[\/vc_column_text][vc_empty_space height=”15px”][vc_column_text css_animation=”fadeIn”]<\/p>\n
THEMA4 APPS INTEGRATION WITH CUSTOMER\u2019S IT- NETWORK<\/strong><\/h1>\n[\/vc_column_text][vc_empty_space height=”45px”][vc_column_text css_animation=”fadeIn”]In\u00a04.0 pharma plants<\/strong>\u00a0the need for process control and electronic systems integration in the\u00a0manufacturing <\/strong>planning\u00a0is becoming increasingly important. Many functions regarding the plant data, which in the past were managed locally by manual procedure SOP, are now becoming completely\u00a0digitized with centralized management<\/strong>.[\/vc_column_text][vc_empty_space height=”60px”][\/vc_column_inner][vc_column_inner width=”1\/6″][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner offset=”vc_hidden-lg vc_hidden-md vc_hidden-sm”][vc_single_image image=”2240″ img_size=”full”][\/vc_column_inner][\/vc_row_inner][vc_empty_space height=”20px”][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” equal_height=”yes” css=”.vc_custom_1551448777969{margin-top: 60px !important;margin-bottom: 60px !important;}” el_id=”content”][vc_column width=”1\/2″][vc_column_text css_animation=”fadeIn”]To enable cost-effective operations, pharma manufacturers must think holistically about their plants to develop\u00a0integrated capabilities<\/strong>\u00a0that connect systems and processes for remaining competitive.\u00a0 This way, in the last 10 years the integration trends of pharmaceutical plants\u00a0ISA95\u00a0<\/strong>has been involving also process equipment such as\u00a0sterilization,\u00a0decontamination and washing machines.<\/strong><\/p>\nThema4 APPs<\/strong><\/h3>\nOn this perspective, Fedegari Thema4 process controller provides customers with different applications presented as optional software APPs that range from\u00a0workflow optimization<\/strong>\u00a0to\u00a0reliable integration\u00a0with clients IT-network.<\/p>\nBuilt on the Thema4 platform, these \u2018plug & play\u2019 applications allow to improve the way Fedegari process equipment is used every day and provide ever-smarter functions for achieving\u00a0business-critical performances<\/strong>\u00a0in pharma manufacturing.<\/p>\nHow to get started?<\/strong><\/p>\nChoose the Thema4 APPs that best fit your needs[\/vc_column_text][vc_empty_space][vc_gallery interval=”3″ images=”11102,11107″ img_size=”full” onclick=”img_link_large” css=”.vc_custom_1594816666378{margin-bottom: 30px !important;}”][vc_empty_space][vc_column_text]<\/p>\n
Thema4 RELIABLE INTEGRATION APPs<\/strong><\/h3>\nRecently, the planning capabilities of pharma industries have been significantly enhanced through new tools both within and on top of ERP systems. However, many companies still face difficulties on connecting systems, data compatibility, and other operational challenges. Thema4 APPs for integrated services aim to support customers in the reliable integration with their IT-network to achieve the highest performances and operate in the most cost-effective way.<\/p>\n
APP #1 \u2013 Remote GUI<\/strong>\u00a0(max 50)<\/p>\nRemote supervisory\/control and central reporting and printing.<\/p>\n
APP # 3 (OPC) and # 15 (MODBUS) \u2013 SCADA integration<\/strong><\/p>\nReal time collection\/export of production, quality and maintenance data in ER (Electronic Record): data base (tags), files (reports) and events collection for central audit trail and alarms management.<\/p>\n
APP # 6 \u2013 Automatic Backup<\/strong><\/p>\nCentralized automatic backup\/restore of machine data (disaster recovery procedure).<\/p>\n
APP # 10 \u2013 Utility Central System (UCS) Integration<\/strong><\/p>\nAPP # 11 \u2013 SNTP Clock Synchronization<\/strong><\/p>\nAPP # 16 \u2013 Remote Authentication<\/strong><\/p>\nCentral access management compliant to CFR21 part 11<\/p>\n
(central password domain control manage by Active Directory).<\/p>\n
