Validation and Compliance

PDF Download Prompt

Following the International Society for Blood Transfusion (ISBT) guidelines for Validation and Maintaining a Validated State, BC Solutions has developed a unique methodology that reduces the total validation testing time by 50% to 60%, or as much as 500 labor hours.

In our Operational Qualification (OQ) Validation, Transfusion or Donor software is validated against a set of User Requirement Specifications (URS) which describe the processes and safety checks expected from all Blood Bank or Donor software applications.

Using worst case scenario testing, we stress the system by targeting high risk areas that could potentially cause harm or injury to patients or donors if undetected.

The R.F. Nozick Validation

The R.F. Nozick OQ Validation Program was developed by a team of Blood Bank experts and laboratory clinicians who understood the need for an efficient system of validation that could save laboratories valuable time and resources while maintaining a high degree of patient safety. This program is what our company was founded on. Our passionate team of Blood Bank "Ninjas" are committed to providing an impartial third party validation because they know the importance of the work you do, and systems you rely on.

With the R.F. Nozick OQ Validation Program, you can rest assured you are audit ready and operationally safe for your patients.

Elements of the R.F. Nozick Validation:

System Review

Secure remote access allows us to evaluate our client’s system design while looking for inherent risks to patient safety.

Regulatory Requirements

By matching regulatory requirements (FDA, AABB, ISBT, EU, et al.) with system functionality, we not only ensure a compliant system, we also provide complete traceability in an easy to understand matrix that links the user requirements to the testing scenarios performed.

Risk Assessment

Each software function to be validated is evaluated by our team and subsequently rated as high, high-moderate, low-moderate, or low risk. The URS and risk assessment is subject to client approval prior to the start of validation and will guide the scope of the testing scenarios performed.

Test Plans

Client specific OQ test plans are developed by BCS subject matter experts. Test plans are designed to ensure all applicable high and high-moderate user requirements are validated.

Validation scripts are then executed by following very detailed test steps. System responses are evaluated by the implementer for adherence to user requirements and regulatory compliance.

Screen captures of the results are recorded, providing physical proof that the individual function has been validated. The screen capture files are permanent verifiable evidence of the test case performance and result.

Matrix Analysis & Validation Report

In addition to a formal final report, clients also receive our Matrix Analysis Document that links each requirement, test script, screen capture and test result in a clear format that makes it simple for an auditor to review.

The final report describes the validation process, strategy, results, and includes any problem forms generated because of non-conforming results. This report along with the Matrix Analysis is provided electronically (via secure, HIPAA compliant downloadable files) to our client.

PO Box 94568, Phoenix, AZ 85070

 (480) 346-7011 

Copyright © 2022 BC Solutions LLC | All rights reserved.  

BC Solutions is committed to the highest quality standards in all that we do.

We know that quality processes, people, and communication lead to the delivery of quality products and services. We have spent 25 years developing quality processes and services that deliver value and enhance patient safety in clinical laboratories.

Verified by MonsterInsights