Your Single Digital Platform for Generics & Specialty Pharma R&D, Quality, Compliance, Laboratory and Manufacturing Operations
Today’s Generics and Specialty Pharmaceutical companies are highly competitive in a crowded marketplace with the same strict regulatory scrutiny and enforcement as larger Pharmaceutical organizations. However, Generics and Specialty Pharma companies are forced to meet these standards with fewer resources and tighter margins than “Big Pharma.”
In order to be successful and actually thrive under these conditions management needs to have sharp focus on:
- Reducing ramp up time, reduced errors & deviations and improve quality.
- Improving efficiencies and cost savings
- Optimizing operations – higher throughput with existing resources
- Reducing Audits, FDA inspections and 483 Risks
Xybion’s Generics and Specialty Pharma XD (GSP-XD) digital cloud-based platform is uniquely developed to satisfy the demands of Generics and Specialty Pharmaceutical organizations.
Key Distinctive features:
- Pre-configured workflows and audit-ready reporting – reduces audit risk
- Compliance PredictorTM module allow for understanding 483 patterns and manage internal SOPs and processes to be always ready to successfully meet the FDA inspection requirements.
- Data Integrity ensures that data is complete, consistent, and accurate.
You can continue to manage your critical quality assurance, compliance and R&D operations with paper-based or legacy technologies, but no combinations of these solutions will allow your organization to scale and reach critical mass in an efficient and cost-effective manner. Xybion’s GSP-XD platform can help you achieve step changes in your company’s performance and improve your Return-On-Investments (ROI)
Out-of-the-Box Functionality
With its pre-configured workflows and ready-to-deploy functionality, GSP-XD provides you with the digital platform and tools to effectively manage your daily operations:
- Formulation Management
- Stability Study Management
- Document Management for storing all of your document from Patent Challenge to product, QC methods, Production methods, ANDA Compliance and Quality Management on a single platform
- Validation Management
- Predictive Compliance
- Corrective and Preventative Actions (CAPA)
- Audit Management
- Complaint Handling
- Employee Training and Competency Management
This cloud-based solution allows customers to deploy the solution rapidly and adapt to existing requirements without the complexities of configuration and ongoing maintenance. However, GSP-XD is built on Xybion’s highly configurable, low code technology stack which facilitates “configurations” vs. “customizations.” In layman’s terms, this simply means that we can deliver client specific workflows and processes in DAYS as opposed to MONTHS with older legacy based applications. This also means that our clients are provided a high level of control allowing them to change and configure their instance WITHOUT affecting core code, hence no need to re-validate.
Meeting Your Needs Today AND in the Future
In addition to being out-of-the-box ready, GSP-XD is a modular platform, meaning that additional functionality or modules can be deployed rapidly without disrupting existing business operations and ensuring business continuity. This modular approach allows you commit to and deploy ONLY the functionality that you need TODAY and remain positioned to scale and ramp up rapidly new functionality as needed. GSP-XD provides One Platform and One Solution to meet your digital workplace demands wherever you are at in your manufacturing journey.