APP # 31 \u2013 Thema4 to Database<\/strong><\/p>\nThema4 COST-EFFECTIVE OPERATIONS APPs<\/strong><\/h3>\nA proper way to manage and select programs for defined loads. These applications concern important needs and challenges faced by operators of pharmaceutical plants.The \u2018Cost-effective Operations\u2019 APPs aim to minimize errors and to guarantee reliable operations while optimizing production processes.<\/p>\n
APP # 12 \u2013 BAR CODE READER INTEGRATION<\/strong><\/p>\nFor programs selection and input of batch data; Correct selection of the program for a \u201cdefined load\u201d in order to avoid load\/machine damages.<\/p>\n
APP # 22 \u2013 ELECTRONIC SIGNATURE<\/strong><\/p>\nElectronic signature for process reports, change of parameters and cycle control.<\/p>\n
APP # 24 \u2013 PROGRAM STATUS MANAGEMENT<\/strong><\/p>\nIncreased security in program management, in order to avoid improper changes of production programs or mistakes about \u201cvalidation\u201d and \u201cproduction\u201d programs.<\/p>\n
APP # 25 \u2013 CUSTOMERS DOCUMENTS<\/strong><\/p>\nAutomatic features that help operators to assure a correct preparation of the load before running a cycle. Load description with pictures for validatable performances.<\/p>\n
The correct execution of a treatment on a defined \u201cload\u201d also depends on the operator activities during load preparation, such as:<\/p>\n
\n- How to position load\/materials into the chamber
\n\u2022\u00a0\u00a0\u00a0 Where to put temperature probes for process control and recording
\n\u2022\u00a0\u00a0\u00a0 Where to put biological indicators, if any.<\/li>\n<\/ul>\nThese activities must follow the validated approach defined for the load and documented in the customer procedure (SOP) adopted. The APP 25 \u201cCustomer Documents\u201d allows the upload of customer documents in Thema4 system. Documents are displayed in the HMI work area \u201cOnline Manual\u201d. A specific program parameter links the document to the treatment program, in order to display it after the program selection. Thema4 will permit the cycle to start only after an operator confirmation of the document viewed.[\/vc_column_text][\/vc_column][vc_column width=”1\/2″][vc_row_inner][vc_column_inner][vc_empty_space height=”60px”][\/vc_column_inner][\/vc_row_inner][vc_column_text]<\/p>\n
Thema4 \u201cPARAMETRIC RELEASE\u201d APPs<\/strong><\/h3>\nAPP # 20 \u2013 GOLDEN CYCLE PACKAGE<\/strong><\/p>\nComparison of the temperature\/pressure profiles of the executed process (using internal and\/or external selected sensors) and the user-defined \u201cideal profiles\u201d (as based on validated processes) and generation of an electronic report with comparison data in graphical and analytical format<\/p>\n
APP # 21 \u2013 PARAMETRIC RELEASE DATA TABLE<\/strong><\/p>\nAutomatic analysis during cycle execution of \u201ccritical parameters\u201d through user configurable phases and verification if the values do not exceed pre-set tolerances; generation of electronic reports with acceptance criteria (parametric release table available for SCADA and historian systems).<\/p>\n
APP # 1 \u2013 INTEGRATION WITH YOKOGAWA SERIES<\/strong><\/p>\nDX100P\/DX200P AND DX1000P\/DX2000P<\/p>\n
APP # 14 \u2013 Thema4-RECORDER<\/strong><\/p>\nExternal control system in compliance with EN285<\/a>.<\/p>\n\n- Monitor, trend, diagnose, alarm, of both \u201clocal\u201d and \u201crecorder\u201c sensors.<\/li>\n
- Data logging of recorder probes in Thema4 process report: a unique report for both systems, controller and recorder.<\/li>\n
- Fully configuration of recorder sensors to Thema4 logic numbers (TPR, TER) and to the probes lists of the programs.<\/li>\n
- Same calibration and SW-HW maintenance for both Thema4 controller and Thema4-RECORDER (by Remote GUI).<\/li>\n
- Thema4 options available also for Thema4-RECORDER: Clock Synchronization SNTP and Remote Authentication.<\/li>\n<\/ul>\n
APP # 19 \u2013 Integration with Eurotherm series 5000\/6000<\/strong><\/p>\nThema4 Additional functions<\/strong><\/h3>\nAPP # 26 \u2013 Animated P&ID<\/strong><\/p>\n![\"thema4](\"https:\/\/fedegari.com\/wp-content\/uploads\/2018\/04\/control_thema4_integrated_system_BB_USA-300x168.jpg\")
