Apache-2.0🇺🇸United StatesLife sciences
Drafts an Adverse Event Reporting Policy compliant with 21 CFR 312.32 (IND safety reporting), 21 CFR 314.80 (postmarketing), and ICH E2A, with multi-jurisdictional overlays (EMA, PMDA, Health Canada). Covers seriousness/causality frameworks, expedited reporting timelines, roles, documentation standards, training mandates, and QA mechanisms. Use when drafting or updating an adverse event reporting policy, pharmacovigilance policy, AE/SAE reporting SOP, or safety reporting framework for a pharmaceutical company, CRO, biotech, or clinical research institution.
Apache-2.0🇺🇸United StatesLife sciences
Drafts U.S. clinical trial Investigator Agreements between sponsors/CROs and principal investigators or institutions for FDA-regulated drug, biologic, or device studies. Enforces 21 CFR Parts 50, 56, 312/812, ICH GCP E6(R2), HIPAA, IRB requirements, FMV/AKS payment compliance, data integrity, publication rights, IP ownership, indemnity, and audit access. Use when drafting investigator agreements, PI agreements, clinical trial site agreements, or sponsor-PI contracts; trigger keywords: investigator agreement, clinical trial agreement, PI agreement, FDA, IND, IDE, IRB, GCP, clinical research agreement, site agreement.
MITGeneralLife sciences
Conduct a GxP audit of computerized systems and processes. Covers audit planning, opening meetings, evidence collection, finding classification (critical/major/minor), CAPA generation, closing meetings, report writing, and follow-up verification. Use for scheduled internal audits, supplier qualification audits, pre-inspection readiness assessments, for-cause audits triggered by deviations or data integrity concerns, or periodic compliance posture reviews of validated systems.
MITGeneralLife sciences
Conduct a GxP audit of computerized systems and processes. Covers audit planning, opening meetings, evidence collection, finding classification (critical/major/minor), CAPA generation, closing meetings, report writing, and follow-up verification. Use for scheduled internal audits, supplier qualification audits, pre-inspection readiness assessments, for-cause audits triggered by deviations or data integrity concerns, or periodic compliance posture reviews of validated systems.
MITGeneralLife sciences
Design a compliance architecture that maps applicable regulations to computerized systems. Covers system inventory, criticality classification (GxP-critical, GxP-supporting, non-GxP), GAMP 5 category assignment, regulatory requirements traceability, and governance structure definition. Use when establishing a new regulated facility, formalising compliance across multiple systems, addressing a regulatory gap analysis, harmonising compliance after mergers or reorganisations, or preparing a site master file that references computerized systems.
Apache-2.0🇺🇸United StatesLife sciences
Drafts inspection-ready GMP standard operating procedures for regulated manufacturing. Covers document control, role accountability, process controls, deviation/CAPA handling, and records management aligned to FDA CGMP (21 CFR 210/211), Part 11, ICH Q7/Q9/Q10, WHO GMP, PIC/S, and EU GMP. Use when creating or overhauling a GMP SOP, preparing for audits or inspections, or building compliance-ready procedures. Trigger: GMP, SOP, CGMP, 21 CFR 210, 21 CFR 211, Part 11, ICH Q7, ICH Q9, ICH Q10, WHO GMP, PIC/S, EU GMP.
Apache-2.0🇺🇸United StatesLife sciences
Drafts Investigator Agreements for FDA-regulated clinical trials between sponsors and principal investigators. Covers 21 CFR Parts 50, 56, 312/812, ICH GCP E6(R2), IRB governance, data integrity, IP, indemnification, financial terms, and termination. Use when preparing clinical trial investigator agreements, site agreements, PI agreements, or sponsor-investigator contracts for drug, biologic, or device studies.