PLM Solutions for Life Science

Industry:	Healthcare

Services

Application Development
Experience Design
Healthcare

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Outdated document-intensive processes.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.

As a result, pharmaceutical manufacturers face serious challenges accessing, communicating, and acting upon the information needed to support timely product delivery and quality assurance.

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.

This helps companies improve quality and efficiency, reduce compliance risk and product costs substantially, and empower knowledge-driven innovation across all core business functions.

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 provides QA and software testing services in a way of establishing a 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.

Results

Through the new QA system, Neo improved the flow and transfer of knowledge across all stakeholders and processes.

The QA system radically improved overall product quality, and the verification of new features and updates in particular. This helped Neo attract new customers—including life sciences industry leaders Johnson & Johnson, Pfizer, and Biogen—which then became clients of Symphony Solutions.

As a result of this success, the partnership with Symphony Solutions continues to grow, as Neo:

Requested additional QA staff and added a part- time tech writer to the Symphony Solutions team.
Plans to expand the engagement to include automation testing and a 24-hour support team.
Plans to add a software developer to the Symphony Solutions team.