<\/strong><\/h3>\nInterested?<\/strong><\/h3>\nContact us<\/a>\u00a0for additional information on how to benefit from Thema4 APPs.<\/p>\nAbout Thema4<\/strong><\/h3>\nFirst delivered at the beginning of 2004, Thema4 is today the most reliable and fastest-developing process controller in the industry. Thema4 is defined as a completely configurable standard product (classified by GAMP5<\/a> as Category 4 \u2013 Configured Products) and is managing all industrial machines manufactured by Fedegari. This achievement is the logical consequence of almost three decades of painstaking work on process controllers combined with infrastructure investments, close collaboration with strategic partners and uncompromised values because there is no easy shortcut to durable success.<\/p>\nIn order to guarantee the highest system reliability Fedegari has chosen Wind River VxWorks<\/a> RT operating system. Over the years, collaborating with Wind River, has offered unequalled innovation opportunities impossible to be achieved alone.<\/p>\nIn order to meet the most demanding pharmaceutical requirements, great care has been taken in designing Thema4 life cycle management: from the conception phaseto components selection and definition of system architecture and project management, through the project phase in the development of software according to the FDA CFR21, part 11<\/a>, to the current operation phase and the definition of product management procedures (change control, configuration management, support, repair, maintenance, etc.) according to the \u00a0GAMP guidelines.<\/p>\n
Thema4 APPs<\/strong><\/h3>\nOn this perspective, Fedegari Thema4 process controller provides customers with different applications presented as optional software APPs that range from\u00a0workflow optimization<\/strong>\u00a0to\u00a0reliable integration\u00a0with clients IT-network.<\/p>\nBuilt on the Thema4 platform, these \u2018plug & play\u2019 applications allow to improve the way Fedegari process equipment is used every day and provide ever-smarter functions for achieving\u00a0business-critical performances<\/strong>\u00a0in pharma manufacturing.<\/p>\nHow to get started?<\/strong><\/p>\nChoose the Thema4 APPs that best fit your needs[\/vc_column_text][vc_empty_space][vc_gallery interval=”3″ images=”11102,11107″ img_size=”full” onclick=”img_link_large” css=”.vc_custom_1594816666378{margin-bottom: 30px !important;}”][vc_empty_space][vc_column_text]<\/p>\n
Thema4 RELIABLE INTEGRATION APPs<\/strong><\/h3>\nRecently, the planning capabilities of pharma industries have been significantly enhanced through new tools both within and on top of ERP systems. However, many companies still face difficulties on connecting systems, data compatibility, and other operational challenges. Thema4 APPs for integrated services aim to support customers in the reliable integration with their IT-network to achieve the highest performances and operate in the most cost-effective way.<\/p>\n
APP #1 \u2013 Remote GUI<\/strong>\u00a0(max 50)<\/p>\nRemote supervisory\/control and central reporting and printing.<\/p>\n
APP # 3 (OPC) and # 15 (MODBUS) \u2013 SCADA integration<\/strong><\/p>\nReal time collection\/export of production, quality and maintenance data in ER (Electronic Record): data base (tags), files (reports) and events collection for central audit trail and alarms management.<\/p>\n
APP # 6 \u2013 Automatic Backup<\/strong><\/p>\nCentralized automatic backup\/restore of machine data (disaster recovery procedure).<\/p>\n
APP # 10 \u2013 Utility Central System (UCS) Integration<\/strong><\/p>\nAPP # 11 \u2013 SNTP Clock Synchronization<\/strong><\/p>\nAPP # 16 \u2013 Remote Authentication<\/strong><\/p>\nCentral access management compliant to CFR21 part 11<\/p>\n
(central password domain control manage by Active Directory).<\/p>\n
APP # 31 \u2013 Thema4 to Database<\/strong><\/p>\nThema4 COST-EFFECTIVE OPERATIONS APPs<\/strong><\/h3>\nA proper way to manage and select programs for defined loads. These applications concern important needs and challenges faced by operators of pharmaceutical plants.The \u2018Cost-effective Operations\u2019 APPs aim to minimize errors and to guarantee reliable operations while optimizing production processes.<\/p>\n
