The chemical-cosmetic-pharmaceutical industry is one of the most important sectors in the Italian economy, and SAM ERP2 is a latest-generation ERP system designed and developed to meet the specific needs of Italian companies operating in this sector.
Its features enable optimum management not only of administrative and commercial processes, but also of all requirements relating to the purchasing, warehousing and processing of goods, quality controls, trackability and traceability, and all the specific regulatory requirements governing the industry.
Rigor, safety and reliability, combined with ease of use, are just some of the features that make this product ideal for all chemical-cosmetic-pharmaceutical production and trading companies, whether large or small.
SAM ERP2 is a high-tech software package designed by Centro Software for complete, integrated management of chemical-cosmetic-pharmaceutical businesses.
All processes are managed in full compliance with the relevant regulations, including EUGMP, Annex11, USF FROM-Code of Federal Regulations, Title 21, part 11 (21 CFR Part 11), etc..
The SAM ERP2 system includes management of advanced logistics with the support of INDICOD “UCC/EAN-128” “SSCC” standards, and is an essential tool for validating production process quality for all products involved in the integrated supply chain.
Generation of work flows, management control, calculation of profit margins and advanced statistical processing enable companies to monitor processes, optimize flows and achieve the highest levels of competitiveness.
Features of the Centro Software Solution
For the chemical-cosmetic-pharmaceutical industry, Centro Software has developed specific functions for transformation, packaging and distribution processes, which enable them to be validated in compliance with EU GMP, Annex 11; US FDA – Code of Federal Regulations, Title 21, part 11 (21 CFR Part 11).
From demand management (forecasts, goods orders, work orders) to delivery of the finished product, SAM ERP2 generates production and purchasing plans (MRPII) and handles order management, quality control and materials management and processing all in a continuous flow.
The configuration of users and “roles” establishes the permissions and responsibilities of operators in accordance with the rules in use in the pharmaceutical industry.
The definition of product “status”, validity period and complete traceability throughout the process of transformation and distribution ensure full operational and regulatory “consistency”, while Audit Trails and electronic signature systems make it possible to unequivocally document every sensitive transaction for GMP validation.
SAM ERP2 ensures optimal synchronization between demand for and availability of products. Thanks to EDI tools and web portals, it is possible to collect operating orders in a streamlined manner. Management of the “sales forecast plan” makes it possible to program procurement (purchasing or production of finished or semi-finished products) either separately from or jointly with the real order book, even in the absence of actual orders, and with a system that is also designed to manage “delivery programs” and “open orders”.
“Closed cycle” MRP PROCESSING (MRPII PROCESSING)
This optimizes the allocation of work to company resources, with forecasting of product availability and delivery dates not only on the basis of order planning (MRP-I), but also on the basis of the actual production capacity of the company. The system therefore takes account of machines, plants, calendars, priorities and relationships between processing phases, production cells and departments or cost centers. For instant, comprehensive control, the system provides “dispatch lists” (work sequences for each production resource), analysis of “queues” and Gantt charts for each Production Order, which can also be modified graphically to change the scheduling, and to generate and save the different scheduling plans.
PRODUCTION ORDERS and MES
Full management of all phases of operational production, both in-house and on the sites of external vendors, including: production orders, picking slips and works sheets, advance checking of pickability (on the basis of batch characteristics, purity, tolerance, quality specifications, customer specifications, etc.), work phase progress, management of quarantine and approval areas, time reading, management of processing by and for third parties, and instant checking and valuation of work completed, Work In Progress, commitments and the availability of materials. The MES system enables you to check the status and use of resources (machines, plants and personnel) by means of a synoptic panel, and enables you to read production times by means of bar codes, read personnel time and attendance in order to balance hours, use graphs to conduct instant checks on the output of each resource, and monitor the maintenance of plant and machinery.
