CASE STUDY

A privately held biotechnology company developing transformative cell therapies needed to build the technology foundation to be IT, Quality and Computerized Systems compliant. Goals included: 

Data Analytics

OBJECTIVE

A privately held biotechnology company developing transformative cell therapies needed to build the technology foundation to be IT, Quality and Computerized Systems compliant. Goals included: 

Assessing  and Developing Policies & Procedures / Selecting and Implementing  QMS /  Applying a Risk-based Approach to Validation (CSA Concepts) / Maintaining a Compliant Environment   

SOLUTION

  • Vendor used the V Model for Validation (i.e., an extension of the waterfall validation model) and  based testing on each corresponding development stage. The execution of processes was performed in a sequential manner in V-shape (Verification and Validation model inverted V validation methodology). 
  • The Platform Application was designed with regulated system compliance in mind and​ included robust document, object, system and user audit trails in accordance with industry guidance, such as 21 CFR Part 11.​
  • Agile methodology was used for software development, code reviews and updates. ….​
  • Vendor performed IQ and OQ and pre-qualified PQ. Company performed PQ, which was minimal and leveraged Vendor’s Validation Documentation package. Company performed the PQ testing.​

RESULTS

  • Platform as a Service (PaaS) Integrated Solution – Cost-Effective for IT & Quality ​
  • Client’s ability to begin operations as a complaint, stand-alone, Independent Company
  • Client was able to maintain a validated state for all controlled documentation
  • Improved systems benefiting business users
  • Project aligned with the individual system’s regulatory and business risk and the Health Authorities’ expectations and guidance  

Key Project Elements

Assess  and identify gaps in IT and Quality

Apply Risk-based approach to Validation

Leverage Vendor’s IQ and OQ documents and Pre-Qualified PQ

Result: Time and Costs were reduced​ Validation and Testing were streamlined and minimized​​