Navigating the complex landscape of regulatory compliance can be daunting. klima offers comprehensive validation and compliance services to ensure that your cleanroom facilities meet stringent international standards such as USFDA, MHRA, WHO, and more. Our expertise in regulatory requirements helps you achieve and maintain compliance, safeguarding product quality and patient safety.
Avoid costly delays and rework with our systematic validation process.
Reduce regulatory risk and improve inspection outcomes with thorough compliance documentation.
Achieve quicker approvals by demonstrating adherence to the highest quality standards.
We develop comprehensive validation master plans tailored to your specific processes and regulatory requirements, setting the framework for a compliant and efficient validation process.
Our team conducts detailed Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to ensure your systems operate within specified parameters.
Identify potential compliance gaps early with thorough risk assessments, ensuring proactive measures are in place to address any issues before regulatory inspections.
We provide meticulous documentation for every validation step, including standard operating procedures (SOPs), test protocols, and detailed reports, facilitating smooth regulatory audits.
Post-validation, we offer training programs to ensure your staff is well-equipped to maintain compliance and handle any regulatory updates.
Partner with klima to bring your cleanroom vision to life, with a focus on precision, compliance, and operational excellence.
