{"product_id":"ims-pharmacovigilance-who-trs-986-21-cfr-211-iso-9001-iso-22301-iso-31000-alcoa","title":"IMS Pharmacovigilance (WHO TRS 986, 21 CFR 211, ISO 9001, ISO 22301, ISO 31000, ALCOA+)","description":"\u003cp\u003eThis specialized Integrated Management System equips pharmaceutical companies and Marketing Authorization Holders to run a compliant, inspection-ready pharmacovigilance function. It integrates GMP expectations, FDA 21 CFR Part 211, ISO 9001, ISO 22301, ISO 31000, and ALCOA+ into a unified safety-governance framework covering the full drug-safety lifecycle. The documentation operationalizes adverse-event collection, case processing, expedited and periodic reporting, signal detection and management, risk-management planning, and literature monitoring. A master Quality Manual sets the safety policy and organizational responsibilities, while detailed procedures define individual case safety report handling, reconciliation, medical review, and interactions with health authorities. Validated forms and records enforce data integrity and complete audit trails so that every safety decision is traceable and defensible. Checklists mirror inspection modules used by regulators, and training material builds the qualified-person and case-handler competencies auditors expect. Business-continuity and risk components ensure the safety system keeps functioning during disruption — a growing regulatory concern. The kit is ideal for companies establishing a pharmacovigilance system master file, preparing for FDA or WHO inspection, or outsourcing oversight to a licensed partner. Every document is editable and mapped to regulatory clauses, letting you deploy a credible PV system in a fraction of the usual time. By tightening case quality, reporting timeliness, and signal governance, this suite reduces the risk of enforcement action, protects patients, and safeguards your marketing authorizations — turning pharmacovigilance from a compliance liability into a controlled, evidence-based capability.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eIncluded:\u003c\/strong\u003e 52 ready-to-use, fully editable documents (manual, procedures, forms, records, checklists, guidance and training material).\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eLicense:\u003c\/strong\u003e single-organization license; delivered electronically as a ZIP archive.\u003c\/p\u003e","brand":"Apex Global Solutions AGS","offers":[{"title":"Default Title","offer_id":56517066260820,"sku":"AGS-09-010","price":2800.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1052\/4996\/4372\/files\/IMS-Pharmacovigilance-WHO-TRS-986-21-CFR-211-ISO-9001-ISO-22301-ISO-31000-ALCOA.png?v=1784574573","url":"https:\/\/agskits.com\/products\/ims-pharmacovigilance-who-trs-986-21-cfr-211-iso-9001-iso-22301-iso-31000-alcoa","provider":"apex global solutions","version":"1.0","type":"link"}