Automation and Validation Services for Pharmaceutical and Biotechnology
Cross Company Process Control Integration is the only Siemens Certified Partner in the United States and can support all your pharmaceutical and biotechnology automation needs. We offer both automation and validation services to ensure a successful and cost-effective project while providing the highest quality service with the strictest confidentiality.
We are also a Control System Integrators Association (CSIA) certified firm and our Quality Assurance program follows the GAMP5 model to assure compliance. This strict certification and experience reflect our commitment to providing quality and excellence to the automation industry. Our engineering department has an established reputation for providing innovative solutions for complex applications while maintaining compliance with regulations throughout our history. All of our solutions are designed to comply with 21 CFR Part 11 requirements. We are also capable of implementing and realizing the benefits of process analytical technology (PAT) to increase operational efficiency.
The flexibility of our services allows us to assist in any or all aspects of the computer validation process. Our proven experience ensures that the design, implementation, operation and qualification efforts progress smoothly and accurately. Our project management team maintains oversight on all aspects from start to finish ensuring that project milestones are met within the budget and schedule. We have the automation experts on staff that will maintain ownership and provide as much assistance as necessary to meet your goals throughout the project lifecycle.
- Aseptic Filling
- Basis of Design (BOD) Specifications
- Batch management Systems
- Batch Reporting
- Bioprocess Design
- Building Automation Systems
- Clean In Place (CIP) Applications
- Clean Room Solutions
- Computer System Validation
- Detail Design Specifications
- Factory Acceptance Test Protocol
- Functional Design Specifications
- Impact Assessment (IA)
- IQ/OQ/PQ Protocols
- MES Tie-in for Batch Campaigns
- Process Architecture
- Project Quality Plan (PQP)
- Site Acceptance Testing
- Traceability Matrix
- User Requirement Specifications
- Water For Injection Systems
Interested in learning more about how Cross company can help your operation? Contact us today to discuss your application with a Cross team member.