In-Depth Functional and System Requirements for Computer Systems Regulated by FDA

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In-Depth Functional and System Requirements for Computer Systems Regulated by FDA

Learning Objectives

To discuss the characteristics of well-written requirements.
To analyze where to gather information and who to speak with when preparing a requirements specification.
To discuss the importance of clearly written, well-defined requirement definition.
To analyze how the requirements will set the tone for CSV testing.
To inspect the Requirements Traceability Matrix (RTM) that links every requirement with one or more test scripts that support it.
To investigate how to rate the potential risk of a requirement failing and how this influences testing during CSV.
To identify functional vs. non-functional, or system requirements.

Course Description

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.

This CPE 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 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 guide 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 well-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 one or more test script(s) that will be executed to prove the requirement is met.

This CPE webinar will help you to 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.

Webinar Qualifies For

1.5 CPE Credit of Information Technology for Certified Public Accountants (CPA-US)
1.5 General Credit for Accountant/Bookkeeper/Tax Professionals
1.5 CPE Credit for Certified Information Systems Auditor (CISA)
1.5 CPD Credit for Certified Information Technology Professionals (CITP)
1.5 CPE Credit for Certified in Risk and Information System Control (CRISC)
1.5 CE Credit for Certified Wealth Strategist (CWS)
1.5 CE Credit for Certified Fiduciary and Investment Risk Specialist (CFIRS)

About Instructor

Carolyn Troiano

Account Executive, BrainStorm Central Consulting LLC

Carolyn Troiano has more than 35 years of experience in computer system validation and compliance in the pharmaceutical, medical device, 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.

Additional Information

Duration

1.5 Hours

Course Level

Basic

Instructional Method

Group Internet Based

Pre-requisites

None

Advance Preparation

None

FAQ’s

Click Here to View

NASBA APPROVED

MY-CPE LLC, 1600 Highway 6 south, suite 250, sugar land, TX, 77478

MY-CPE LLC (Sponsor Id#: 143597) is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE Sponsors. State boards of accountancy have final authority on the acceptance of individual courses for CPE credit. Complaints regarding registered sponsors may be submitted to the National Registry of CPE Sponsors through its website: www.NASBARegistry.org.

Ratings and Review

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Michael Ricozzi, CPA (US)

instructor appeared to be an expert in this area .. great info

1.5 Credits

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Subject Area

Information Technology

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In-Depth Functional and System Requirements for Computer Systems Regulated by FDA

Course Details

Learning Objectives

Course Description

Qualifies for

Webinar Qualifies For

Presenter Details

About Instructor

Carolyn Troiano

Other Details

Additional Information

1.5 Hours

Basic

Group Internet Based

None

None

FAQ’s

NASBA APPROVED

Ratings and Review

5

Michael Ricozzi, CPA (US)

Subject Area

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