Regulatory Validation
Transfusion & Donor Systems
Independent Validation
Our team has been performing validations on every major blood bank computer system for over 25 years. Our process is designed to save you time. We perform all validation related activities and provide detailed regulatory compliant documentation for your review. Our final report is designed for simple review with your team, directors, and auditors.
Clear, thorough, and compliant. Just like your team. Experience matters. Change doesn’t have to be a Challenge.
Risk Assessment
User Requirements
Customized Plans
How we work:
We work remotely with little impact on your daily activities. Our priorities are quality, compliance and patient safety, but we also understand that our work is just a small piece of what makes your laboratory run.
That’s why we provide:
- Documentation that is thorough and easy to review.
- Open documents that can be reused, or used for training.
- Support for code version validation.
Whether you use BC Solutions to perform OQ validation, prevalida on review and testing or work with our Consultants to test workflows and interfaces, or rely on us to support your ongoing Compliance Program, we are committed to finding the solution that works for your team.
Your patients, donors, and clients expect personal care from you.
Our clients expect the same from us.
Validation and Compliance
Blood bank OQ Validation (Operational Qualification) of your system. Whether you’re taking an upgrade or are planning a new build, BCS has built our reputation on our validation process and documentation.
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.