by Instem Team | May 5, 2026 | Quality System Management, Resources
Life sciences organizations operate under some of the most complex and rapidly evolving regulatory frameworks in the world. As companies scale across geographies, fragmented document management systems, disconnected training records, and manual workflows introduce...
by Instem Team | Apr 28, 2026 | Resources
ISO/IEC 17025 is the internationally recognized standard for testing and calibration laboratories, setting expectations for technical competence, impartiality, and the reliability of laboratory results. Meeting these requirements demands consistent control over...
by Instem Team | Apr 16, 2026 | Resources, SEND
SEND continues to evolve as regulatory expectations grow and nonclinical research becomes more complex. With SEND 4.0, organizations will face major updates, including new immunology, dermal, ocular, and pathology‑focused domains, as well as structural changes such as...
by Instem Team | Apr 15, 2026 | Quality System Management, Regulatory Submission, SEND
IND Package Preparation Successful IND submissions rely on comprehensive and regulatory-compliant preclinical data, CMC information, and clinical protocol documentation. IND readiness, including SEND documents, is where earlier data quality decisions are rewarded or...
by Instem Team | Apr 13, 2026 | NOTOCORD-hem, Study Management
NOTOCORD-hem is a comprehensive, GLP-compliant software platform for assessing physiological functions across cardiovascular, respiratory, and nervous system applications in nonclinical and life science academic research. With more than 160 advanced modules, the...
