Process industry & regulated industries

Process Industry & Regulated Sectors: IT Solutions for the Process Industry & Regulated Sectors IT solutions for the process industry comprise integrated systems combining ERP (Enterprise Resource Planning), Maintenance, Industrial IoT, Data Analytics and generative AI, which comprehensively control, document and ensure the traceability of batch- and recipe-based production in regulated sectors such as chemicals, pharmaceuticals, life sciences and medtech. collana provides these building blocks from a single source: based on Microsoft technology, with its own maintenance software and with generative AI within a proven framework. The promises made on this page are backed up by published projects, including those at REMONDIS BURCU and Bucher Municipal. Here you will find an overview of the six solution modules; the linked product and solution pages provide more detailed information. Discover solutions What regulated industries demand from their IT In the process industry, regulatory requirements determine the IT architecture. Anyone manufacturing for the pharmaceutical, life sciences, chemical or medtech sectors must map complex quality processes and document and verify every process step. Requirements such as those set by the FDA or REACH therefore determine how systems collect, store and verify data. In concrete terms, this means: traceability of batches, quality data and supply chain processes; data integrity with electronic audit trails; CSV- and GAMP-5-compliant validation of the systems used; and audit-ready, documentation-mandated processes during ongoing operations rather than post-process documentation. It is precisely on these points that siloed solutions fail in many organisations: When ERP, maintenance, laboratory and production data are stored in separate systems, every audit becomes a manual search. An integrated architecture makes compliance requirements a built-in feature of the system, rather than an afterthought. For IT management and the CFO, this means: the question is not whether a single tool meets a requirement, but whether the system landscape as a whole is consistently documented. To put this into context: this page covers IT and software solutions for process manufacturing, i.e. production based on recipes and in batches. For discrete manufacturing involving bills of materials and individual parts, there is a separate overview for Production & Discrete Manufacturing. Discover our solutions: Challenges & Benefits, Products, Case Studies. Six solution building blocks: from ERP to generative AI. collana covers IT for the process industry with six building blocks: Microsoft Dynamics 365 F&SCM, bespoke software development, collana maintool, Industrial IoT Architecture, Data Analytics & Business Intelligence, and generative AI in enterprises. All six run on Microsoft technology and are seamlessly integrated. This saves you the hassle of integrating multiple vendors and keeps process and quality data within a single, end-to-end system landscape. ERP for the process industry: Microsoft Dynamics 365 F&SCM Microsoft Dynamics 365 Finance & Supply Chain Management (F&SCM) maps batch- and recipe-based processes out of the box, including 360° traceability of batches, quality data and supply chain processes, electronic audit trails, and CSV- and GAMP 5-compliant validation. The ERP software thus forms the basis for FDA, EMA or REACH/CLP compliance documentation. Full details, from quality management to validation support, can be found on the product page for Microsoft Dynamics 365 F&SCM for the process industry. REMONDIS BURCU demonstrates how this works effectively in a regulated environment: the waste management provider has been operating with an end-to-end ERP system based on Microsoft Dynamics 365 Finance & Operations on Microsoft Azure, including integrated CRM functions, since its go-live in 2021. Costs and revenues can be tracked at any time at batch and project level, and the industry-specific implementation has led to high levels of system acceptance. The project was implemented within the collana Group (b4dynamics). Read the REMONDIS BURCU case study. Custom software development: interfaces rather than siloed solutions No off-the-shelf system covers every complex, evolved system landscape. At collana, custom software development therefore also means: interfaces and APIs that connect legacy systems to the Microsoft stack, so that data does not have to be maintained multiple times. Not an off-the-shelf product, but a targeted extension where the standard ends. This ensures your existing software remains usable and becomes part of an integrated architecture rather than yet another silo. Maintenance with collana maintool: Plant availability is a compliance issue in the process industry, as maintenance must also be fully traceable. collana maintool digitises maintenance, inspection and repair processes, documenting them automatically, comprehensively and in a way that is accessible at any time. This includes: automated maintenance planning; digital documentation with a complete plant and maintenance history; fault reports and spare parts management, also accessible via mobile devices. The software is fully integrated into the ERP system and runs on Microsoft Dynamics 365 Business Central. Find out more on the collana maintool product page. Industrial IoT: Real-time plant data Connected plants provide the data foundation upon which both efficiency and compliance requirements are based. The IoT analytics platform from Bühler AG demonstrates just how far this can go: Millions of telemetry data points, captured via Azure IoT Edge, analysed in Azure Data Explorer and evaluated in role-based dashboards. The results show up to 48 per cent less downtime, 49 per cent fewer faults and 18 per cent lower energy consumption. For regulated production, one thing matters above all: the same data set that makes availability and energy usage transparent also underpins quality and compliance processes. The full story is documented in the Bühler AG case study. Data Analytics & Business Intelligence: turning process data into decisions Captured data is only of value when it supports decision-making. Data analytics and business intelligence make quality and process data suitable for reporting and auditing: a shared database as a single source of truth, dashboards for production, quality and management, and analyses that stand up to scrutiny in audits. This not only simplifies reporting to regulatory bodies and customers but also highlights deviations at an earlier stage. The Bühler case study mentioned above demonstrates how analytics and IoT work together; the ‘Data & BI’ solution overview brings together all the analytics components. Generative AI in business: making documented knowledge usable Generative AI is used by collana wherever documented knowledge is needed in day-to-day operations. One published example is Bucher Municipal: an AI chatbot based on Azure OpenAI Service and Azure AI Search makes maintenance and service knowledge available to technicians worldwide in multiple languages, including German, Spanish and Chinese. Technicians can find the knowledge they need more quickly, which shortens diagnosis and repair times and reduces downtime and operating costs. The project was implemented within the collana Group (Option 4.0) in collaboration with Bucher Municipal. See the Bucher Municipal case study. For regulated industries, data protection is paramount – and this must be a concrete measure rather than a blanket promise: data processing takes place in compliance with the GDPR within your organisation’s Azure environment, without access by external providers, and is secured via encryption, role-based access controls and Azure Key Vault. Where data must not leave the premises at all, offline AI and local LLMs are the alternative. Find out more on the details page for generative AI in Azure. ERP for the process industry: Microsoft Dynamics 365 F&SCM Microsoft Dynamics 365 Finance & Supply Chain Management (F&SCM) maps batch- and recipe-based processes out of the box, including 360° traceability of batches, quality data and supply chain processes, electronic audit trails, and CSV and GAMP-5-compliant validation.

