Validation Tool Kit: Become Self-Sufficient

BPA provides a comprehensive package that has everything you need to perform computer system validations. On-site training, easy-to-use procedures and templates, a detailed how-to manual, and coaching through your first validation combine to provide a complete set of tools and knowledge for efficiently conducting validations of software used in production and quality systems. Such validations are required by the Quality System Regulation (212 CFR 820 70i) and ISO 13485 (7.5.2.1).

Contact Tim Stein at (408) 366-0848 or by e-mail.

Part 1: “Validating Computer Systems for Business Applications” RiskVal ^(SM) Training

This two-day on-site workshop focuses on the validation process and the creation of the validation deliverables. This is a participative workshop designed to get you started validating your systems. The participants apply the concepts to their systems in small teams under the guidance of the trainer.

Participants learn a process for meeting the regulatory requirements for software validation, ensuring quality in business applications, and managing the risks associated with potential system failures. Guidance is provided on how to save time and money in the validation based on the risks associated with failure. Emphasis is placed on the common deliverables for computer system validation efforts such as requirements, validation plan, vendor qualification, risk assessment, test protocols, and protocol reports. Real-life examples are used to illustrate the process. The need for computer system validation is established from both a business and regulatory perspective.

Part 2: Procedures and Templates

The documentation provides the procedures needed to meet the QSR, Part 11, and ISO 13485:2003 requirements for a defined validation process. Templates for the most commonly created deliverables from the validation process are also included. The extensive instructions and examples provided by the templates streamline the task of creating validation deliverables. You will receive Word files of the following:

• Validation Policy
• Lifecycle for the Selection, Implementation, Validation and Use of Off-the-Shelf Computer Systems
• Requirements for Computer System Requirements, Validation Plans, Protocols, and Reports
• Computer System Risk Evaluation for Determining Risk Mitigations, Validation Activities, and the Extent of Testing
• Change Control for Validated Systems
• Computer System Project Proposal
• Computer System Vendor Qualification and Management
• Guidance: Items to Evaluate in an IQ, OQ, or PQ for a Computer System
• Guidance – Validation Activities for Systems at the Low-, Moderate, and High Risk Levels
• Validation Plan Template for Single Validations
• Computer System Technical Requirements Template
• Computer System Specification Template
• IQ Template
• OQ Template
• PQ Template
• Validation Final Report Template
• IT Policy

These documents are also available separately on this web site.

Part 3: How-to Manual

The Computer System Risk Management and Validation Life Cycle, 2006 Paton Professional, is a hands-on and comprehensive manual for computer system validation. Easily understood by system users, QA and IT professionals, this book simplifies the validation of a wide range of systems through a clear presentation of fundamental principles, and provides specific guidelines on how to save time and money through a risk-based approach. A case study follows the text and illustrates how one company used the RiskVal Life Cycle^(SM) to implement and validate a system that meets regulatory requirements. Thirty-three outlines of deliverables, methods, and processes transform jargon into actionable tasks. Deliverables are mapped to FDA and European guidance documents. The author integrates validation, risk management, and system implementation into a single, easy-to-use process called RiskVal. The RiskVal Life Cycle is applicable to all industries where computer systems pose a substantial risk to business continuity, efficiency, and the integrity of high-value data.

Click here for more on this book.

Optional Part 4: Support with One Validation

BPA can guide you through your first validation. The specific services provided are determined on a case by case basis.

Tim Stein, the Author, Trainer, and Consultant

These tools were developed by Tim Stein, BPA’s Founder and CEO. Tim is recognized internationally for his expertise in computer system validation and quality systems. He is the author of the book and the documents; he personally conducts the workshop, and will guide you during your first validation. All aspects of the tool kit are consistent with the RiskVal Life Cycle^(SM) which Tim has developed.

Benefits

The BPA tool kit provides the knowledge you need to validate computer systems using a consistent methodology that meets FDA requirements. The risk-based process and time-saving templates will increase your efficiency. Using this tool kit will enable you to validate your own systems at a fraction of the cost of hiring outside consultants.

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

Contact Us
Call Tim Stein at 408-366-0848