MS in Computer Systems Validation in Regulatory Affairs
Prepare IT professionals to manage US and global regulatory processes — mastering Computer System Validation, FDA compliance, and life sciences quality assurance.
Program Overview
The MS in Computer Systems Validation in Regulatory Affairs program consists of 30 graduate-level semester credit hours, of which 15 are foundation, 12 are concentration, and 3 are elective (including the option coursework, project, or internship).
The program includes 4 concentrations: (1) Concepts of Validation in Pharmaceutical Industry, (2) Regulatory Affairs in Pharmaceutical Industry, (3) Regulatory Compliance for Computer Systems in the Pharmaceutical Industry, and (4) 21 CFR Part 820 and ISO 13485 Regulations.
The program may be completed entirely on campus or through a combination of on-campus and online courses.
- 30-credit program with 4 industry-focused regulatory concentrations
- Mastery of FDA 21 CFR Part 11, EU Annex 11, and CSV standards
- Preparation for US and global regulatory process management
- Capstone Project, Internship, or coursework completion options
- Designed for IT professionals in life sciences and regulated industries
Our mission is to produce graduates who are highly qualified to manage US and Global Regulatory Processes for companies innovating and developing cutting-edge products in Life Sciences.
Program Objectives
The objective of the program is to prepare IT professionals to gain a comprehensive understanding of Computer System Validation (CSV), its significance in regulated industries, and the associated regulations and standards and the skills necessary to effectively manage electronic data in a regulated environment while ensuring compliance with regulatory guidelines such as FDA’s 21 CFR Part 11 and EU Annex 11. Graduates will earn a Master of Science degree with a major in Computer Systems Validation in Regulatory Affairs and this area of concentration recognizes that all IT professionals, regardless of position, can be called on to serve in regulatory affairs roles. As we look forward to the increasing use of artificial intelligence, we will require increasingly sophisticated computers, trained users, skilled IT professionals, and involved management. This program is designed to produce graduates who are highly qualified to manage US and Global Regulatory Process for companies innovating and developing cutting-edge products in Life Sciences.
CSV Compliance
Master Computer System Validation best practices for pharmaceutical and regulated industry environments.
FDA & EU Regulatory
Ensure compliance with 21 CFR Part 11, EU Annex 11, and other critical regulatory guidelines.
Data Integrity
Optimize approaches to validation and compliance based on risk assessment throughout the data life cycle.
FDA Audit Readiness
Prepare professionals for FDA inspections and audits of GxP computer systems with confidence.
All IT professionals, regardless of position, can be called upon to serve in regulatory affairs roles. This program ensures you are fully prepared when that moment comes.
Curriculum
The MS in Computer Systems Validation requires completion of the following 30 credit hours across three areas.
Credit Hour Summary
Admission Requirements
Application Submission
Submit a completed Graduate Admissions Application with the non-refundable application fee of $50.
Bachelor’s Degree in a Related Field
Bachelor’s degree in a related field from an accredited college or university in the United States or degree equivalent to a U.S. bachelor’s degree (outside U.S.) i.e. Bachelor’s degree in Computer Science / Electronics / Mechanical / IT, Pharmacy, Biology, Chemistry, Physics, Therapy, Engineering, Health Law, Health Policy, Home Sciences, Life-Sciences (Microbiology, Biochemistry, Biotechnology, Bioinformatics or related fields), or work experience in related field.
GPA Requirement
Admission requires a minimum undergraduate cumulative grade-point average of 2.0.
Academic Transcripts
Official transcripts are required. The prospective student must arrange to have an evaluation of your foreign transcript by one of the recognized Education evaluation companies. The cost for foreign transcript evaluation is the responsibility of the student.
Professional Resume
A current professional resume detailing your academic background and relevant work experience.
Letters of Recommendation
Two letters of recommendation from academic or professional references who can attest to your qualifications and potential.
Statement of Purpose
A detailed statement covering your career goals and interest in regulatory affairs and computer systems validation.
GRE (Optional)
GRE Optional
English Language Proficiency
Proof of English Language Proficiency (TOEFL/IELTS/PTE/Duolingo Score Report). Non-native English speakers who did not complete post-secondary education exclusively in the English language must provide proof of English language proficiency.
Proof of Funds
Documentation demonstrating sufficient financial resources to support your graduate studies.
Professionals from IT, life sciences, pharmacy, and engineering backgrounds will find this program ideally suited to their experience and career aspirations in regulatory affairs.
Degree Outcomes
Successful completion of the MS-CSV Program will enable students to:
Understand industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity throughout the entire data life cycle.
Examine quality systems and standards and their impact on product and public safety as well as the importance of quality products from the perspective of healthcare providers.
Manage the product life cycles of biopharmaceutical and medical devices from conception through launch to obsolescence.
Understand the key components of 21 CFR Part 11 compliance for electronic records and signatures.
Recognize the factors that influence domestic and international regulatory decisions across the pharmaceutical and life sciences industries.
Understand the policies and procedures needed to support the validation process and ongoing maintenance of systems in a validated state.
Know how to best prepare for an FDA inspection or audit of a GxP computer system and maintain ongoing validation states.
As a regulatory affairs specialist, help ensure the safety and compliance of life-saving products in a highly regulated industry. Trust Belcroft University to prepare you for this mission-critical role.
Credit for Prior Learning
A maximum of six credits of transfer credit or other approved prior learning credit may be applied toward a master’s degree program. Credit may be granted based on official transcripts, verified work experience, or professional certifications and must be approved by qualified faculty or the Admissions Department. Such credits are recorded as “Credit for Prior Learning,” carry no letter grade, and are excluded from GPA calculations.
Accepted Sources
- Official Transcripts
- Verified Work Experience
- Regulatory Certifications
- Up to 6 Credits Max
Key Conditions
- No Letter Grade Assigned
- Excluded from GPA
- Faculty Approval Required
Your professional experience in IT, pharma, and regulatory compliance represents real-world expertise. Belcroft University acknowledges your prior learning while maintaining our rigorous academic standards.
Career Options
A Master of Computer Systems Validation in Regulatory Affairs degree can academically prepare you to pursue career options such as:
Computer System Validation (CSV) Engineer
Validate computerized systems in pharmaceutical and biotech environments per regulatory requirements.
Validation Manager
Lead validation teams and oversee CSV processes across regulated manufacturing and quality systems.
Regulatory Affairs Director
Guide product regulatory strategy and submissions for FDA and international agency approvals.
Quality Assurance (QA) Specialist
Ensure product quality standards, audit readiness, and GMP compliance across the product lifecycle.
Regulatory Compliance Consultant
Advise pharmaceutical and medical device companies on achieving and maintaining regulatory compliance.
The MSCV program equips professionals with the specialized knowledge needed to navigate complex regulatory environments and lead compliance initiatives in life sciences organizations worldwide.
Work Settings
A Master of Computer Systems Validation in Regulatory Affairs degree can academically prepare you to work in settings such as:
Pharmaceutical & Biotech Companies
Medical Device Companies
Healthcare Organizations
Contract Research Organizations
Government & Regulatory Bodies
Life Sciences Manufacturers
MSCV graduates are prepared to serve in critical regulatory roles at pharmaceutical companies, medical device firms, government agencies, and global contract research organizations.