Pharmaceuticals
Solution Implementation
TechExcel comprehensive and easily configurable solutions offer:
- Role-based accountype and role-based security
- Integrated database (CMBD) to ensure data integrity
- Timestamps for each change and accurate change histories maintained for all files
- Automated workflows for each phase of product development and delivery
- Task (issue) management and process validation
- Quality metrics and reporting for management
Overview and Challenges
Costly, high-risk discovery periods. Increasingly stringent clinical trials. Shrinking patent expiration limits. Software has become a critical part of the fast changing and highly-regulated pharmaceutical industry. Research and development project managers must have easily adaptable and agile tools to aid in strategic development, project planning and tactical execution. These tools must enable managers the means to keep projects moving, set up interactions with internal and external stakeholders, and track and record the complex process for FDA-required regulatory guidelines. Moreover, clinical trial managers need an integrated tool to combine and manage patient data with treatment, condition, disease states and population health-management assessments.
TechExcel solutions for the pharmaceutical industry helps enterprises meet business challenges with a powerful combination of comprehensive applications including key functionality built specifically for the life sciences industry.
Reduce Risk through Process Validation and Compliance
From planning through to trials and compliance regulations, TechExcel is your trusted partner to help minimize risks, ensure compliance, and avoid costly recalls. Pre-built tools enable electronic signatures and automate regulatory recordkeeping, so you can maintain secure and auditable trails of information at every phase of development, validation and delivery. Flexible and global workflows enable all stakeholders to confidently monitor, validate and ensure security.
TechExcel DevSuite solutions provide a powerful framework for project planning and execution, with knowledge at its core, keeping intellectual assets including project related data, reference, requirements and documents at the team's fingertips. Combining TechExcel DevSuite with TechExcel Service Suite solutions connect projects with customers and patients and encompass the entire product lifecycle, from research and development, to manufacturing, to various stages of clinical trials and through to distribution.
