Support team rating
TCell rated the Inflectra support team 10 out of 10.
Pharmaceutical Validation Case Study
TCell Clinical Services: Elevating Pharmaceutical Validation with Inflectra
TCell Clinical Services adopted SpiraTeam to streamline pharmaceutical validation documentation, strengthen compliance, and centralize QA processes across U.S. and European operations.
TCell Clinical ServicesCustomer
PharmaceuticalIndustry
30Projects
20Team members
Challenge
Jira did not meet pharmaceutical validation needs
The JNarratives project focused on streamlining the creation and management of pharmaceutical validation documents under stringent industry requirements.
The case study lists 21 CFR Part 11 compliance as a regulatory consideration and states that Jira was insufficient for TCell’s pharmaceutical validation requirements. TCell therefore moved to SpiraTeam.
Solution
A centralized validation and QA system
SpiraTeam helped TCell streamline validation processes and ensure compliance with pharmaceutical industry standards. The resulting environment centralized QA processes and improved documentation structure.
The case study says pharmaceutical validation documents were created in record time while maintaining a strong focus on quality.
SpiraTeam21 CFR Part 11Validation documentationTraceabilityAuditabilityQA management
Results and benefits
Measurable improvements and a stronger operating model.
Platform efficacy
The case study reports a platform-efficacy rating of 4 out of 5.
Projects
The case study lists 30 projects supported by a 20-member team.
Pharmaceutical validation documents were created in record time with Inflectra, demonstrating our unwavering focus on quality.Ram S., Managing Director
Next steps
Future utilization plans
TCell plans to extend its use of Inflectra products to capture risk assessment information and integrate it into Agile methodologies.
Streamline regulated validation, traceability, and QA with SpiraTeam.
For more information, contact Inflectra.