Chapter 4. Establish Team(s)

Introduction

This chapter looks at establishing the System Validation Steering Team and the System Validation Team. This is the first step in the validation process.

Note: The names of these teams may vary according to the preference of the site. For the purposes of standardization, this document will always use the above names.

Validation Protocol

The way in which the members of these teams fit into the organization and their responsibilities should be documented in the Validation Protocol.

Relationship to Validation Committee

Chapter 2 described the formation of a Validation Committee. The System Validation Steering Teams and the System Validation Teams within a site or department can be positioned as follows:

Existing system

The organizational structure for the validation of an existing system is the same as for a new system. If the system is already installed and validation is required, then the System Validation Steering Team and the System Validation Team may be formed at that time.

Introduction

This topic looks at the System Validation Steering Team. The System Validation Steering Team oversees a specific computer system validation.

Team members

The System Validation Steering Team should be made up of representatives from:

·         Quality Assurance

·         Information Resources

·         Department in which the system is used

·         Group managing the project (if different from the user department)

Note: For small systems, the Validation Steering Team may be the same as the Validation Committee (See, Chapter 2 - Before You Start the Validation Process)

Responsibilities

The responsibilities of the System Validation Steering Team include, but are not necessarily limited to:

·         overseeing activities for a specific computer system validation

·         ensuring the Validation Protocol is created (either by members of the System Validation Steering Team or the System Validation Team)

·         approving the Validation Protocol

·         establishing the System Validation Team

·         holding regular project meetings at predefined intervals

·         preparing the Validation Report

·         certifying validation results

·         establishing a periodic review, and if necessary, revalidation, for the system

Experts

The System Validation Steering Team may rely on the opinion of experts within the System Validation Team when they certify the validation.

Consultants

Consultants may be engaged if there are insufficient resources and expertise in the System Validation Team or the System Validation Steering Team or both.

Consultants would normally be requested by the System Validation Steering Team and approved by the Validation Committee (See, Chapter 2 - Before You Start the Validation Process).

A request to engage a consultant must include a detailed documented review of the prospective consultant’s capabilities. Before engagement, a contract specifying scope, roles and responsibilities must be signed.

Introduction

This topic looks at the System Validation Team. The System Validation Team performs the validation tasks for a specific system.

Team members

The System Validation Team composition should reflect the requirements of the validation. This will vary according to the type of system in question.

The System Validation Team should be made up of representatives from:

·         Department in which the system is used

·         Information Resources

·         a User or Technical level (someone who is familiar with the system)

·         Problems and issues should be raised with the System Validation Steering Team

Note

The System Validation Team will be guided by the System Validation Steering Team.

Training

The System Validation Team should receive additional (documented) training as appropriate to the validation being performed. This will ensure that they have the required skills.

Responsibilities

The responsibilities of the System Validation Team include, but are not necessarily limited to:

·         identifying the required validation/qualification activities i.e. prepare validation plan

·         preparing the qualification protocols

·         performing the validation/qualification activities

·         collating, indexing and filing validation/qualification documentation

·         preparing the Validation/Qualification reports