Computer System Validation and Risk Management Services

The RiskVal Life Cycle ^(SM) = Validation and/or Risk Management
Results achieved by the RiskVal Life Cycle ^(SM)
RiskVal Services ^(SM) Approaches
RiskVal Life Cycle ^(SM) Phases

The RiskVal Life Cycle ^(SM) = Validation and/or Risk Management

The “RiskVal Life Cycle” ^(SM) is the name given to the process for computer system risk management and validation developed by Tim Stein, BPA’s founder and president. It is a process that simultaneously manages the risks associate with computer system failures and validates that the system will function satisfactorily over the anticipated operating range. It is an integration of state-of-the-art computer system validation and computer system implementation methods with risk management practices described in ISO 14971. Companies just interested in validation will find the Life Cycle well suited for that purpose. A “how to” guide to the Life Cycle is described in detail in Computer System Risk Management and Validation Life Cycle, Paton Professional, 2006, written by Tim Stein.

The RiskVal Life Cycle ^(SM) meets the American Food and Drug Administration's, the European Union's, and the ISO 13485 requirements for computer system validation.

The nine phases of the RiskVal Life Cycle ^(SM) are presented below.

Results Achieved by the RiskVal Life Cycle ^(SM)

The following outcomes are anticipated through the use of the RiskVal Life Cycle ^(SM).

• Meeting the computer system validation requirements of the American FDA, the European Union, and ISO 13485
• Saving time and money during the validation by using a risk-based approach
• Selecting a system that meets the organization's needs and requirements
• Controlling the risks asociated with computer system failure
• Confidence that the system will function as intended across the full range of its use

RiskVal Services ^(SM) Approaches

BPA can implement the RiskVal Life Cycle ^(SM) for you (i.e., perform validations and/or risk management for you), transfer knowledge and skill to your organization, or provide selective services to support you in validating and/or managing risks associate with your systems.

The RiskVal Services ^(SM) are described below from three approaches. These approaches can be combined, or different approaches can be used for different projects within the same organization.

• Approach 1 – We Perform the Validation and/or Risk Management for You
• Approach 2 – We Enable You to Perform Validations and to Manage Computer System Risk Through Training and the Establishment of Policies and Procedures
• Approach 3 – Limited Support on Specific Projects

Call Tim Stein to determine which approach will best meet your needs (408-366-0848) or send an e-mail.

Approach 1 – We Perform the Validation and/or Risk Management for You

We can execute any, or all three, of the major dimensions of the RiskVal Life Cycle ^(SM):

• Validation
• Risk management
• System implementation

Having BPA implement the RiskVal Life Cycle ^(SM) for you has the following benefits:

• Your validations will be defensible to regulators
• The cost of the services will be dependent on the level of risk associated with potential system failures
• The implementation will be performed by, or under the direction, of the person who developed the RiskVal Life Cycle ^(SM), Tim Stein

Approach 2 – We Enable You to Perform Validations and to Manage Computer Risk Through Training and the Establishment of Policies and Procedures

For those organizations that want to validate their systems and/or manage computer system risks themselves, we will transfer the required skills and help you put in place the policies and procedures that you need. This approach has four benefits:

• Your validations will be defensible to regulators
• Your staff will become self sufficient in performing validations and managing the risks of computer system failure
• Validations will cost a fraction of what you would pay to have an outside firm do the validation
• You can leverage the limited money you have available by spending it on the support that is needed the most to ensure a defensible validation and protection against computer system failure

These services can include:

• Training on how to use the RiskVal Life Cycle ^(SM). On-site training includes work sessions during which your employees apply the RiskVal ^(SM) concepts to your systems
• Establishing the necessary policies and procedures, or licensing the use of BPA’s policy and procedure documentation, and deliverable templates
• Providing templates for deliverables
• Preparing a validation master plan

A “Starter Package” is available that includes training and the basic policies, procedures, and templates needed to perform validations

Approach 3 – Limited Support on Specific Projects

The third approach is designed for companies that have limited dollars for validation and want to do most of the work themselves. Guidance from BPA and perhaps help in preparing some of the deliverables can have the following benefits:

• Save you money
• Provide you with the confidence that your validation will be defensible to regulatory bodies
• Provide the right amount and type of resources you need to work with your staff

Our services will be tailored to your needs and budget. Such support could include, for example, creating selected deliverables with your staff, such as a risk analysis, validation plan, or protocols, or our playing an advisory and review role during the entire risk management and validation process, or simply our auditing a validation that you have conducted.

Call Tim Stein at BPA to find out how we can help (408-366-0848) or send and e-mail.

RiskVal Life Cycle ^(SM) Phases

The RiskVal Life Cycle ^(SM) includes nine phases:

1. Conceptualize – understand the need for a system and some initial investigation to determine the type of system needed
2. Define Requirements – define user and technical requirements for the system, and business requirements for the vendors
3. Select Vendors and Systems – evaluate the goodness of fit of alternatives to the requirements, and select and contract with vendors
4. Design Solutions to Issues – issues include requirements that are not met, failure to comply with regulations, and risks that are too high
5. Construct Solutions to Issues – implement solutions and evaluate their effectiveness
6. Prepare for Use – prepare the system for use and the organization to use it
7. Qualify the System – perform tests on the system in your environment and obtain objective evidence that it is able to meet your requirements
8. Use in a Production Environment – use the system in a controlled manner so as to not introduce changes that cause the system to fail
9. Retire the System – retire the system and preserve access to past data and records

For more information on the RiskVal Life Cycle ^(SM) and RiskVal Services ^(SM), contact Tim by e-mail, or phone (408-366-0848).

For more information on the book Computer System Risk Management and Validation Life Cycle, or to place an order, click on the title.

“RiskVal,” “RiskVal Services,” and “RiskVal Life Cycle” are service marks owned by R. Timothy Stein.

Contact Us
Call Tim Stein at 408-366-0848