About Us

At QSOL – Quality Solutions, we help businesses achieve excellence in quality and compliance. Our team of seasoned experts provides tailored consulting services across industries like pharmaceuticals, biotechnology, and medical devices. We specialize in quality management system development, process validation, and cleanroom services, delivering customized solutions that ensure compliance and drive efficiency. Partnering with QSOL gives you access to extensive knowledge and experience, empowering your organization to exceed regulatory standards. We are dedicated to building strong client relationships and delivering exceptional support for your long-term success.

Our Mission

To empower businesses to achieve and maintain the highest standards of quality and compliance through expert consulting, tailored solutions, and unwavering support.

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Our Goal

To be the trusted partner for organizations in regulated industries, helping them navigate complex compliance landscapes, optimize operations, and ensure the health and safety of their products and patients.

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How It Works

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Consultation

Our process begins with a thorough consultation where we take the time to understand your specific needs and challenges. Our experts will assess your current compliance status, identify potential risks, and provide insights into regulatory requirements relevant to your industry. This initial consultation sets the foundation for a tailored approach that addresses your unique circumstances

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Customized Solutions

Based on the insights gained during the consultation, our team of industry experts will develop customized solutions designed to meet your specific needs. Whether it’s quality management system development, process validation, or cleanroom services, we craft a strategic plan that aligns with your business goals and regulatory requirements. Our solutions are designed to ensure compliance, enhance operational efficiency, and support continuous improvement.

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Implementation and Support

Once the customized solutions are finalized, our team will work closely with you to implement them effectively. We provide hands-on support throughout the implementation process, ensuring that all procedures are seamlessly integrated into your operations. Our commitment doesn’t end with implementation; we offer ongoing support to help you maintain compliance, address emerging challenges, and continually optimize your systems. With QSOL, you gain a reliable partner dedicated to your long-term success and operational excellence.

Services

Commissioning, Qualification, and Validations (CQV)

At QSOL, we provide end-to- end CQV services to ensure your manufacturing processes are fully compliant and operationally efficient. Our team collaborates with you to develop and implement reliable validation programs, conduct gap assessments, and perform comprehensive qualifications for facilities, equipment, and utilities. From cleaning and sterilization validation to process validation, our services minimize risks and ensure your product meets quality standards.

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Quality Investigations and CAPA Support (QMS)

Our Quality Investigations and CAPA support services help you identify the root cause of discrepancies and implement effective corrective and preventive actions. We integrate with your team to conduct thorough investigations and develop solutions that facilitate continuous improvement and regulatory compliance.

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Inspection Readiness and GxP Audits

Our audit and inspection services help you identify compliance gaps and implement corrective actions to meet regulatory requirements. We provide thorough assessments and support to ensure your operations adhere to industry best practices and regulatory standards. Our experts work with you to address issues and enhance your quality systems effectively.

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Certification of Cleanrooms

QSOL offers comprehensive cleanroom certification services to maintain the highest standards of cleanliness and compliance. Our certification process includes particle count testing, microbial testing, airflow velocity and direction testing, temperature and humidity monitoring, pressure differential testing, ESD testing, room air balance, compressed air/gas sampling, lighting testing, and vibration testing. We ensure your cleanrooms meet industry standards such as ISO 14644, USP 797/800, EU GMP Annex 1, and FDA 21 CFR Part 11.

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Cleanroom Consumables Sales

We provide a wide range of high-quality cleanroom consumables to support your operations. From gloves and gowns to cleaning agents and equipment, our products are designed to maintain the integrity of your cleanroom environments. Our team ensures you have the necessary supplies to keep your controlled environments compliant and efficient.

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Staff Support & Outsourcing

At QSOL, our network of CQV professionals enhances your internal capabilities, ensuring project timelines are achieved by leveraging experienced experts. Our team seamlessly integrates with your engineering, quality, and validation departments, while our management team offers a direct communication channel for any operational support regarding the deployed resources.

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