Computerized Systems Validation Team

We´ll analyze the steps and requirements necessary to create a computerized system validation team in industries that operate in regulated environments.

Validation projects of computerized systems in regulated industries – such as pharmaceutical, cosmetics, health products, or the food industry – require a multidisciplinary team to gather the necessary expertise to coordinate the areas of Processes, Software, IT Infrastructure, the company´s Quality System and the regulatory requirements. And it is essential the support of the Management in the IT strategic line to follow.

Many regulatory agencies already expect that activities of the Quality System – including the validation of facilities, systems, and processes – will be supported in practice by multidisciplinary teams.

This is because, increasingly, the quality results depend on the creation of these multifunctional teams that allow us to adequately manage the capacities, motivations, and limitations of each area and guide all people towards the same goal.

Therefore, we will analyze how to create a computerized systems validation team to guide the planning of this type of project and to help determine who should be part of the ream based on the proposed objectives.

Create a validation team for computerized systems in regulated environments

Finding, evaluating and securing the right talent to create a computerized systems validation team in industries that operate in regulated environments can be a challenge.

Next, we will explain the steps to achieve it.

1 Determine the scope of the validation team

At first, it is necessary to determine the functional areas that need to be controlled, the processes and systems involved and the experience required of the people who will implement the identified controls.

A guide to determine these criteria is the following:

Internal operations

It is necessary to determine if and to what extent the validation project requires specialized experience in the internal processes or on the equipment that carries them out.

It is convenient to identify which specific operations require technical support. And what skills or experience are essential to guarantee internal operations.

Specific product requirements

It is necessary to determine all the relevant requirements related to the product and equipment on which the people belonging to the validation team must have experience.

Environmental requirements

Similar to the product requirements, it is necessary to determine if the project requires the validation team to operate in a restricted environment if a level of experience is required and if it is still critical, it may be beneficial for the project.

Computerized Systems

Some validation projects may require specialists in certain systems. It is necessary to determine if there are specific equipment to be validated and what are the internal requirements for the computerized system.

And it is also important to consider what specific skills, training, and experience the validation team must include conducting exhaustive reviews.

Documentation and regulatory requirements

If the project involves the drafting of GMP-compatible documentation and the generation of new procedures, the validation team must be able to produce documentation that complies with the internal SOPs and external regulations.

Likewise, it is necessary to determine the level of experience of the validation team to generate the necessary documentation, manage the internal document control system, create new clear and easy to follow procedures and promote controls on the changes applied.

2 Determine the roles and responsibilities of the team

The next step to create a computerized systems validation team is to determine the roles and responsibilities and the level of multifunctional integration needed.

The essential tasks are usually to define internal procedures, evaluate risks, document, review and approve validation activities. In addition to carrying out the validation work itself, the tasks of the validation team are also to inform the project, document its planning and control, approve the validation procedures, monitor the functioning of the computerized systems and train other people.

In the following tables, you can review a detailed example of the roles, responsibilities of each role and skills/experience required to create a computerized system validation team.

Director
Description of the role within the team:	Approve the Validation plan Allocation of resources for the fulfillment of the plan (human and economic) Ensure team training Determine that the procedures must exist and must comply Monitoring of validation results
Staff of [client company] assigned to this role:	[name and surname], such as Pharmaceutical Technical Director

Leader
Description of the role within the team:	Monitoring of the strategy and validation plan Communication of plan compliance to the director Communication of results to the director Coordinates the team and their tasks Coordinates the working groups and ensures their training for the project Follow-up- control of established procedures Compliance monitoring plan Monitoring results Resolution of incidents / conflicts, decision making
Skills and knowledge:	Organized, able to perform multiple tasks Team management Detail oriented Technical knowledge needed Effective time management Good communication
Staff of [client company] assigned to this role:	[name and surname], such as IT manager

