At Prism Calibration, we specialize in providing comprehensive validation services to ensure the highest levels of regulatory compliance, operational efficiency, and quality assurance for your equipment and processes. Whether you operate in pharmaceuticals, biotechnology, food processing, or other industries, our ISO 17025-certified validation services guarantee that your systems meet international standards like FDA compliance and ISO regulations. Explore our detailed guide to understand the importance of validation, its benefits, and why we are the trusted choice for validation services.
Validation is the process of documenting and verifying that a system, process, or piece of equipment consistently produces results meeting predetermined specifications. It is a critical step in ensuring regulatory compliance, product quality, and operational efficiency. At Prism Calibration, we offer a wide range of validation services, including temperature mapping, sterilizer validation, SCADA validation, laboratory instrument validation, and HEPA filter validation.
Temperature Mapping Validation
We ensure accurate control of temperature in sensitive environments like labs, clean rooms, and storage spaces. Our temperature mapping services help maintain regulatory compliance by monitoring temperature stability.
Sterilizer Validation
Our sterilizer validation services verify the efficiency of autoclaves and other sterilization equipment, ensuring compliance with industry standards and ensuring safe sterilization processes.
DHS Validation (Dry Heat Sterilizer)
Dry heat sterilizers must perform reliably to ensure material safety. Our DHS validation services assess the performance of these sterilizers and ensure compliance with health and safety regulations.
HEPA Filter Validation
We test and validate the efficiency of HEPA filters to ensure cleanroom and laboratory air quality standards are met. HEPA filter validation is crucial for maintaining optimal air filtration in controlled environments.
SCADA System Validation
Our SCADA validation services ensure that your automated systems run smoothly and accurately monitor your facility’s operations. This is essential for industries relying on real-time monitoring and control.
Laboratory Equipment Validation
Our laboratory equipment validation services cover a range of instruments, ensuring they perform accurately and meet compliance requirements, crucial for maintaining the integrity of laboratory data.
Validation services are essential across various industries to ensure compliance with regulatory standards and maintain operational efficiency. Here’s how validation services benefit specific sectors:
– Sterilizer Validation: Ensures that sterilization processes meet FDA compliance and GMP standards.
– Temperature Mapping: Validates temperature-controlled storage areas like cold rooms and warehouses.
– Benefits: Ensures product safety, meets regulatory requirements, and reduces the risk of recalls.
– Laboratory Instrument Validation: Ensures the accuracy and reliability of instruments used in research and development.
– HEPA Filter Validation: Validates the efficiency of HEPA filters in cleanrooms.
– Benefits: Ensures data integrity, meets ISO 17025 certification, and maintains regulatory compliance.
– SCADA Validation: Ensures the accuracy and reliability of Supervisory Control and Data Acquisition (SCADA) systems.
– Temperature Mapping: Validates temperature-controlled processes like pasteurization and refrigeration.
– Benefits: Ensures product quality, meets HACCP standards, and reduces waste.
– DHS Validation: Ensures the accuracy and reliability of Diagnostic and Healthcare Systems (DHS).
– Software Validation: Validates software used in medical devices and healthcare systems.
– Benefits: Ensures patient safety, meets FDA compliance, and maintains regulatory compliance.
At Prism Calibration, we follow a meticulous step-by-step validation process to ensure your systems meet the highest standards. Here’s how we do it:
– Planning: Define the scope, objectives, and acceptance criteria.
– Installation: Place temperature sensors in critical locations.
– Data Collection: Monitor and record temperature data over a specified period.
– Analysis: Analyze the data to identify any deviations.
– Reporting: Provide detailed validation reports and recommendations.
– Installation Qualification (IQ): Verify that the sterilizer is installed correctly.
– Operational Qualification (OQ): Verify that the sterilizer operates within specified parameters.
– Performance Qualification (PQ): Verify that the sterilizer consistently produces the desired results.
– Reporting: Provide detailed validation reports and recommendations.
– Requirement Analysis: Define the system requirements and acceptance criteria.
– Design Review: Review the system design to ensure it meets the requirements.
– Testing: Perform functional and performance testing.
– Reporting: Provide detailed validation reports and recommendations.
– Laboratory Instrument Validation
– Installation Qualification (IQ): Verify that the instrument is installed correctly.
– Operational Qualification (OQ): Verify that the instrument operates within specified parameters.
– Performance Qualification (PQ): Verify that the instrument consistently produces accurate results.
– Reporting: Provide detailed validation reports and recommendations.
– Installation Qualification (IQ): Verify that the HEPA filter is installed correctly.
– Operational Qualification (OQ): Verify that the HEPA filter operates within specified parameters.
– Performance Qualification (PQ): Verify that the HEPA filter consistently produces the desired results.
– Reporting: Provide detailed validation reports and recommendations.
We adhere to the highest industry standards and certifications, including:
– Ensures the competence of testing and calibration laboratories.
– Guarantees measurement accuracy and traceability.
– Meets the requirements of the U.S. Food and Drug Administration.
– Ensures product safety and regulatory compliance.
– Ensures that manufacturing processes meet Good Manufacturing Practices.
– Critical for the pharmaceutical and biotechnology industries.
– Ensures that food processing systems meet Hazard Analysis and Critical Control Points standards.
– Critical for the food processing industry.
At Prism Calibration, we conduct a thorough protocol and equipment assessment to ensure that your systems meet regulatory standards and operational requirements. This includes:
– Identify potential failure modes and implement preventive measures.
– Ensure that your systems operate within safe parameters.
– Develop and implement validation protocols tailored to your specific needs.
– Ensure that your systems meet regulatory requirements.
– Evaluate the performance and condition of your equipment.
– Ensure that your equipment operates within specified parameters.
Calibration ensures that an instrument’s measurements are accurate by comparing them to a known standard, while validation confirms that equipment or systems perform according to their intended purpose, consistently meeting industry standards. Both are crucial for compliance in regulated industries.
Temperature mapping validation is vital in controlled environments such as cold storage facilities, clean rooms, and warehouses. It ensures that these areas maintain the required temperature ranges uniformly, helping to protect sensitive products and comply with regulatory standards.
Prism Calibration is NABL Accredited and known for its highly skilled professionals, state-of-the-art laboratory, and comprehensive range of services. We provide tailored solutions including SCADA validation, laboratory instrument validation, HEPA filter validation, and more, ensuring that every aspect of your equipment meets the highest standards.
It is recommended to perform HEPA filter validation annually or after any major system changes. SCADA system validation should be done regularly to ensure that automated systems for industrial processes remain reliable and efficient. Revalidation is critical after significant system modifications or maintenance.
Proper documentation is essential in validation to ensure compliance with regulatory bodies like ISO, GMP, and NABL. It provides evidence that equipment and processes have been validated according to standards, offering a verifiable audit trail for inspections and certifications.
Yes, Prism Calibration provides services internationally. Though based in India, we cater to global clients across various industries, offering high-quality validation services to meet international standards.
You can contact us directly through our website, where you’ll find an Inquiry Now or Contact Us button on our service pages. Our expert team is available to assist you with specific validation and calibration requirements tailored to your industry and facility needs.
