Modernizing Software Lifecycle Compliance: Implementing CSA for a Top 30 Pharma Company
The Ask
As part of its growth strategy, a top 30 pharmaceutical company acquired multiple smaller organizations, each with varying levels of software lifecycle (SLC) maturity. The client needed to integrate these acquisitions into its global SLC while modernizing validation policies using Computer Software Assurance (CSA) principles.
Challenges included:
Acquisition 1: Existing SLC required alignment with the client’s global framework and an updated risk assessment approach.
Acquisition 2: No SLC or computer system validation (CSV) framework in place.
Acquisition 3: No formal SLC, but CSA principles were already implemented.
Beyond acquisition integration, the client sought to optimize its global SLC by embedding CSA principles for a risk-based, efficient validation process.
Solution
Statera Consulting executed a structured approach to assess, align, and optimize software lifecycle management across the organization.
Key initiatives included:
Gap Assessment & Strategy Development: Conducted an in-depth evaluation of each acquisition’s SLC maturity and mapped a tailored integration plan.
SLC Harmonization & Risk-Based Validation: Standardized validation practices across all acquisitions while ensuring compliance efficiency.
CSA-Driven Validation Implementation: Leveraged CSA principles to streamline validation, reducing unnecessary documentation and redundant testing.
Global SLC Redesign: Revamped the enterprise-wide SLC framework to support future acquisitions and compliance needs.
Results
Within the project timeline, Statera Consulting delivered:
Seamless Acquisition Integration: Successfully aligned all newly acquired companies with the client’s global SLC.
Optimized Validation Efforts: Reduced validation documentation and testing overhead by 40%.
Enhanced Risk-Based Approach: Strengthened risk assessment methodologies for software validation.
Future-Ready SLC Framework: Implemented a scalable and efficient SLC model that supports ongoing growth and regulatory requirements.
By helping our client modernize their global SLC keeping CSA principles in mind, Statera Consulting helped our client enhance their compliance efficiency, reduce the burden of validation, and provided a scalable framework for integrating future acquisitions.
