Life Sciences Solutions
Actemium Avanceon understands that delivering the safest and most effective products is crucial to survival in the Life Sciences Industry. We partner with you to ensure the full compliance and superior quality control that governs pharmaceutical manufacturing.
We’ll cover quality assurance and validation, drug stability, and contamination control—all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines.
Improve Your Life Sciences Manufacturing
Unlike typical manufacturers, Life Sciences companies must be particularly cautious in the trust they place in their integrators. With Actemium Avanceon, you can be confident in our experience and ability to navigate the complexities of federal compliance measures, such as 21 CFR Part 11. Our engineers have a proven track record of successfully managing the validation of these requirements and testing protocols. Additionally, Actemium Avanceon has made significant efforts to address serialization concerns. Our deep understanding and experience with this process enable us to improve efficiency and reduce packaging line costs.
Life Sciences Industry Solutions
Actemium Avanceon delivers a wide variety of solutions to the life sciences market including:
- PLC and HMI/SCADA software development, including batch and continuous processes, packaging lines, and machine control
- MES integration, including order entry and tracking, reporting, OEE calculation, and interface to ERP systems
- Automation consulting services, including platform upgrades, standards definition, production rate analysis and process optimization, and many other topics
- Electrical Design and fabrication of control panels
- Specification development, including collaboration to define User Requirements, as well as Functional and Design Specifications. Includes all areas of GAMP documentation, such as Risk Assessments and Design Qualification
- Test Protocol development and execution, including Installation, Operational, and Process Verification / Qualification that comply with standards/regulations in an antiseptic environment
- Troubleshooting – Keeping those pills coming on time
Validation
Actemium Avanceon has a long-standing history of providing validation services for both the projects we develop and those that we do not. Our expertise in Computer System Validation goes beyond simply “executing the protocol”, we add value at every stage.
We have significant experience with projects affected by federal guidelines. We plan, develop, and execute validation in collaboration with many industry-leading, regulated clients. By leveraging our internal Standards & Tools throughout the project lifecycle, we ensure consistent, high-quality documentation and deliverables.
Using a GAMP5 risk-based lifecycle approach, we:
- Strive for more efficient validation processes
- Enhance system functionality
- Achieve greater user satisfaction
At Actemium Avanceon, we have extensive expertise in FDA compliance and are dedicated to optimizing your systems, plants, and equipment to meet regulatory standards. Whether your project requires consulting or validation services for a single piece of equipment, a comprehensive process solution, or validation for an entire facility, we have the knowledge and experience to provide the support needed and ensure full compliance.
