PLM Solutions for Life Science

Industry:	Healthcare
Client since:	2016

Established QA system

Improved knowledge transfer

Custom Agile approach

Services used

Application Development Experience Design Software Testing & QA

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Outdated document-intensive processes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.

Challenges

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 team helped NeoPLM make a shift to proper Team Foundation Server tracking (now Azure DevOps), having 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:

Improved communication through establishing different channels, introducing elements of Agile Project Management, on-site and local meetings, planning sessions, retrospective and Daily Status Update meetings with customers.
Implemented proper toolset configuration for Testing and reporting test results.
Introduced new metrics for reporting processes.
Helped with on-site Audits, demonstrated Test evidences and references of Test Process to existing procedures on the project.
Added new test types (Smoke, Functional, Regression), as well as the release cycles and all related iterations.
Improved ad-hoc testing processing for both Web and Desktop application parts, including new test and estimation techniques.
Collected test cases into test suites, created a test case database, introduced QA cycles and improved requirements gathering, planning and bug triage process.
Created detailed knowledge transfer plan, instructions and functionality presentations for onboarding and teaching new QA team members.
Customized bug tracking and updated related documentation.
Investigated automation testing toolset suitable for the project needs.

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. Symphony Solutions team is also involved in customer audits.

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

Symphony Solutions has introduced Neo to Agile, customizing and adjusting it to the client’s needs. Combining Agile and Waterfall in a flexible mix of methodologies, helped create a custom system that suited the client’s needs and preferences due to industry specifics.