# Document management software for GMP and ISO 9001 | FastOfi > Document management with approval workflow, versions, distribution and read confirmation, external documents and audit trail for regulated plants. URL: https://fastofi.com/en/gestion-documental Quality · Document management # Document management software for regulated plants. A document management system for GMP must control the entire document life cycle: who requests it, who drafts and approves it with a signature, who read it, which version was in force on each date and when it became obsolete. FastOfi does this within the integrated management system, with a history of every change. [Create my free workspace ](https://fastofi.com/en/solicita-demo) [See the document cycle](#dm-ciclo) Life cycle ## From change request to obsolescence, without losing the thread. Each stage leaves its record with an owner, date and signature. So you can answer in minutes which version was used in a batch or who has not read a new procedure. 1. 01 ### Request Anyone can ask to create or change a document, and the request is recorded with its reason. 2. 02 ### Drafting The owner writes the new version. Sophia can propose a draft for the person to review. 3. 03 ### Review and approval The document goes through review and is approved with an electronic signature. 4. 04 ### Distribution It is sent to the roles that need to know it, and each person confirms they have read it. 5. 05 ### Effective version and history It becomes effective with its code and version; previous versions are kept with their history. 6. 06 ### Obsolescence When it is replaced or withdrawn, the previous version becomes obsolete and is no longer available for use. What an audit asks for ## The documentary evidence most often requested. These are the questions a GMP or ISO 9001 auditor usually asks about document control, and where the answer lives. | What the auditor asks | Where the evidence lives in FastOfi | |---|---| | Which version of the procedure was in force when this batch was manufactured? | Each version has its effective dates and its approval history. | | Do staff know the updated procedure? | Distribution records who it was sent to and who confirmed reading it. | | Who approved the change and why? | The request stores the reason, and the approval carries an electronic signature. | | How do you control external documents? | Standards, certificates and supplier manuals are recorded as external documents with periodic review. | | How do you prevent an obsolete version from being used? | When a new version is approved, the previous one becomes obsolete and is taken out of use. | [Integrated management system →](https://fastofi.com/en/sistema-integrado-de-gestion) Document management by industry ## The same principles, different demands. Document control is a common requirement of GMP for pharmaceuticals, cosmetics and food, and of ISO 9001. What changes are the documents audited most. ### Pharmaceuticals Manufacturing procedures, manufacturing instructions, specifications and batch records under change control. - Versioned and approved manufacturing instructions - Specification sheets with signed approval - Change control before modifying a critical document [ERP for pharmaceuticals →](https://fastofi.com/en/medicamentos) ### Cosmetics The cosmetics GMP checklist reviews the system documentation, the records and their retention. - Procedures and records with code and version - Approved labels attached to the product registration - Distribution to plant staff with read confirmation [ERP for cosmetics →](https://fastofi.com/en/cosmeticos) ### Food Cleaning and disinfection, pest control, supplier and training programs, with their records up to date. - Prerequisite programs as controlled documents - External supplier documents with periodic review - Training linked to each distributed document [ERP for food →](https://fastofi.com/en/alimentos) Frequently asked questions ## About document management. What is document management software? It is a system that controls the creation, approval, distribution, versions and withdrawal of an organization's documents, recording who performed each step. In a regulated plant it also shows which version was in force at any given time. How is it different from a shared folder? A folder stores files. A document management system controls who can approve them, records the signature, sends the document to whoever must read it, confirms the read and prevents an obsolete version from being used. Does it work for ISO 9001 and GMP? Yes. Document control is a requirement of both. FastOfi organizes documents within the integrated management system; conformity is assessed by the auditor or the authority, not by the software. Can I upload my current documents? Yes. Current documents are uploaded with their code and version, and from there changes follow the request, approval and distribution workflow. What does Sophia do in document management? Sophia can prepare a document draft with your confirmation. Review, approval and signature are always done by a person. From the blog ## Quality guides for your plant [See all →](https://fastofi.com/en/blog/tema/calidad) - [ 13 min ### Divulgación y lectura de documentos: la evidencia que más falta en las auditorías Cómo demostrar que cada persona leyó la versión vigente de lo que le aplica: público por cargo, confirmación por versión, pendientes y capacitación graduada. ](https://fastofi.com/blog/divulgacion-y-lectura-de-documentos) - [ 14 min ### Programa de auditorías internas: cómo planear el año sin improvisar Cómo armar un programa anual de auditorías internas por riesgo: universo auditable, frecuencias, auditores independientes, listas de chequeo y hallazgos. ](https://fastofi.com/blog/programa-de-auditorias-internas) - [ 13 min ### Indicadores de calidad que sirven para decidir (y los que sobran) Cómo diseñar indicadores de calidad que sirven para decidir: ficha con fórmula, fuente, meta, umbral y responsable, segregación y qué hacer si no se cumplen. ](https://fastofi.com/blog/indicadores-de-calidad-que-sirven) ## Your documents, controlled and audit-ready. Try it free for 15 days with your real procedures. [Create my free workspace](https://fastofi.com/en/solicita-demo) [Talk to a specialist](https://fastofi.com/en/solicita-demo?intent=demo)