APP # 12 \u2013 BAR CODE READER INTEGRATION<\/strong><\/p>\nFor programs selection and input of batch data; Correct selection of the program for a \u201cdefined load\u201d in order to avoid load\/machine damages.<\/p>\n
APP # 22 \u2013 ELECTRONIC SIGNATURE<\/strong><\/p>\nElectronic signature for process reports, change of parameters and cycle control.<\/p>\n
APP # 24 \u2013 PROGRAM STATUS MANAGEMENT<\/strong><\/p>\nIncreased security in program management, in order to avoid improper changes of production programs or mistakes about \u201cvalidation\u201d and \u201cproduction\u201d programs.<\/p>\n
APP # 25 \u2013 CUSTOMERS DOCUMENTS<\/strong><\/p>\nAutomatic features that help operators to assure a correct preparation of the load before running a cycle. Load description with pictures for validatable performances.<\/p>\n
The correct execution of a treatment on a defined \u201cload\u201d also depends on the operator activities during load preparation, such as:<\/p>\n
\n- How to position load\/materials into the chamber
\n\u2022\u00a0\u00a0\u00a0 Where to put temperature probes for process control and recording
\n\u2022\u00a0\u00a0\u00a0 Where to put biological indicators, if any.<\/li>\n<\/ul>\nThese activities must follow the validated approach defined for the load and documented in the customer procedure (SOP) adopted. The APP 25 \u201cCustomer Documents\u201d allows the upload of customer documents in Thema4 system. Documents are displayed in the HMI work area \u201cOnline Manual\u201d. A specific program parameter links the document to the treatment program, in order to display it after the program selection. Thema4 will permit the cycle to start only after an operator confirmation of the document viewed.[\/vc_column_text][\/vc_column][vc_column width=”1\/2″][vc_row_inner][vc_column_inner][vc_empty_space height=”60px”][\/vc_column_inner][\/vc_row_inner][vc_column_text]<\/p>\n
Thema4 \u201cPARAMETRIC RELEASE\u201d APPs<\/strong><\/h3>\nAPP # 20 \u2013 GOLDEN CYCLE PACKAGE<\/strong><\/p>\nComparison of the temperature\/pressure profiles of the executed process (using internal and\/or external selected sensors) and the user-defined \u201cideal profiles\u201d (as based on validated processes) and generation of an electronic report with comparison data in graphical and analytical format<\/p>\n
APP # 21 \u2013 PARAMETRIC RELEASE DATA TABLE<\/strong><\/p>\nAutomatic analysis during cycle execution of \u201ccritical parameters\u201d through user configurable phases and verification if the values do not exceed pre-set tolerances; generation of electronic reports with acceptance criteria (parametric release table available for SCADA and historian systems).<\/p>\n
APP # 1 \u2013 INTEGRATION WITH YOKOGAWA SERIES<\/strong><\/p>\nDX100P\/DX200P AND DX1000P\/DX2000P<\/p>\n
APP # 14 \u2013 Thema4-RECORDER<\/strong><\/p>\nExternal control system in compliance with EN285<\/a>.<\/p>\n\n- Monitor, trend, diagnose, alarm, of both \u201clocal\u201d and \u201crecorder\u201c sensors.<\/li>\n
- Data logging of recorder probes in Thema4 process report: a unique report for both systems, controller and recorder.<\/li>\n
- Fully configuration of recorder sensors to Thema4 logic numbers (TPR, TER) and to the probes lists of the programs.<\/li>\n
- Same calibration and SW-HW maintenance for both Thema4 controller and Thema4-RECORDER (by Remote GUI).<\/li>\n
- Thema4 options available also for Thema4-RECORDER: Clock Synchronization SNTP and Remote Authentication.<\/li>\n<\/ul>\n
