{"product_id":"ims-biosciences-gmp-iso-9001-iso-22301-iso-31000-alcoa","title":"IMS Biosciences (GMP, ISO 9001, ISO 22301, ISO 31000, ALCOA+)","description":"\u003cp\u003eThis Integrated Management System is engineered for biosciences and biotechnology organizations that must reconcile Good Manufacturing Practice with modern ISO discipline. It fuses GMP process control, ISO 9001 quality management, ISO 22301 business continuity, ISO 31000 risk management, and ALCOA+ data-integrity principles into one coherent, audit-ready framework. Rather than maintaining five disconnected systems, your team works from a single Quality Manual, harmonized procedures, and cross-referenced records that eliminate duplication and contradiction. The kit delivers everything needed to operationalize compliance from day one: controlled procedures for manufacturing, deviation and CAPA handling, change control, and supplier qualification; validated forms and records that enforce attributable, legible, contemporaneous, original, and accurate data capture; checklists that convert regulatory clauses into daily practice; and training material that builds staff competence and demonstrates it to auditors. Designed for regulatory inspections by GMP authorities and third-party ISO certification bodies alike, it shortens implementation from months to weeks. Each document is professionally written, logically numbered, and immediately customizable to your products, sites, and organizational structure. Whether you are a start-up preparing for your first inspection or an established firm consolidating fragmented systems, this suite provides the governance backbone, the data-integrity safeguards, and the resilience planning that regulators now expect. The result is a defensible, transparent, and continuously improving quality culture — reducing compliance risk, protecting product quality, and accelerating market access while lowering the cost and effort of maintaining certification.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eIncluded:\u003c\/strong\u003e 31 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":56517066031444,"sku":"AGS-09-008","price":2800.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1052\/4996\/4372\/files\/IMS-Biosciences-GMP-ISO-9001-ISO-22301-ISO-31000-ALCOA.png?v=1784574573","url":"https:\/\/agskits.com\/products\/ims-biosciences-gmp-iso-9001-iso-22301-iso-31000-alcoa","provider":"apex global solutions","version":"1.0","type":"link"}