CSV Project Support - Facility Start-Up

Client: Vor Biopharma (Cambridge, MA)

Project Scope

In 2020, the client took occupancy of a newly fit-out 32,000 SF lab/office space. In support of operational readiness initiatives, Mission BPS was selected to help establish and implement the site's System Development Lifecycle (SDLC) roadmap, subsequently leading GAMP-5 and CSA-compliant deployment of numerous GMP-critical applications, including CMMS, EMS, MES, ERP, and eQMS solutions.

Dynamic Strategies

As the scope of software solutions ranged from configured hardware/infrastructure (GAMP Cat.1) to configured applications (GAMP Cat.4), each deployment project required a unique risk-based approach for implementation and subsequent change management.

GAMP Category 1 Systems: Where systems consisted of in-house infrastructure and/or Infrastructure as a Service (IaaS), consolidated planning and design phase deliverables (such as an all-encompassing Functional & Design Specification document) were developed and risk-assessed to yield both a basis of design and a basis of test scope in a streamlined effort. The scope of subsequent testing, in many cases, was reduced to the verification of complex configuration attributes.

GAMP Category 4 Systems: With (SaaS) platforms, particularly those custom tailored to suit the client's business processes, a more traditional GAMP-V model was employed, though it was less efficient in comparison. In such cases, efficiency was gained by emphasizing more robust front-end risk assessment strategies (per CSA guidance) to (a) firmly identify configured attributes of higher complexity/probability of misconfiguration and (b) adopt the efficiency of unscripted testing processes for lower risk out-of-box/standard functionality.

Project Outcome

From Q4 2020 through Q1 2024, I supported the configuration, qualification, and deployment of nine platforms:

• CMMS: BMRAM R4 Cloud

• EMS: Schneider Electric EcoStruxure

• MES: POMSnet Aquila MES

• GxP Data Management: TetraScience / Tetra Data Platform

• QMS: IQVIA SmartSolve, Veeva Vault Doc and Training

• ERP: Oracle Fusion Cloud – Supply Chain Management

• Clinical Data Transmission: Custom Solution on AWS cloud infrastructure

• GMP Data Management: Tetra Science TDP

• Paperless Validation & Change Management: Sware Res_Q

For each platform, I authored plan, design, test, and deployment deliverables through both on-site and remote collaboration, maintaining open communication with all stakeholders - ensuring seamless execution of validation activities while adhering to the client's operational timelines and regulatory expectations.