Software Validation in the Pharma Industry

CSV (Computer System Validation) is the process of ensuring that any hardware or software technology component is fulfilling its purpose in line with the regulatory guidelines for a certain industry. CSV is especially critical in industries that have to follow strict FDA guidelines such as pharmaceutical or biotech sector since products from these sectors impact the health and safety of its consumers significantly.

Advantages of Software Validation

Software validationis critical for ensuring pharmaceutical cGMP as the software may be embedded in important clinical tests. Some advantages include:

  • It helps in mapping the product development to customer requirement, thus ensuring that the software functionality is accurate
  • It helps in identifying various defects that the employees might have missed during the verification phase
  • It is an integral part of the quality assurance process as it assures compliance with various stringent pharmaceutical manufacturing standards
  • It is carried out during the testing stage as part of good manufacturing practices (GMP) since it is done during stages like stress testing, load testing, etc.

Equipment validation ranks high on importance in any vertical of the pharmaceutical industry, therefore you must ensure that the ‘software part’ isn’t neglected at any stage.

Software Development Life Cycle

The Software Development Life Cycle (SDLC) is a step-by-step process for developing software and consists of the following 10 steps:

  1. Requirement Analysis

The first step to software development is to capture and document the user requirement.

  1. Feasibility

The feasibility study involves creating a draft plan of the software and analyzing the techno-commercial viability of the project.

  1. System Analysis

This step involves evaluating the pros and cons, outlining the scope of the work and planning resources.

  1. Software Design

The process of software design helps in preparing the blueprint of the project and involves creating the logical and physical design.

  1. Coding

This is the core technical stage that identifies programming in a suitably identified language.

  1. Testing

If there are any bugs in the code, it is addressed in the testing stage where the bugs are identified and removed.

  1. Integration

Integration helps with aligning the software with other entities such as databases, libraries, etc.

  1. Implementation

This rollout phase involves the installation of software on end-user machines.

  1. O&M

It is a real-time process that keeps the software running.

  1. Revisions and Disposal

Based on the performance of the software and its changing needs, you might have to upgrade it with a revised version or completely scrap it if it’s obsolete.

Relation Between CSV and SDLC

CSV is very closely interlinked with SDLC considering it is conducted at every stage of SDLC. CSV is a part of the testing process that has one key differentiation of validation at each step rather than a single final stage testing. In fact, the CSV process is created keeping in the mind the steps of SDLC and is roughly modeled as per an archaic model of the same.

The entire process of CSV also adheres to several FDA guidelines that are defined for the pharmaceutical industry in order to meet the quality standards and conform to pharmaceutical cGMP. We can say that the FDA guidelines create the framework for CSV and constantly define the way it is shaped and remodeled over time, based on various dynamic forces in the pharmaceutical industry.

The various forms of testing and related activities that need to be performed at every step of SDLC are mainly classified in two ways:

Static Testing: This includes all the analysis and review activities that can be conducted without having to execute the software. Examples include inspections and walk-throughs.

Dynamic Testing: This includes review/analysis activities that are conducted after the software is executed, and compares its performance against the expected results.

How is CSV an Integral Part of FDA

Computer system validation has become an important part of FDA compliance regulations for every pharma company. If you fail to include proper CSV in your validation program, it may lead to warning letters and inspectional observations from the FDA. Furthermore, if you don’t take any corrective action in time after a regulatory inspection, you will be faced with heavy fines, legal proceedings, and sometime even worse – like discontinuing the manufacturing of the product or shutting down the company altogether.

Prioritize pharmaceutical validationin your facility to ensure high accuracy and quality of products and services.

Author Bio: Edward Simpson works for RS Calibration Services and has a knack for finding faults in machines and does not rest until they are rectified to perfection. He lives in Pleasanton, CA and loves to write about how machines work and about the importance of proper care and calibration of equipment. When he’s not working or writing, he loves to run to stay fit.

Steven Anderson

About Steven Anderson

Steven has over 10 years of experience in online media industry at various positions throughout the editorial cycle. Because of his interest in presenting scientific knowledge to the general public as well as providing a platform for information dissemination, Steven decided to bring together a team of like-minded individuals and started Healthcare Trends. You can find his contact details here.

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