PROJECTS

Implementation and validation of warehouse management systems, and integration with the ERP system

Client: US multinational active in the production of innovative medicines for the treatment of serious diseases in cardiovascular, oncology, HIV and psychiatric care.

Sector: Pharmaceuticals

Objective: to implement a fully automated warehouse

Project

The client is a US multinational operating in the production of innovative medicines for the treatment of serious diseases in cardiovascular, oncology, HIV and psychiatric care. The company’s Italian branch is one of the most important and strategic branches on the entire European continent.

The company needed to implement a fully automated warehouse. The project required the involvement of several multifunctional (Engineering, Production, Laboratory, IT, etc.) and multinational (mainly USA) working groups.

The new system, in addition to being compliant with regulatory requirements, had to be integrated with the other software already present in the company, including the ERPsystem.

Our contribution

The company entrusted the project to the S4BT CSV Team, selected, both, for the high degree of professionalism – experienced by the client on previous occasions – and for our specific expertise in Project Management, Validation of Information Systems as well as the ERP system used by the client.

In the initial phase of the project, the company developed the URS (User Requirement Specification), summarised in a document containing the system requirements (process, technological, regulatory, operational, performance requirements, etc.).

At the same time, the project team defined the activity flows performed on the existing ERP system.

S4BT then elaborated the Validation Plan, i.e. the reference document for all validation activities, followed by a Risk Analysis (in accordance with FMEA methodology), to identify the critical functions relating to system implementation.

S4BT managed the Drafting and Execution of the following Protocols:

  • PC Client Installation Qualification (IQ), providing evidence of
    system installation in compliance with the hardware and software specifications of the supplier;
  • Operational Qualification (OQ) aimed at testing the correct functioning of the interfaces between the new warehouse management system and the existing ERP;
  • Performance Qualification (PQ) aimed at providing evidence of new system and
    ERP functioning in accordance with the URS document S4BT deployed human resources with skills and experience more in line with the project specifications.

Subsequently, the CSV Team developed the Traceability Matrix i.e. the document linking the URS requirements with the functions of the System controlling the Warehouse and with the Validation Protocols.

At the end of the project, S4BT prepared the Validation Report as a summary of the results of the validation activities, as well as the conclusions and recommendations for post go-live monitoring.

The activities of the CSV Team went beyond validation and integration between the two Systems.

In fact, S4BT’s contribution included Project Management activities such as drafting meeting minutes, the management and presentation of the project time lines, and coordination of suppliers and third parties.

Result

The S4BT team offered indispensable support for the completion of the project, integrating with the various actors within cross-functional and multinational teams and contributing to
the achievement of:

  • constant and real-timecontrol of the warehouse
  • reduction of storing and picking times of goods
  • zeroing of errors deriving from material handling (raw materials,
    semi-finished products, packaging, etc.)
  • possibility of “dialogue” between the warehouse and the whole company through integration with
    the ERP
  • Increase in management quality
  • Compliance with industry regulatory standards
  • Cost savings
  • Formalisation of activity flows, thanks to the preliminary study conducted by S4BT, which was previously left to subjective operator decision.
CONSULTING SERVICE ACQUIRED BY THE CLIENT COMPANY
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Project

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Projects completed in 2019
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Pharmaceutical Company

An international pharmaceutical organisation specialising in the clinical and commercial development and production of pharmaceutical products with a high degree of toxicity.

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COMPLAINTS

An aid to inspection work

Simplify the management of Complaints, from filing, through investigation, follow-up, judgment and final report.

The module is designed to provide step by step Quality Assurance support
in the implementation and supervision of the process and the assignment of tasks to the departments involved. The module supplements the CAPA procedure, which the user can open directly from the Complaints procedure.

PRAGMA-WFM documents and traces all activities and information in the Complaints process. In each phase, you can also attach files in various formats to support activities and investigations.

During inspection phases, the functionality dossier enables the real-time generation of a document that provides information and lists the activities of the process and related processes

AUDIT

Documents and traces activities

It simplifies the management of internal and external audits, from planning, through execution, to the management of remarks.

The module supplements procedures for handling CAPAs , Non Conformitiesand Change Control that the user can open directly from the audit to resolve the observations found.

PRAGMA-WFM documents and traces all activities and information of the Audit process. For each process step, it is possible to assign tasks to the people involved, and attach files in various formats.

Duringthe inspection phase, the dossierfunctioncan generate a document in real time which records the information and activities of the Audits and related processes