Standards

Systems and facilities • Standard 03

Quality Assurance

Laboratory practices, validated environments, monitored equipment, documentation, and training support reliable research materials.

Policy and supporting detail

Quality Assurance

Read the complete source policy below. Questions about how a standard applies to a project can be directed to the LeoCorps team.

Leo corps oversees the establishment of state-of-the-art laboratories that follow the Good Manufacturing and Good Research Practices general guidelines and meet the industry’s highest level of regulatory compliance. When it comes to non-compounded biospecimens and cellular products for research, quality control is critical for all applications of human-derived materials and reagents at Leo Corps.

We adhere to strict guidelines for donor screening, records management, validation, training, certification, and project management to ensure that from start to finish we have the most reliable and quality-assured products to support our clients research and drug discovery projects.  We pride ourselves on providing R&D products that have higher viability and vitality than similar products on the market. Customers can be confident that they are using standardized materials that are compliant with Good Manufacturing and Good Research Practices guidelines and policies.

Our R&D products are processed at a state-of-the-art certified facility equipped with validated and tested ISO 5 and ISO 7 clean rooms to ensure the industry’s highest level of regulatory compliance. We are constantly vigilant about maintaining industry best practices and monitoring the facilities and equipment. In this way, we can be sure that our laboratories are best equipped to produce the highest quality starting material for research and development applications.

Need clarification?

Connect the standard to your requirements.

Contact LeoCorps to discuss donor criteria, material specifications, documentation needs, processing requirements, or order terms.