Process representative
Description of the role within the team:	Responsible for the process Knowledge of URS (User Requirements Specification) Knowledge of SOPs (Standard Operating Procedure) Generates and reviews system documentation Verify that the system is suitable for URS, regulations and SOPs
Skills and knowledge:	Knowledge of the processes Knowledge of URS Knowledge of SOPs
Staff of [client company] assigned to this role:	[name and surname]

Representative of quality guarantee
Description of the role within the team:	Knowledge of functionalities, configuration and software registration Knowledge of software security Determine possible risks of the software in the management of the process Knowledge of the architecture and implemented control system (formed by the different implanted software) Technical knowledge
Skills and knowledge:	Ability to ensure that processes and procedures are met Good understanding of validation and documentation processes
Staff of [client company] assigned to this role:	[name and surname]

Software representative
Description of the role within the team:	Knowledge of functionalities, configuration and software registration Knowledge of software security Determine possible risks of the software in the management of the process Knowledge of the architecture and implemented control system (formed by the different implanted software) Technical knowledge
Skills and knowledge:	Total knowledge of the software: configuration, functionalities, registers, interfaces, security, etc. Technical knowledge needed Knowledge of regulations Change management capacity
Staff of [client company] assigned to this role:	[name and surname]

IT Infrastructure representative
Description of the role within the team:	Knowledge of IT infrastructure Maintenance management Manage user access and privileges Determine possible risks of the infrastructure in the support of computerized systems Generates and reviews system documentation
Skills and knowledge:	Total knowledge of infrastructure Knowledge of regulations Change management capacity
Staff of [client company] assigned to this role:	[name and surname]

It should be noted that this definition of profiles of the validation team complies and is based on version 5 of the GAMP (Good Automated Manufacturing Practice) guide, published by the ISPE International Society for Pharmaceutical Engineering.

In this phase, it is necessary to define in detail who will be the members of the validation team as well as if there are areas in which an external specialist is required.

3 Determine which areas external specialists are required and what skills, experience, and knowledge are necessary

De acuerdo con los roles, las responsabilidades, los conocimientos y las habilidades propuestas en el ítem anterior, se pueden establecer brechas o áreas en las que se presentan deficiencias que no pueden ser suplidas por el personal interno. De modo que surge la necesidad de incorporar especialistas externos.

According to the roles, responsibilities, knowledge, and skills proposed in the previous item, gaps or areas can be established in which deficiencies that cannot be met by the internal personal are presented. So, the need arises to incorporate external specialists.

If that is the case, the following questions must be resolved:

• What team operations need support, and what skills, abilities or experience are required?
• What specific requirements exist for the product or project, and what kind of capabilities will external specialists require?
• Will documentation skills be needed?
• With what specifications will external personnel need to work to perform evaluations?
• Are there specific systems with which you should be familiar?

In a computerized validation project, it is important to have the support of an organization that can provide personnel with experience in the sector in which it operates.

4 Create a plan so that the milestones of the validation project are met

One of the biggest challenges, when creating a computerized systems validation team is to maintain a total commitment to the calendar. Frequent and planned communication, throughout each phase, is an effective strategy to keep the project moving. And it is also necessary to ensure that the data flow as they should, among the activities of the process, thus preventing it from stopping.

It is also important to determine the mechanisms that the team will use to manage the flow of data from one activity to another, and ensure that it is well established from the beginning of the project.

In this phase, it is key:

• Establish the milestones of the project and from them perform rapid assessments of the status of the projects.
• Include a risk analysis for review carried out.
• Design an effective communication plan, on the progress of the project routinely.
• Perform process audits during critical milestones.

The value of having external support in the validation

Carrying out effective validation projects throughout the life cycle of the product – from research and development to production and distribution – continues to be an important challenge for companies in regulated sectors.

Having the expertise and experience of external consultants allows not only to fill internal gaps but also to increase efficiency and ensure a positive outcome of the project.

At Oqotech we have the experience and expertise to provide technical and personal support for your computerized systems validation projects. Contact us and receive personalized information from one of our consultants.