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A Complete Guide to Computer System Validation (CSV)

What is it and why do we need it?

If you wonder why needs a computer system validation, how the process looks like or you need some examples, have a look at this page.

Table of Contents

Introduction

This guide aims to suggest the tools and strategies necessary and appropriate for use in the validation of computerized systems for (human and veterinary) Pharmaceutical industries, Pharmaceutical chemicals (APIS and excipients), Biologics, Biotechnology, Blood Products, Gas Medicinal Products and medical Devices, used in activities related to compliance with Best Practices (BPx / GxP), activities include:

  • Manufacturing / Production (BPF / GMP)
  • Clinics (BPC / GCP)
  • Laboratory (BPL / GLP)
  • Good Distribution Practices (GDP)
  • Storage (BPA / GWP)
  • Documentation (BPD / GDP)

It provides a suitable approach to compliance with all types of computer systems, according to national and international regulations; based on the guidelines established in the GAMP® 5 Guide ISPE, providing an understanding of the logics of work, definition of scope and selection of the validation strategy that best suits the system to validate.

This Computer Systems Validation Guide is based on the following approaches:

  • Risk-based approach
  • Approach based on the life cycle of the system
  • Approach on “V” model for development and system test
  • Approach based on the process which serves the system
  • Approach on GAMP category system.

Throughout this guide a general review of the guidelines required for qualification identifying regulatory infrastructure base (NOM / FDA / WHO), prior to the validation of computer system requirement is performed.

It also identifies the documentary base to support the validation of computerized systems, in accordance with the particular QMS of each organization.

This work is designed to be used regardless of their knowledge or experience related to validation or compliance with Best Practices, among others, the following areas or business functions:

  • Administration
  • Quality Unit
  • Investigation
  • Development
  • Manufacturing
  • Laboratory
  • Engineering
  • Maintenance
  • Regulatory issues
  • Human Resources
  • IT
  • Support staff
  • associated suppliers

Through the principles and methodologies suggested here, this guide will help the organization to ensure that computer systems prove their fitness for intended use, meeting the good practices of the industry in an efficiently manner, providing practical guidance to facilitate the interpretation of regulatory requirements, with a language and terminology easy to understand and interpret, clarify the roles and responsibilities of each of those involved in the validation of computerized systems.

Finally, this guide is designed for understanding the principles of validation of computerized systems by the most diverse personnel, both who occupies this knowledge as part of their daily work and for those who at some point will be involved in the effort of to validate a system without any prior knowledge of Good Practices, validation or IT computer terminology, thus becomes a valuable tool for both and for anyone who wants to train others in basic and logical principles of work on Computer Systems Validation.

What do we need to validate?

Currently, the Health Industries such as pharmaceuticals (human and veterinary), pharmochemical, (APIS and excipients), Biologics, Biotechnology, blood products, and medical devices, are required to establish a validation program to demonstrate that any procedure, process, equipment, material, activity or system actually leads to the expected results.

Must be validated the computerized systems that have an impact on product quality, impact on patient health, and good practices (BPx, as in the case of those who serve production processes, storage of inputs and finished products, insurance quality, documentation management, electronic records, etc.), in order to meet normatively, ensure the integrity and traceability of information and product quality.

Today, computer systems with GxP impact take on special importance due to technological advances in process automation and data management and information generated through applications and the increasing acceptance and use of these technologies in both administrative industrial processes as productive.

Being increasingly integrated into many of the key business processes, computer systems help reduce or eliminate risks inherent to manual processes traditionally carried out by qualified personnel. Thus, the risks of “human error” are no longer constant, besides raising process productivity and efficiency does not depend on people to perform repetitive tasks or require a high level of effort, leaving human hands to control tasks and maintenance of these systems, giving room for creativity and process improvement.

With the above, it should be emphasized that the use of computer systems not completely replace the human factor, rather it potentiates, raises its level within the process, whereby human error still exists, but at another level. Equipment and systems still rely on humans to tell them “what should do” and “how they must do” and any human error in this part results in an error in the rest of the process. There´s a phrase that says “The machines does not commit a mistake, but the humans do it” thus wrong instructions will result in erroneous results, is for this reason that the human factor is decisive in validating, from defining its responsibilities, through the training and qualification of personnel.

Eventually, the growth of Artificial Intelligence (AI) integration on technology systems, interfaces with mobile devices and the use of cloud-based systems is assuming new challenges for current validation schemes seeking to demonstrate at all times suitability for use and compliance of requirements.

What is validation? What is a Computerized system?

Since during the Computerized systems validation process exist various stakeholders belonging to areas of the company where usually the knowledge on issues of validation, computer systems and information technology is not always the common factor, it is necessary to handle common concepts to avoid subsequent misunderstandings or problems arising from a lack of conceptual approval.

The following table lists some validation definitions according to regulations and national and international guidelines as follows:

Definition of Validation

NOM-059-SSA1-2015

“Documentary evidence generated through the collection and scientific evaluation of the data obtained in qualifying and specific tests throughout the entire life cycle of a product, which aims to demonstrate the functionality, consistency and robustness of a given process in their ability to deliver a quality product. “

Food and Drug Administration (FDA)

“Validation is the confirmation by objective evidence, that the requirements previously established for the use of a process or system are met.”

WHO guidance on the requirements of good manufacturing practices (GMP)

“Establishment of documentary evidence that provide a high degree of assurance that a planned process will be uniformly in accordance with the expected specified results “.

 The above definitions have in common the following elements: 

  • Generating evidence
  • Compliance of requirements
  • In accordance with expected results 

The definitions that handle national and international standards and guidelines for computer system must include: 

Definitions computerized / Computer System

NOM-059-SSA1-2015

“Computer / computer system, any equipment, process or operation having one or more computers coupled and associated software or a group of hardware components designed and assembled to perform a specific functions group”.

Food and Drug Administration (FDA)

“Functional unit of one or more computers and input and output devices, peripherals and associated software, uses common for all or part of a program and storing all or part of the data necessary for program execution”.

GAMP® 5 ISPE 

“System containing one or more computers and associated software, network components, functions controlled by them and associated documentation”.

Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (ICH7) “Computer system: hardware components and associated software, appointed and assembled to perform a specific function or group of functions.” “Computer system: process or operation integrated with a computer system”.

ANSI

A functional unit, consisting of one or more computers and associated peripheral input and output devices, and associated software, that uses common storage for all or part of a program and also for all or part of the data necessary for the execution of the program; execute user-written or user-designated programs; performs user-designated data manipulation, including arithmetic operations and logic operations; and that can execute programs that modify themselves during their execution. A computer system may be a stand-alone unit or may consist of several interconnected units.

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