element is a risk-based, product quality and patient-centric approach to Computer System Assurance (CSA) vs. the traditional Computer System Validation (CSV) Waterfall approach. This encourages critical thinking based on product and process knowledge and quality risk management over prescriptive documentation driven approaches.
This is where FDA determined that “WHAT” is required can be done (the “HOW”) in different ways and does not have to be according to the “checklist” mindset of most CSV work, where you crank out documents without specifically addressing the risk of potential failure of each requirement.
GAMP5 supports the use of incremental, iterative, and evolutionary approaches including Agile, for development of custom applications. Keys to success include a robust Quality Management System and well trained and highly disciplined teams following well-defined processes supported by tools and automation.
Why Should You Attend:
The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry. We will discuss ways to modernize the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV) by using automated testing tools that will result in a continuous validation of software products. This approach is amenable to the Agile software development methodology, which can be adapted for use in validation.We will also discuss the important aspects of CSV and how to apply them in a new and modern technological environment.
SEMINAR OBJECTIVE:
- “GxP” Systems
- Computer System Validation (CSV)
- Computer Software Assurance (CSA)
- System Development Life Cycle (SDLC)
- CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11
- Validation deliverables, including the Validation Plan, Requirements Specification, Test Plan, Validation Tests (IQ, OQ, PQ), Requirements Traceability Matrix, Test Summary, and Validation Report, etc.
- Develop a cohesive and comprehensive validation rationale
- Comprehend a risk-based validation technique
- Learn appropriate validation strategies for Cloud/SaaS, COTS, spreadsheets, and custom developed systems
- Learn how to apply an agile methodology to implementation and validation work, including automated testing
- Learn best practices for documenting validation, both for a traditional CSV and an agile approach
- Maintain a system in a validated state
- Learn about continuous validation through automated testing
- Assure the integrity of data that supports GxP work
- Policies and procedures needed to support validation
- FDA’s current thinking and trends
- FDA inspection or audit preparation
- Vendor Audit
- Finally, understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle
- Q&A
Course Content
Day 1- Identifying “GxP” Systems
- Current state of CSV approach based on FDA requirements
- Agile approach to System Development Life Cycle (SDLC)
- Pros and Cons of an Agile vs. Waterfall approach
- Cloud computing and Software as a Service (SaaS) systems
- Agile continuous validation approach
- Policies and procedures needed to support your validation process
- Q&A
- CSA Gap Assessment
- Keys to a Successful CSA Implementation
- Documentation using a Waterfall or Agile approach
- Implementing CSA Across the organization - Avoiding disorientation
- Applicability of CSA Guidance to Data Integrity
- IT Supplier Assessments While Adopting CSA Principles
- Risk Assessment to optimize your validation approach
- Q&A
Speakers
Carolyn TroianoCSV & FDA Compliance Expert
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.
Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.
