Pharmaceuticals& biotech 4.0
Achieve Audit Readiness and Operational Excellence with SkilDpot
- Leverage our deep domain expertise across sectors to drive your digital transformation
Are You Facing These Challenges?
- Frequent regulatory compliance issues with the FDA
- Large inventory holds due to deviation investigations
- Loss of batches because of missing documentation
- Production stoppages due to incomplete training records
At SkilDpot, we are committed to helping you remain audit-ready while operating at a high level of excellence. By thoroughly analyzing your existing processes, we identify gaps and transform them through simplification and solution engineering of industrial plant IT applications (such as MES, L2 systems, QMS, LIMS, eLogbook, etc.), along with qualification and system validation. Our paperless solutions enhance productivity and streamline your operations, ensuring compliance and efficiency.
Our PHARMACEUTICAL 4.0 Services
Automation Engineering
We offer comprehensive end-to-end industrial automation engineering services, covering the entire project lifecycle from project management, concept design, development, and commissioning, to testing, validation, and operational support post-system launch.
When you need to integrate diverse, multivendor systems, equipment, and devices, reach out to SkilDpot. We provide comprehensive shop floor data collection, detailed reporting, and advanced supervisory control. Our visualization tools offer clear, real-time insights into operations, ensuring reliable production data is seamlessly delivered to higher-level analytic applications.
Manufacturing Execution System (MES)
The SkilDpot team boasts extensive experience and expertise in life science industrial MES solutions, including Koerber PAS-X, Rockwell FTPS, and Emerson Syncade. We manage projects from start to finish, ensuring seamless integration with various third-party systems such as scales, ERP, and L2 systems.
We offer a full suite of solution engineering services, including:
- project management
- understanding and addressing specific customer requirements
- product evaluation and selection
- concept design
- budgeting
- implementation
- training
- operational support
Qualification & Computer System Validation
Our Comprehensive Services Include:
- Initial Implementation: Starting from scratch or handling Requalification/Revalidation for changes, patches, extensions, and periodic reviews.
- Consulting Services: From initial preparation to review, execution, and approval of Qualification and Validation documents.
Key Offerings:
- GAP Analysis: Identify and address gaps in your current systems.
- User Requirement Specification: Define and document your system requirements.
- Validation Plan & Report: Develop and document validation strategies and outcomes.
- Design Specification: Detailed design documentation for your systems.
- Configuration Document: Comprehensive configuration details.
- IQ, OQ & PQ Script & Report: Installation, Operational, and Performance Qualification scripts and reports.
- Cut Over Strategy: Effective strategies for system transitions.
- Requirement Traceability Matrix: Ensure all requirements are met and traceable.
- 21 CFR/EU Annex Compliance Checklist: Compliance with regulatory standards.
- Data Integrity Checklist: Maintain data integrity throughout your systems.
- Support for Audit Readiness: Prepare for audits with our expert support.
Paperless Qualification / Validation – ValGenesis
Embrace the industry standard for digitalizing qualification and system validation in the life sciences sector with our paperless, workflow-driven solution. Our approach ensures standardization and provides digital guidance at every step of the qualification and validation process.
At SkilDpot, we leverage our extensive experience with solutions like ValGenesis to offer seamless, paperless, and system-guided execution. We provide comprehensive services, including:
- End-to-End Implementation
- Project Management
- Budgeting & Ordering
- Process Mapping
- Master Data & Template Modelling
- System Validation
- Training
- Hypercare Support
- Application support and maintenance
Digital Transformation Solution
Driven by smart technology and intelligent devices, our approach reshapes businesses by driving smart manufacturing, enhancing operational efficiency, maximizing productivity, and boosting Overall Equipment Effectiveness (OEE). Our solutions also help reduce manufacturing costs and improve supply chain performance.
Our Expertise Includes:
- Asset Management
- Production Monitoring
- Quality Management
- Inventory Management
- Recipe Management
We leverage the latest technology and independent platforms to map requirements for both horizontal and vertical integration of your manufacturing processes. Our KPI-based modules enable a block-by-block digital transformation, ensuring your operations are optimized and future-ready.
Why Choose Us?
- Comprehensive Support: We assist manufacturers in identifying their current position in the digital transformation journey and planning to achieve their goals.
- Rich Industrial Knowledge: Our team brings extensive experience and expertise in end-to-end implementation.
- Diverse Services: We provide a wide range of services, including MES, QMS, VMS, RPA, IIoT, Analytics, L2-L3-L4 Interfaces, Cybersecurity, eLog, IT-OT Integration, Data Lake, and more.
Partner with us to achieve seamless, efficient operations
Our expertise will help you navigate regulatory challenges, improve productivity, and maintain compliance with ease.