APP # 19 \u2013 Integration with Eurotherm series 5000\/6000<\/strong><\/p>\nThema4 Additional functions<\/strong><\/h3>\nAPP # 26 \u2013 Animated P&ID<\/strong><\/p>\n<\/strong><\/h3>\nInterested?<\/strong><\/h3>\nContact us<\/a>\u00a0for additional information on how to benefit from Thema4 APPs.<\/p>\nAbout Thema4<\/strong><\/h3>\nFirst delivered at the beginning of 2004, Thema4 is today the most reliable and fastest-developing process controller in the industry. Thema4 is defined as a completely configurable standard product (classified by GAMP5<\/a> as Category 4 \u2013 Configured Products) and is managing all industrial machines manufactured by Fedegari. This achievement is the logical consequence of almost three decades of painstaking work on process controllers combined with infrastructure investments, close collaboration with strategic partners and uncompromised values because there is no easy shortcut to durable success.<\/p>\nIn order to guarantee the highest system reliability Fedegari has chosen Wind River VxWorks<\/a> RT operating system. Over the years, collaborating with Wind River, has offered unequalled innovation opportunities impossible to be achieved alone.<\/p>\nIn order to meet the most demanding pharmaceutical requirements, great care has been taken in designing Thema4 life cycle management: from the conception phaseto components selection and definition of system architecture and project management, through the project phase in the development of software according to the FDA CFR21, part 11<\/a>, to the current operation phase and the definition of product management procedures (change control, configuration management, support, repair, maintenance, etc.) according to the \u00a0GAMP guidelines.<\/p>\n
Built on the Thema4 platform, these \u2018plug & play\u2019 applications allow to improve the way Fedegari process equipment is used every day and provide ever-smarter functions for achieving\u00a0business-critical performances<\/strong>\u00a0in pharma manufacturing.<\/p>\n How to get started?<\/strong><\/p>\n Choose the Thema4 APPs that best fit your needs[\/vc_column_text][vc_empty_space][vc_gallery interval=”3″ images=”11102,11107″ img_size=”full” onclick=”img_link_large” css=”.vc_custom_1594816666378{margin-bottom: 30px !important;}”][vc_empty_space][vc_column_text]<\/p>\n Recently, the planning capabilities of pharma industries have been significantly enhanced through new tools both within and on top of ERP systems. However, many companies still face difficulties on connecting systems, data compatibility, and other operational challenges. Thema4 APPs for integrated services aim to support customers in the reliable integration with their IT-network to achieve the highest performances and operate in the most cost-effective way.<\/p>\n APP #1 \u2013 Remote GUI<\/strong>\u00a0(max 50)<\/p>\n Remote supervisory\/control and central reporting and printing.<\/p>\n APP # 3 (OPC) and # 15 (MODBUS) \u2013 SCADA integration<\/strong><\/p>\n Real time collection\/export of production, quality and maintenance data in ER (Electronic Record): data base (tags), files (reports) and events collection for central audit trail and alarms management.<\/p>\n APP # 6 \u2013 Automatic Backup<\/strong><\/p>\n Centralized automatic backup\/restore of machine data (disaster recovery procedure).<\/p>\n APP # 10 \u2013 Utility Central System (UCS) Integration<\/strong><\/p>\n APP # 11 \u2013 SNTP Clock Synchronization<\/strong><\/p>\n APP # 16 \u2013 Remote Authentication<\/strong><\/p>\n Central access management compliant to CFR21 part 11<\/p>\n (central password domain control manage by Active Directory).<\/p>\n APP # 31 \u2013 Thema4 to Database<\/strong><\/p>\n A proper way to manage and select programs for defined loads. These applications concern important needs and challenges faced by operators of pharmaceutical plants.The \u2018Cost-effective Operations\u2019 APPs aim to minimize errors and to guarantee reliable operations while optimizing production processes.<\/p>\n APP # 12 \u2013 BAR CODE READER INTEGRATION<\/strong><\/p>\n For programs selection and input of batch data; Correct selection of the program for a \u201cdefined load\u201d in order to avoid load\/machine damages.<\/p>\n APP # 22 \u2013 ELECTRONIC SIGNATURE<\/strong><\/p>\n Electronic signature for process reports, change of parameters and cycle control.<\/p>\n APP # 24 \u2013 PROGRAM STATUS MANAGEMENT<\/strong><\/p>\n Increased security in program management, in order to avoid improper changes of production programs or mistakes about \u201cvalidation\u201d and \u201cproduction\u201d programs.