Overview:
The
validation of computer systems (CSV) under FDA regulations has shaped the way
essential systems are designed, tested, and managed within FDA-regulated
industries, including pharmaceuticals, biotechnology, medical devices, and
more, for over 35 years. The requirements phase is an essential cornerstone of
this validation, defining the critical functions and features that enable these
systems to support safe and compliant operations across manufacturing, testing,
and distribution.
Effective
requirements development and management remain pivotal in FDA-regulated
environments, serving as a foundation for compliant project execution. In the
context of FDA oversight, any system that "touches" a product—whether
during manufacturing, testing, distribution, or other critical operations—must
adhere to these stringent standards. Building robust requirements means
addressing multiple layers, from capturing functional needs to managing
non-functional, or system, expectations, each of which aligns the system with
both operational goals and regulatory demands.
The
journey of requirements development touches on multiple facets. High-level
requirements are often expressed in business terms, establishing a clear
intention for system use. These overarching requirements then lay the
groundwork for more detailed functional and non-functional specifications, each
meticulously mapped to test scripts that validate compliance. Addressing
requirements systematically is key, from assessing risk and rating each
requirement’s impact to defining the scope of testing needed to confirm
compliance.
CSV
requirements extend beyond traditional documentation. They encompass practices
that prevent "scope creep"—a common risk that drives up costs and
prolongs timelines—as well as practices that safeguard operational efficiency
and compliance. Clearly defined requirements ensure that projects stay on
track, with a particular focus on functional and system-level specifics that
meet user needs without compromising on regulatory compliance.
With
these principles in mind, Computer Software Assurance (CSA) enters as an FDA
draft guidance issued in 2022, offering a risk-based pathway to validation. CSA
shifts the focus to functionality most critical to compliance and patient
safety, emphasizing a streamlined approach that targets high-risk areas first.
This draft guidance, along with GAMP®5’s updated second edition (issued in
2022), supports agile methodology for software development, aligning with
modern needs for responsive and efficient validation processes. The
"V" Model, long a standard in GAMP®5, shows flexibility in combining
CSA principles with agile development and testing, balancing regulatory rigor
with adaptive project management.
Throughout
this process, requirements traceability becomes invaluable. The Requirements
Traceability Matrix (RTM) captures each requirement’s relationship with test
scripts, reinforcing compliance from specification to execution. This approach
not only supports thorough testing but also enables systematic monitoring of
each requirement’s risk profile, addressing both functional and non-functional
needs at every phase.
This
course, in its detailed exploration, will address these best practices for
preparing detailed requirements within CSV, including crafting acceptance
criteria that affirm compliance through targeted testing.
Areas
covered during the session:
- Learn
the characteristics of well-written requirements
- Learn
where to gather information and who to speak with when preparing a requirements
specification
- Understand
the importance of clearly written, well-defined requirement definition
- Understand
how the requirements will set the tone for CSV testing
- Learn
about the Requirements Traceability Matrix (RTM) that links every requirement
with one or more test scripts that support it
- Learn
how to rate the potential risk of a requirement failing and how this influences
testing during CSV
- Identify
functional vs. non-functional, or system requirements
- Understand
the approach for software development following GAMP®5, Second Edition and
FDA’s draft guidance for Computer Software Assurance (CSA); these two are very
aligned
- Learn
how to capture the requirements electronically
- Q&A
Why
should you attend?
In
FDA-regulated industries, managing system requirements is critical for
compliance, efficiency, and cost control. This webinar will equip you with best
practices to develop robust requirements for Computer System Validation (CSV),
minimizing project risks and preventing costly scope creep.
Gain
clarity on the FDA’s latest guidance on Computer Software Assurance (CSA) and
its practical applications for a risk-based approach. This insight will help
you streamline validation processes, focusing efforts where they matter most
for compliance.
By
joining, you’ll be better prepared to meet evolving regulatory expectations
while strengthening your validation practices, from requirements documentation
to agile project management. This session is invaluable for professionals
seeking efficient, compliant CSV strategies.
What
industries will benefit from your training?
Manufacturing,
Testing, Packaging and Distribution companies in the following industries that
are regulated by FDA are required to follow GxPs:
- Pharmaceutical
(for drug products introduced using a medical device)
- Medical
Device
- Biologicals
(for biological products introduced using a medical device)
- Tobacco
(based on the Tobacco Control Act of 2009)
- E-Liquid/Vapor
(based on the “Deeming” Act of 2016)
- E-Cigarette
(based on the “Deeming” Act of 2016)
- Cigar
(based on the “Deeming” Act of 2016)
- Third-Party
companies that support those in the above industries, including Contract
Research Organizations (CROs)
- Colleges
and Universities offering programs of study in Clinical Trial Management and
Regulatory Affairs/Matters related to FDA
Who
will benefit?
Personnel
in the following roles will benefit:
- Information
Technology Analysts
- QC/QA
Managers
- QC/QA
Analysts
- Clinical
Data Managers
- Clinical
Data Scientists
- Analytical
Chemists
- Compliance
Managers
- Laboratory
Managers
- Automation
Analysts
- Manufacturing
Managers
- Manufacturing
Supervisors
- Supply
Chain Specialists
- Computer
System Validation Specialists
- GMP
Training Specialists
- Business
Stakeholders responsible for computer system validation planning, execution,
reporting, compliance, maintenance and audit
- Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
- Auditors engaged in the internal inspection of labeling records and practices.
Carolyn Troiano has more than 40 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.
Enrollment Options
Tags: FDA Compliance, Computer System Validation (CSV), Functional Requirements, System Requirements, Computer Software Assurance (CSA), Regulatory Compliance, Medical Device Compliance, Pharmaceutical Compliance, GAMP5, Risk-based Testing, Agile Validation, Carolyn, Troiano, November 2024,