Overview:
Computer
System Validation (CSV) has been regulated by FDA for more than 35 years, as it
relates to systems used in the manufacture, testing, distribution, and
management of a product in the pharmaceutical, biotechnology, medical device,
tobacco, and related industries. The requirements phase of the CSV process is a
key aspect of validating a system by providing the functions and features the
user will require to perform their operations.
The
course will focus on the key aspects of requirements development and
management, including best practices and principles for handling this key
component of project work in an FDA-regulated environment (i.e., the system
“touches” product during the manufacturing, testing or distribution of the
product, or during any other functional activity). The material will include the various aspects
of how to develop requirements, and the result will be a prescriptive approach
to helping teams and individuals reach a higher level of compliance. It will also provide guidance on how to keep
costs low and avoid “scope creep,” which can lengthen the time and require more
money to achieve.
Requirements
include both functional and non-functional, or system requirements. We’ll
describe the differences and elaborate on the key characteristics of a good
written requirement. The approach includes determining risk at the requirement
level, providing a risk rating for each that can be used to determine the type
and level of testing required.
Requirements
at a high level should be documented using business terminology to describe the
intended use of the system. The high-level requirements are then used as a
basis for developing the unique functional requirements and non-functional, or
system requirements. Requirements will be mapped to the one or more test
script(s) that will be executed to prove the requirement is met.
Learn
about the best practices for preparing detailed requirements during CSV,
including the acceptance criteria that must be met to assure the requirement is
proven through testing.
We
will also cover Computer Software Assurance (CSA), the draft guidance issued by
FDA in September 2022. CSA provides a pathway for streamlining the validation
process, focusing on areas of functionality that could potentially cause risk,
if they failed to be met. Using a risk-based approach, the attendee can learn
the best practices for creating and executing against a specific risk
methodology.
CSA
also includes automated testing and critical thinking, each of which we will
touch upon during the session. Note that GAMP®5, Second Edition was issued in
July 2022, and we will talk about how it aligns with the concepts behind CSA.
Both GAMP®5, Second Edition and CSA align with an agile methodology for
software development and testing. We’ll show you how the GAMP®5 “V” Model can
be aligned with agile, as well.
Areas
Covered in 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?
You
should attend this webinar if you are part of a team developing requirements
for a system that is regulated by FDA. This is for a new system or an update to
an existing system where functionality might be changed. Typically, Subject
Matter Experts (SMEs) who understand the business process and can map it to
specific functional requirements.
Note
that system, or non-functional requirements are the “enablers” of functionality
and must be present for the functionality to be delivered. This should also be
attended by the technical resources who understand the system needs.
What
industries will benefit from this 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?
- 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, Functional Requirements, System Requirements, Regulatory Compliance, Medical Device, Pharmaceutical, FDA Webinar, Dayna Reum, June 2023,