MEGA BASIM: Digital printing processes from a single source

MEGA BASIM: Seamless digital printing processes Home / MEGA BASIM: Seamless digital printing processes The project at a glance 8 months to go-live It took just eight months from selection to full ERP implementation – including PrintVis integration. 40% of exports digitally managed Thanks to the centralised ERP platform, orders can be processed efficiently on an international scale. Significantly improved data quality following implementation All departments now work with an integrated database – ensuring greater control, transparency and productivity. Sector Services / Media Client MEGA BASIM YAYIN SAN. VE TIC. A.S. Technology / Product Microsoft Dynamics NAV 2012, PrintVis, TARGIT BI, MAS and Web CRM integrations Project description The challenge MEGA BASIM has been active in the printing industry since 1991 and faced the challenge of consolidating numerous separate systems, which lacked interfaces, into a single integrated solution. The existing processes were heavily paper-based, departments worked in isolation from one another, and there was a lack of transparency regarding quotations, orders and reports. The complex requirements arising from bespoke print orders necessitated a central ERP system that was industry-specific, flexible and future-proof. Solution The implementation MEGA BASIM opted for Microsoft Dynamics NAV 2012 in combination with the PrintVis printing solution. In collaboration with b4dynamics (a member of the collana Group), an industry-specific approach was adopted: sales, production, warehousing, procurement, costing and accounts were consolidated into a single solution.  PrintVis provided functions such as preliminary costing, pricing and machine integration. The system was supplemented by TARGIT for business intelligence, as well as MAS and web CRM interfaces. The new system went live after just eight months. „The biggest step in institutionalisation is the switch to an ERP system and its successful implementation. Many thanks to the b4dynamics team for making this possible. If I were to undertake a new ERP project in another company, I would choose b4dynamics again. This software and the b4 team have done an excellent job!“ Adem Tekşen, Finance Manager, MEGA BASIM Result / Impact How the problem was solved With the introduction of Dynamics NAV and PrintVis, MEGA BASIM’s entire organisation was digitised and centralised. Today, all departments work with a shared database. Customer enquiries can be answered more quickly and reliably. The automation of processes and the high data quality have significantly improved operational efficiency. The system’s user-friendliness has also ensured a high level of acceptance amongst the team. Business management is now based on valid data and specifically supports international growth. Recommendation: Customers were also interested in using data analytics to efficiently analyse printing processes and make the right decisions. Find out more Find the right system solution for your business model in the ERP workshop. Find out more Map specific requirements and optimise existing systems with bespoke software. Find out more The best choice for digital production control MEGA BASIM optimises its printing processes with Dynamics NAV and PrintVis – in an integrated, international and efficient manner.

