by Instem Team | Jul 1, 2026 | Resources
Assessing chemical impurity and extractables and leachables (E&L) safety requires integrating mutagenicity screening with systemic toxicity information to support scientifically sound, health-based limits. As regulatory expectations evolve and chemical spaces grow...
by Instem Team | Jun 30, 2026 | Compliance Builder, Quality System Management, Regulatory Submission
In this recap, we’ll cover the challenges associated with 21 CFR Part 11 compliance, the hidden costs of non-compliance, and how Compliance Builder and eQCM help laboratories identify, manage, and close gaps across the full data lifecycle. On Wednesday, June 3, 2026,...
by Instem Team | Jun 9, 2026 | Resources
Recent FDA communications have made clear that poor-quality SEND data can trigger rejections, information requests, and costly submission delays, making robust verification and traceability essential. Managing SEND conversion in-house places significant burden on...
by Instem Team | Jun 3, 2026 | Resources
Preclinical animal facilities face mounting pressure to maintain animal welfare, ensure regulatory compliance, and uphold data integrity, all while supporting the diverse timelines and priorities of multiple research teams. Yet many facilities continue to rely on...
by Instem Team | Jun 2, 2026 | Resources
Pharmaceutical and biotechnology laboratories depend on a wide array of analytical instruments, each operating as an independent data environment with its own file storage, user access controls, and audit trail configurations. Without centralized governance across...