WAREHOUSE MANAGEMENT and LOGISTICS (product “under analysis”, “approved”, “rejected”)
On the basis of control plans, the system enables you to allocate the necessary technical/administrative data (batch status, purity, dates, certificates etc.) to each batch or loading unit for controlled, consistent goods handling. Thanks to integration with “advanced wireless logistics”, goods can be identified and handled by reading the bar codes, which are validated in real time by the central system: entries, shipments, withdrawals, transfers, but also inventories, checks and sampling plans, management of storage locations (Aisles/Levels/Columns) and “loading units”, as well as optimization of space, dynamic mapping of warehouses, etc.
ANALYTICAL and INDUSTRIAL ACCOUNTING, MANAGEMENT CONTROL
Detailed allocation of costs and revenues by destination, with 2 main objectives: work order accounting (which generates itemized statements by area, agent, article, etc., calculating profit margins) and cost center accounting, which collects the costs allocated to each department and calculates the costs per unit of work (gross hourly cost of personnel or plants). Accounting by business area (or division) also generates sector-specific statements by branch, production line, business division, break-even point, etc.
The Business Intelligence and DATAMINING system automatically processes the necessary summary information for monitoring and directing the entire enterprise, with immediate generation of diagrams and graphs to facilitate their analysis and interpretation. The results of these processing operations play a vital role in ensuring that management takes the best operational and strategic decisions in the various areas.
TOOLS for CONTROL, SAFETY and WORKFLOW management
SAM ERP2 contains all the necessary functions for the chemical-cosmetic-pharmaceutical industry, with particular reference to the need to be able to validate processes in accordance with the reference standards: EU GMP, Annex 11; US FDA – Code of Federal Regulations, Title 21, part 11 (21 CFR Part 11):
- User password management – Password uniqueness, minimum length, scheduled expiry date, repetition limits, possibility of freezing a user after “n” failed login attempts.
- User Login Timeout – Possibility of configuring each session with a limit on the time for which an operator can remain continuously logged into the system.
- Controlled access – Possibility of configuring security so as to grant each user controlled access to applications, plant areas, safety areas and data within their domain.
- Security System – The system administrator can set limitations for each user or group of users (**) in the individual fields of each window or on the toolbar, and decide, on a field-by- field basis, who has the right to enter, view and edit the data. You can also customize the “label” of each “screen”, setting different languages or descriptions according to the user (you can create groups for roles, e.g. “Analyst Technicians”, “Operators”, etc., and all users associated with these roles automatically inherit rules and constraints of the group and can operate with enabled functions only). The Security System also manages the signing of documents with chains of approvals (without printing).
- Digital Signature (FDA CFR Part 11 [B/11.50] regulations) – Electronic signature is based on encryption methods. CFR 21 Part 11 regulations require “signed electronic records” to contain associated information indicating the name of the signatory, the date and time of signature and the meaning of the signature (review, approval, responsibility, etc.). Electronic signatures and handwritten signatures must be connected with the respective electronic records to ensure that the signature cannot be illegally copied or transferred, or counterfeited.
- Work Flow, Tracking and Audit Trail (FDA CFR Part 11 [B/11.10] regulations) – The system Work-Flow Design & Control system (WFDC) controls the correct completion of data on the basis of company rules that overlap with standard program rules, thus managing the business flow by means of “validation” of individual work “steps”. The integrated Audit Trail system makes it possible to check who entered each item of data: user name, date and time, function used, value prior to editing, value after editing, function or software tool used. As well as monitoring the activities performed on the database, the Tracking & Auditing Control (TAC) system can generate the transmission of automated messages (to pre-set email addresses) when certain conditions arise or after certain functions have been performed. All documents used in the ERP system can be enriched with specific fields and information to help manage the workflow, and each role or user will have a “TO-DO LIST” which is automatically fed by the upstream actions. Users can navigate and perform the action assigned to them, and in turn feed the actions to be performed downstream until the process is completed.
- ADK – With the “Application Designer Kit” every company can set the rules that govern its business processes (e.g. deciding where and in what contexts electronic signature is required); they can also optimize all operating flows to increase individual productivity, as well as process safety. Every progression of a process is validated not only by electronic signature but also on the basis of pre-set rules that help the user perform the assigned task correctly. You can also manage the “date” by which each task must be completed and the “overview” of the state of progress of each individual process.