Berteks Tekstil: An ERP for 100 years of textile tradition

Berteks Tekstil: An ERP system for 100 years of textile tradition Home / Berteks Tekstil: An ERP system for 100 years of textile tradition The project at a glance A single database for all departments Centralised data management significantly improves coordination between accounts, production and management. More efficient processes through adherence to standards The ERP implementation took place without the need for unnecessary in-house development – saving time and costs in the long term. Well-informed decisions in real time Thanks to integrated reporting modules, management receives reliable data for strategic decision-making. Sector Production and manufacturing Client Berteks Tekstil A.Ş. Technology / Product Microsoft Dynamics AX 2012 (Business Value) Project description The challenge As a long-established textile company with over 100 years of history, Berteks was using several local software systems that were neither interconnected nor future-proof. Departments such as accounts, HR and sales were working with different data sources, which led to conflicting reports, inefficient processes and an increased risk of errors. The aim was to introduce a modern, comprehensive ERP solution that would create transparency, simplify processes and strategically support growth. Solution The Implementation Together with b4dynamics (a member of the collana Group), Berteks implemented Microsoft Dynamics AX 2012 as an integrated ERP solution. The roll-out followed a clear best-practice approach that deliberately avoided unnecessary customisation. This made it possible to overcome the negative experiences associated with overly customised legacy systems. The system now digitally maps all core processes – from production through cost accounting to reporting.  The project was supported by targeted training and close project management to successfully familiarise staff with the new system logic. „With AX 2012, we have integrated all our processes – our company now operates more efficiently and quickly. Microsoft is one of the three largest software providers worldwide, and b4dynamics takes a strong, international and practical approach. The positive feedback from other textile companies reinforced our decision to choose b4dynamics.“ Berk Noyan, Project Manager, Berteks Tekstil A.Ş. Result / Impact How the problem was solved With the new ERP platform, Berteks was able to significantly modernise its internal processes. All departments now access a shared database, which has greatly improved internal coordination, reporting and analysis. The digital solution forms the basis for well-informed management decisions, efficient processes and continuous quality improvement. Thanks to the implementation, which closely follows the standard configuration, Berteks also benefits from a low-maintenance, future-proof system landscape. Recommendation Customers were also interested in: Consolidating financial processes and making informed decisions with Microsoft Dynamics 365 Finance. Find out more: Gain clarity on requirements and find the right solution in the ERP workshop. Find out more: Analyse real-time data and manage production effectively with Data Analytics. Find out more: The best choice for process reliability in the textile industry. Using Dynamics AX 2012 and a best-practice approach, Berteks has modernised its ERP landscape – making it efficient, integrated and geared towards growth.

