PLM Solutions for Life Science
Services
- Design
- QA and Testing
Background
Pharmaceutical and biotech companies are competing in a globally distributed business environment for their share of a $1.2 trillion market. The pathway from R&D to manufacturing to customers is highly regulated, yet knowledge management mostly remains fragmented and unstructured.
Factors contributing to the complexity include:
- Information silos within companies.
- Outdated document-intensive processes.
- Increased outsourcing of production.
- Plants manufacturing multiple products.
- Production transfers between facilities.
Client
Neo PLM is a Product Lifecycle Management (PLM) provider to life sciences companies, including pharmaceutical and biotech organizations, and other process manufacturers. Neo developed the first integrated process PLM solution in the industry to unite stakeholders spanning the entire product lifecycle, from late-stage research through manufacturing.
Through a digital process design-based approach to managing knowledge and manufacturing, the Neo suite bridges communication divides, fills information voids, and standardizes processes surrounding:
- Recipe management.
- Technology transfer and plant data configuration.
- Manufacturing planning/optimization, including design of chemical processes and what-if planning.
- Management of the process design for the full lifecycle.
- Historical data analysis.
Issue
Neo engaged Symphony Solutions in 2016 to implement needed QA processes including:
- Improved requirements.
- Test case database and QA cycles.
- Proper toolset configuration.
- Flexible mixed methodology with the best aspects of Agile and Waterfall.
Solutions
Symphony Solutions established a thorough QA system to suit the complexities of the industry, and has consistently improved the quality of the solution over time. Additionally, Symphony Solutions:
- Established different communication channels and main QA processes, including on–site meetings.
- Improved reporting processes, added new metrics, and helped with the audit process on–site.
- Added new test types such as Smoke, Functional, Regression, and release cycles.
- Added test suites and test cases DB separated by functionality components.
- Customized a bug tracking system to meet QA requirements.
- Generated presentation materials and knowledge transfer plans to assist the on-boarding of new QA team members.
The main responsibilities of the testing team were:
- Requirements analysis.
- Documentation creation.
- TC execution.
- Defects tracking.
- Reporting results.
