In today's highly regulated industries, Validation Services play a crucial role in ensuring compliance, efficiency, and reliability. At Alpharma, we specialize in providing comprehensive validation solutions tailored to meet the unique needs of your organization. From facility commissioning to laboratory equipment qualification, our services cover a wide range of areas to ensure that your operations meet regulatory requirements and industry standards.
Facility Commissioning & Decommissioning
Proper commissioning and decommissioning of facilities are essential steps in ensuring regulatory compliance and operational readiness. Our team of experts works closely with you to plan and execute commissioning and decommissioning processes efficiently, minimizing downtime and ensuring compliance with applicable regulations.
HVAC Validation
Heating, Ventilation, and Air Conditioning (HVAC) systems play a critical role in maintaining environmental conditions within regulated facilities. Our HVAC validation services ensure that your systems operate effectively and meet regulatory requirements, providing a controlled environment for your operations.
21 CFR Part 11 Compliance
Compliance with 21 CFR Part 11 is essential for organizations operating in regulated environments, particularly in the pharmaceutical and life sciences industries. Our validation services ensure that your computer systems meet the requirements of 21 CFR Part 11, including electronic recordkeeping and electronic signatures.
Computer System Validation (CSV)
Computer System Validation (CSV) is vital for ensuring the integrity and reliability of computerized systems used in regulated processes. Our validation experts follow industry best practices to validate your computer systems, ensuring that they perform as intended and meet regulatory requirements.
Process Control & System Validations
Effective process control and system validations are essential for maintaining product quality and ensuring regulatory compliance. Our validation services cover a wide range of processes and systems, including manufacturing processes, analytical methods, and laboratory systems, to ensure that your operations meet regulatory requirements.
Laboratory Equipment Qualification
Accurate and reliable laboratory equipment is critical for generating reliable data and ensuring product quality. Our qualification services ensure that your laboratory equipment meets performance specifications and regulatory requirements, providing confidence in the accuracy and reliability of your test results.
Laboratory Information Management System (LIMS) Qualification
Laboratory Information Management Systems (LIMS) play a crucial role in managing laboratory data and workflows. Our qualification services ensure that your LIMS meets regulatory requirements and performs reliably, enabling efficient data management and compliance with industry standards.
Calibration and Metrology Programs
Effective calibration and metrology programs are essential for maintaining the accuracy and reliability of measurement instruments. Our calibration services ensure that your instruments are calibrated to traceable standards and meet regulatory requirements, providing confidence in the accuracy of your measurements.
At Alpharma, we are committed to providing high-quality validation services that enhance compliance, efficiency, and reliability across your organization. Contact us today to learn more about how our validation services can support your regulatory compliance efforts and drive operational excellence.