by Instem Team | Jul 2, 2026 | Clinical
Keeping up with regulatory compliance in clinical trials transparency (CTT) is demanding. Sponsors need to navigate overlapping, multi-jurisdictional obligations, each with distinct timelines, data formats, and requirements for confidential information1–3. This...
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 9, 2026 | Resources
Regulated labs face growing pressure to maintain accurate and audit-ready electronic records across an increasingly complex mix of instruments, systems, and data types. Without consistent audit trail coverage and no structured way to manage compliance findings,...
