A Guide for Computer System Validation needs

Introduction

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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 Good Practices (GxP), activities include:

• Manufacturing / Production (GMP)

• Clinics (GCP)

• Laboratory (GLP)

• Good Distribution Practices (GDP)

• Storage (GWP)

• Documentation (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.

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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

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

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

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This work is designed to be used regardless of their knowledge or experience related to validation or compliance with Good 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

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Through the principles and methodologies suggested here, this guide will help the organization to ensure that computer systems prove their fitness for intended use, meet the good practices of the industry in an efficient manner, provide 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 those who occupy this knowledge as part of their daily work and those who at some point will be involved in the effort 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.

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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.

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

Computer systems with GxP impact are becoming of particular importance today due to technological advances in process automation and data management and information generated by applications, and the increasing acceptance and use of these technologies in both administrative industrial, and productive processes.

As computer systems are increasingly integrated into many of the most important business processes, they help to reduce or eliminate the risks inherent in manual processes traditionally performed by qualified personnel. Thus, the risks of “human error” are no longer constant, while increasing the productivity and efficiency of processes does not depend on people performing repetitive tasks or require a high level of effort, leaving human hands to control tasks and maintenance of these systems, which provides room for creativity and process improvement.

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

Eventually, the growth of Artificial Intelligence (AI) integration into technology systems, mobile device interfaces, and the use of cloud-based systems presents new challenges for current validation schemes, which must demonstrate fitness for use and compliance with requirements at all times.

 

What is validation? What is a computerized system?

During the validation process of computerized systems, various stakeholders are belonging to parts of the company where the knowledge of issues related to validation, computer systems and information technology is usually not always the common factor. It is necessary to use common concepts to avoid subsequent misunderstandings or problems due to a lack of conceptual approval.