Validation Framework and Data Integrity Program for CGT Non-Profit Organization

science-7788808_1280 (1)

A Non-Profit Organization creating cell and gene therapies was looking to improve their CSV, CQV, and data integrity program.

The Brevitas team stepped up and provided Training, Standard Operating Procedures, and Data Integrity tools to help our client improve their Data Integrity Program and implement appropriate remediation actions.

Industry

Cell and Gene Therapy

Area of Expertise

Computer System Validation, Data Integrity & Training

Duration

4 months

Services Provided

  • Data Integrity Assessment Tool
  • CSV and Data Integrity Training
  • Lifecycle Validation Development

Impact

Developed a Data Integrity Program involving applicable SOPs and an Assessment Tool for our Client to identify gaps within their systems.

Business Challenge

A non-profit organization creating cell and gene therapies was looking to improve their CSV, CQV, and data integrity program. Moving from research and clinical trials to personalize production, raised a concern with our client with respect to data integrity and compliance within their manufacturing process. The project involved development of data integrity tools and appropriate governing procedures.

Our Approach

At the start of the project, we established the client’s baseline understanding around CSV and Data Integrity. Once we gained an appropriate understanding, we worked with the client to identify the high-risk systems, equipment, and processes involving data integrity. We developed a data integrity assessment tool in which we performed the execution of one system utilizing this tool. We trained our client in using this tool and supported them during the data integrity assessment for their other systems. This tool helps to identify the DI gaps in their systems and documents the remediation actions required for compliance. Lastly, we supported the development of CQV, CSV and DI SOPs to help create an overarching validation program.

Results Achieved

From inception to completion, the Brevitas team contributed to the success of the project by providing the following services and deliverables:

  • Development of DI Program
    • DI SOP
    • Data Integrity Assessment Tool
    • Training on Data Integrity
  • CQV SOP
  • CSV SOP
  • Vendor Questionnaire

More Case Studies

Untitled design (25)

Airflow Visualization Study to address audit observations

science-7788808_1280 (1)

Validation Framework and Data Integrity Program for CGT Non-Profit Organization

Serialization and Aggregation Project

Serialization and Aggregation Readiness for US Products

GMP Drug Manufacturing

GMP Drug Manufacturing Policy Development

Data Integrity Risk Assessment

FT-IR Instrument Data Integrity Risk Assessment

Autoclave Validation

Autoclave Qualification to Achieve Regulatory Compliance

logistics transportation services

Sortation Code Upgrade Enhances Sortation Functionality & Efficiency

SOp consolidation

SOP Consolidation across Multiple Global Sites Promotes Move towards Lean Operations

Let's Get Started!

Our expert consultants will guide you step-by-step through the process of achieving tangible results and long-lasting improvements.