Why Are Computer System Validation Specialists Needed in the Pharmaceutical Industry?

What is Computer System Validation and How is it Done?

Pharmaceutical computer system validation has strict requirements due to the importance and complexity of pharmaceutical manufacturing. Fortunately, CSV specialists have formalized guidance to help them adequately test and validate computer systems in accordance with FDA requirements.

Good Automated Manufacturing Practice (GAMP 5) is a set of standardized guidelines that breaks down the computer system validation process into specific life cycle phases, with each life cycle containing particular activities. The pharmaceutical industry widely uses GAMP 5 computer system validation to adequately satisfy the FDA’s criteria described in FDA 21 CFR 11. 

FDA 21 CFR 11 describes specific controls that regulators need to see about each computer system. GAMP 5 provides actionable steps to achieve those controls.

The four GAMP 5 life cycle phases include:

1. Concept: A high-level understanding of the specific system
2. Project: A detailed description of the system and its objectives
3. Operation: How is the system managed while in operation?
4. Retirement: How is the system retired?

Additionally, support processes take place throughout every phase, such as document management, security management, risk management, and more.

Computer System Validation Basics

We know that CSV specialists follow a standardized process, but at a more basic level, what can a CSV specialist do? The exact tasks will vary based on the computer system being validated, but example duties of the role include:

• Maintaining accurate validation documentation through the process
• Write validation reports, review, and approve all SOPs involved in the validation
• Stay informed about changes and advances in the pharmaceutical industry with specific attention on regulatory requirements
• Involved in both external inspections and internal audits
• Recommend specific upgrades for existing processes
• Implement those upgrades
• Train the validation team or other staff members in the correct usage of computer systems to comply with regulations
• Review and update validation documents

Adequately performing each of the above duties, along with any others that may arise, calls for specialized training. General knowledge of computer systems is helpful, but will not be enough to be an effective CSV specialist without additional training.

Examples of Computer System Validation Regulation

Pharmaceutical manufacturing is a highly regulated industry. The controls and checks put in place by regulatory authorities help protect the general public while also giving patients confidence in the drugs being prescribed. 

Examples of current pharmaceutical regulations are:

• The Food and Drug Administration (FDA): Products manufactured anywhere in the world that are intended to supply the United States are subject to FDA regulations. FDA regulations don’t lock companies into a specific way of manufacturing their products but rather confirm that each company's approach fulfills the regulatory requirements. Code of Federal Regulations, Current Good Manufacturing Practice for Finished Pharmaceuticals describes the FDA’s specific take on GMP.
• European Medicines Agency (EMA): The EMA is responsible for evaluating and monitoring the safety of every pharmaceutical product that will supply the European Union. The EU cGMPs Eudralex documents dictate the requirements for manufacturing pharmaceuticals intended for usage in the EU.
• International Society of Pharmaceutical Engineers (ISPE): This not-for-profit group provides the pharmaceutical industry with frameworks that are widely used in the pharmaceutical industry. This includes the ISPE Baseline Guide and GAMP 5.

Additional regulatory and guidance organizations are:

• Pharmaceuticals and Medical Devices Agency (PMDA) 
• The International Conference of Harmonisation (ICH)
• The World Health Organization (WHO)
• The International Organization of Standardization (ISO).

CSV in pharma helps prove that the company’s computerized systems are abiding by the given regulations. It’s the responsibility of the CSV specialist to understand each applicable regulation for computerized system compliance. Also, they are to ensure the computer system validation is applied to any automated system applications at every step of the process to satisfy each requirement.

CSV specialists can be found throughout the pharmaceutical industry and may have different job titles, such as:

• CSV Lead
• CSV Engineer
• CSV Support Analyst
• CSV Subject Matter Expert
• CSV Specialist

Any computer system involved in the research, clinical testing, manufacturing, distribution, and storage processes must be validated by a CSV specialist. Some example computer systems are:

• Laboratory Information Management System (LIMS)
• Distributed Control System (DCS)
• Enterprise Resource Planning (ERP) Systems
• Laboratory Instrument Systems (LIS)
• Batch Record System
• Chromatography Data System (CDS)
• Clinical Trial Monitoring Systems
• PLC for Controlled Packaging Equipment
• Manufacturing Execution System (MES)
• Supervisory Control and Data Acquisition (SCADA)
• Building Management Systems (BMS)

A CSV specialist must test and document that the given system is reliably operating within accordance with applicable regulations. The aforementioned GAMP 5 process provides a framework for CSV specialists to analyze all of these different systems and more without needing to create a process for each system.

Qualifications for Becoming a Computer System Validation Specialist

To work in computer system validation in the pharma industry companies want applicants to demonstrate several qualifications, such as:

• An associate’s or bachelor's degree in a computer-related field, although many organizations will not accept an associate’s degree
• Excellent analytical and problem-solving skills
• Demonstrable writing and communication skills
• Able to work effectively on a team
• A Computer System Validation (CSV) certification

Anyone looking to become a CSV specialist will greatly benefit from a specific certification. CFPIE’s CSV course will take attendees from an introductory level to understanding the intricacies of GAMP 5 and other frameworks with a focus on meeting FDA regulations. 

Are you ready to receive the training you need to succeed as a CSV specialist? Sign up today for CFPIE’s Computer System Validation training course to gain the skills needed to succeed in your new role.