BC Solutions

Following the ISBT Guidelines for Validation and Maintaining a Validated State, we have developed a methodology that reduces the total validation testing time by 50% to 60%, or as much as 500 hours.  We stress the systems as you would, targeting high risk areas looking for problems that could injure a patient if undetected.  With a RF Nozck Validation, you can rest assure you are audit ready and safe.

System Review

Looking for inherent risk, an analyst accesses the client's systems via VPN to evaluate the system design.

Regulatory Requirements

Our analyst matches appropriate regulatory requirements (FDA, AABB, ISBT, EU, etc.) with system functionality to insure the validation process is in compliance to local, national, and international regulations.

Risk Assessment

A risk assesment is created for each function to be validated. They are labeled as high, high-moderate, low-moderate, or low. The risk assessment is approved by the client.

Test Plans

Operational Qualification test plans are developed to validate all high and high-moderate risk items. The test plans are designed to stress the system to insure all identified risks are mitigated. All test plans are approved by the project manager prior to implementation.

Test Plan Implementation

Following the development of test plans, analysts implement the plans and record the results using Snag-IT software. Snag-IT is used to take a screen shot of each result. The screen shots are stored as verifiable evidence of the result.

Matrix Analysis

Documentation that links each requirement, test script, and associated risk.

Validation Report

A formal report describing the validation process, strategy, results, and problem forms for all non-conforming results. An electronic copy is provided to the client.