S.I.A. is able to produce pharmaceutical documentation related to any lifecycle study (Requirements, Validation Plan, P&I, I/O List; Specifications, Protocol Plan and Test Execution, etc. up to End of Validation Report and System Disposal).
S.I.A. knows the 21 CFR part 11, applies it and has its own achievements in this area, repeatedly verified by regulatory bodies.
All of this is regulated by a procedural system that guarantees homogeneity, clarity and comprehensibility.
The department is responsible for:
This area provides for the preparation of the Communication List according to the I/O List. This area also follows the informal “in progress” verification of the suitability of the code to perform the required functions. The deep knowledge of the code makes the Programmer’s contribution essential in the preparation of the Factory and Field Software Test Plan, where essentially the method of execution and expected results are indicated. The members of this department carry out the tests, in order to verify the correct functioning of the machine, on protocols verified by the QA and approved by the Technical Director. Our technicians are particularly experienced in Siemens (S5, S7, Desigo) and Rockwell PLC software.
The SCADA area provides:
Members of this department conduct testing so that the supervisory system is functioning properly on protocols verified by QA and approved by the technical director.
We are integrators of market leading systems such as GE iFix, WinCC, Ignition, Wonderware.
The Information Technology area is dedicated to the management and preservation of corporate SW with particular attention to cyber security and data protection. Our Microsoft and Nozomi certified technicians deal with virtualisation, design and implementation of networks, server configuration, access control and protections. Internally they distribute working copies, organise backups.
The software section develops applications and plug-ins in compliance with 21 CFR PART 11 and Annex 11 of the GMP to give more efficiency to SCADA or to interface in optics Industry 4.0 the machines with MES systems.
An internal team is in charge of validating the software according to the regulations required in the pharmaceutical and food sectors.
Within the industry there may be three different professional figures who are entrusted with different tasks:
All individuals have in-depth knowledge of GMP regulations, GAMP guidelines, the concept of Data Integrity, and 21 CFR part 11 regulations for assessing compliance of systems with electronic records and/or signatures.
We believe that a project does not end after commissioning, SIA’s Service division allows us to assist the customer over time to support him in any need.
We provide our customers with telephone numbers and accounts dedicated to requesting assistance even 24 hours a day 7 days a week.
We are able to close assistance tickets in a very short time with the support of dedicated development teams.