<\/p>\n APP # 25 \u2013 CUSTOMERS DOCUMENTS<\/strong><\/p>\n Automatic features that help operators to assure a correct preparation of the load before running a cycle. Load description with pictures for validatable performances.<\/p>\n The correct execution of a treatment on a defined \u201cload\u201d also depends on the operator activities during load preparation, such as:<\/p>\n These activities must follow the validated approach defined for the load and documented in the customer procedure (SOP) adopted. The APP 25 \u201cCustomer Documents\u201d allows the upload of customer documents in Thema4 system. Documents are displayed in the HMI work area \u201cOnline Manual\u201d. A specific program parameter links the document to the treatment program, in order to display it after the program selection. Thema4 will permit the cycle to start only after an operator confirmation of the document viewed.[\/vc_column_text][\/vc_column][vc_column width=”1\/2″][vc_row_inner][vc_column_inner][vc_empty_space height=”60px”][\/vc_column_inner][\/vc_row_inner][vc_column_text]<\/p>\n APP # 20 \u2013 GOLDEN CYCLE PACKAGE<\/strong><\/p>\n Comparison of the temperature\/pressure profiles of the executed process (using internal and\/or external selected sensors) and the user-defined \u201cideal profiles\u201d (as based on validated processes) and generation of an electronic report with comparison data in graphical and analytical format<\/p>\n APP # 21 \u2013 PARAMETRIC RELEASE DATA TABLE<\/strong><\/p>\n Automatic analysis during cycle execution of \u201ccritical parameters\u201d through user configurable phases and verification if the values do not exceed pre-set tolerances; generation of electronic reports with acceptance criteria (parametric release table available for SCADA and historian systems).<\/p>\n APP # 1 \u2013 INTEGRATION WITH YOKOGAWA SERIES<\/strong><\/p>\n DX100P\/DX200P AND DX1000P\/DX2000P<\/p>\n APP # 14 \u2013 Thema4-RECORDER<\/strong><\/p>\n External control system in compliance with EN285<\/a>.<\/p>\n APP # 19 \u2013 Integration with Eurotherm series 5000\/6000<\/strong><\/p>\n APP # 26 \u2013 Animated P&ID<\/strong><\/p>\n Contact us<\/a>\u00a0for additional information on how to benefit from Thema4 APPs.<\/p>\n First delivered at the beginning of 2004, Thema4 is today the most reliable and fastest-developing process controller in the industry. Thema4 is defined as a completely configurable standard product (classified by GAMP5<\/a> as Category 4 \u2013 Configured Products) and is managing all industrial machines manufactured by Fedegari. This achievement is the logical consequence of almost three decades of painstaking work on process controllers combined with infrastructure investments, close collaboration with strategic partners and uncompromised values because there is no easy shortcut to durable success.<\/p>\n In order to guarantee the highest system reliability Fedegari has chosen Wind River VxWorks<\/a> RT operating system. Over the years, collaborating with Wind River, has offered unequalled innovation opportunities impossible to be achieved alone.<\/p>\n In order to meet the most demanding pharmaceutical requirements, great care has been taken in designing Thema4 life cycle management: from the conception phaseto components selection and definition of system architecture and project management, through the project phase in the development of software according to the FDA CFR21, part 11<\/a>, to the current operation phase and the definition of product management procedures (change control, configuration management, support, repair, maintenance, etc.) according to the \u00a0GAMP guidelines.<\/p>\nThema4 RELIABLE INTEGRATION APPs<\/strong><\/h3>\n
Thema4 COST-EFFECTIVE OPERATIONS APPs<\/strong><\/h3>\n
\n
\n\u2022\u00a0\u00a0\u00a0 Where to put temperature probes for process control and recording
\n\u2022\u00a0\u00a0\u00a0 Where to put biological indicators, if any.<\/li>\n<\/ul>\nThema4 \u201cPARAMETRIC RELEASE\u201d APPs<\/strong><\/h3>\n
\n
Thema4 Additional functions<\/strong><\/h3>\n
<\/strong><\/h3>\nInterested?<\/strong><\/h3>\n
About Thema4<\/strong><\/h3>\n