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