For manufacturing companies which work in pharmaceuticals, biomedicals and other close divisions, it’s become mandatory to have IT tools which can support in a meticulous way the whole management cycle other than production process.
SORMA experiences enable to consolidate Si5 in pharmaceuticals through a version which has been improved with the aim of enforcing control and traceability of production flow and commercial distribution according to the specific rules of this area.
Pharmaceutical companies where Si5 has been brought in are significant environments and work in the international market in specific areas of pharmaceuticals, diagnostic and hospital.
Characteristics of this area and quality rules to which pharmaceutical companies should obey, have driven to extend computer procedures related to stock flows traceability of the whole production process, from raw materials purchase to manufacturing, from quality control to distribution to front-end warehouses and clients.
Si5 Integrated structure has helped , through realizing the necessary parametrizations, optimize further some characteristics which are peculiar of the original Information System (traceability, management of due date etc…)
New IT procedures have been completely carried out according to standards and operating system verification both strict and certificated by the same users before the actual release in production.
Most important characteristics introduced in Si5 for integrated management of pharmaceuticals can be resumed as following :
- complete traceability of purchase lots, production and subcontracting,
- management and storage, after material entry, of the analysis lot of the supplier (second lot)
- stock movements through radiofrequency and barcode read,
- calculation, storage and control of due date, foregoing due date, and reanalysis date in stock flows and material planning,
- warning printout of expiring materials through automatic movements of expired products in waste warehouses,
- authorizations about using stock movements reason codes by paying particular attention to expiring materials, and reanalysis ones.
- resolution and control of material collection in FEFO (First Expired First Out) and then in FIFO (First In First Out),
- launch of work orders and production lots, through management, storage and “batch record” printout, document relating to final accounting of collected materials and traceability lots which are established in the declaration of production,
- management of rework orders concerning both manufacturing materials and market expiring by using original batch,
- management of qualitative release of both purchasing and manufacturing materials,
- issuance of picking list further to complete and partial dispatching of sale orders, to set up shipments to clients and front-end warehouses,
- double control of shipment quality against sale orders starting with a “massive” picking list and then a list for each client and warehouse,
- calculation of packages in shipment based on each container, selling packages and exhibitor,
- external distributor management with automatic movement of shipments from warehouse to clients further to IT receipt and resulting unloading of materials per batch with the aim of maintaining traceability,
- Availability of printouts to certificate the pharmaceutical use of active ingredients,
- it is also possible to carry out sampling during test when lot-tag are still at 0 level (not released).
- Availability of requalification of expiring lot-tags and scrapping expired lot-tag,
- Exclusion can be activated from expired fiche planning.
Other than production and logistics, the plan of adapting to pharmaceutical needs has also involved administration and management control. In the administrative area, it has involved fiscal and management functions dealing with suspended VAT for supplying public administration. The plan relating to management control is better structured: in fact it has been carried out the management of all control information for product families, with the complete processing of income statement and calculation of contribution margin.All information related to management elements are processed in an integrated way, through parametrizations which enable to gather automatically data generated in operation subsystems. Processing is oriented to manage variation analysis by treating data both in terms of income statement and management operation analysis about cost centres and work orders. The final result is to make all management control information available, briefly but also user-friendly, through Business Intelligence features.
Audit Trail, which allows to outline each database variation regardless of which means we are using, is also available for IT traceability of both data processing and modifications.
Download the brochure “Si5 – Pharmaceutical Erp software“