Digital maintenance with maintool at GSB Bayern

Digital maintenance with collana maintool at GSB Bayern Home / Digital maintenance with maintool at GSB Bayern The project at a glance 4 hours of manual work saved per week Paper-based maintenance planning replaced by maintool Complex plant digitised Plant- and location codes fully imported from Excel Mobile access via app Easy to use via the movatix app from Tegos Sector Energy and Environment / Hazardous waste disposal Client GSB Hazardous Waste Disposal Bavaria GmbH Technology / Product collana maintool (CMMS solution, integrated with Microsoft Dynamics NAV) Project description The challenge As Europe’s largest hazardous waste disposal operator, GSB operates a highly complex technical infrastructure with strict inspection and maintenance requirements. The maintenance management software previously in use was outdated and paper-based. Every week, four hours were spent solely on the manual preparation and distribution of maintenance orders. The aim was to introduce a modern, integrated system for digital maintenance – fully compatible with Dynamics NAV. Solution: Implementation GSB opted for collana maintool as its central maintenance tool – implemented by Tegos Rosenheim. All asset identifiers, location data and inspection schedules were imported from Excel. The user interface was specifically tailored to the requirements of the technical services and engineering teams. In addition, movatix, Tegos’s mobile app solution, is used for easy operation directly on site. This gives technicians access to relevant tasks and information at all times. „Now, with maintool, it’s a huge advantage that this data is linked to the tasks. Maintenance tasks and recurring inspections are directly linked to the respective asset.“ Katja Zeller, Engineer, GSB Result / Impact How the problem was solved With collana maintool, GSB has centralised, digitised and made its maintenance processes more transparent. Managers receive reliable information for tracking and ensuring compliance, whilst technicians can work more efficiently and with greater predictability. The structured assignment of tasks to assets improves data quality and simplifies maintenance planning. Mobile access via movatix rounds off the system and ensures greater efficiency, security and business continuity. Recommendation Customers were also interested in using collana maintool to digitise maintenance processes and proactively manage maintenance workloads. Find out more: Lay the foundations for a future-proof system landscape in the ERP orientation workshop. Find out more: Analyse, optimise and automate processes with Azure-based AI solutions. Find out more Best Choice for sustainable plant safety: GSB plans and documents its maintenance with collana maintool – efficiently, digitally and with a view to the future.

Efficient maintenance with maintool at IOI Oleo

Efficient maintenance with collana maintool at IOI Oleo Home / Efficient maintenance with maintool at IOI Oleo The project at a glance Two sites, one system: maintool in use in Witten & Wittenberge – seamlessly integrated Rapid implementation in 3 months Complete system changeover with high acceptance levels Fault and inspection management digitised Recurring tasks and budget processes managed centrally Sector Chemical and raw materials industry Client IOI Oleo GmbH Technology / Product: collana maintool (maintenance solution, integrated with Microsoft Dynamics NAV) Project description The task Following a change of ownership, IOI Oleo faced the challenge of migrating all maintenance processes from SAP to a new ERP system. The previous combination of SAP and Access databases was neither consistent nor sustainable in the long term. The company was looking for a user-friendly and future-proof solution that would meet all requirements relating to mandatory inspections, deadline tracking, budget control and procurement integration, and that could be integrated into Navision. Solution: Implementation The choice fell on collana maintool – recommended by the reference client Walter Rau. In Witten, the solution was implemented within three months. Even staff experienced with SAP quickly found their way around the system. At the second site in Wittenberge, a complete new implementation took place, including interfaces for procurement, budget management and quotation preparation. Key users guided staff through the implementation, supported by customised processes. Since then, faults, recurring tasks and budgets have been managed centrally via collana maintool. „It was exciting to teach our colleagues a completely new programme. Thanks to Nils Brockmüller, project manager at collana apps, implementation was swift.“ IOI Oleo project team Result / Impact How the problem was solved The roll-out of collana maintool has significantly simplified maintenance processes at IOI Oleo. Maintenance and inspection requirements are reliably documented, budgets are planned more effectively, and faults are dealt with efficiently. The entry of item characteristics ensures high data quality and traceability. Another advantage: work order requirements can be documented directly. Recommendation Customers were also interested in using collana maintool to digitise maintenance processes and proactively manage maintenance costs. Find out more Lay the foundations for a future-proof system landscape in the ERP orientation workshop. Find out more Analyse, optimise and automate processes with Azure-based AI solutions. Find out more Best Choice for transparent maintenance: IOI Oleo manages maintenance and inspections reliably – with collana maintool as a stable foundation.

International BI platform with TARGIT at Beckhoff Automation

An international BI platform based on TARGIT and Microsoft technologies was set up for Beckhoff.
More than 300 users are working with the solution in over eleven countries. Data from Microsoft Dynamics 365 Finance & Operations, as well as historical ERP data, is analysed centrally. The purchasing, warehousing, production and dispatch departments receive up-to-date key performance indicators and are increasingly able to carry out their own analyses.

Inselspital Bern digitises stem cell therapy with MARCELL

Inselspital Bern is digitising stem cell therapy with MARCELL Home / Inselspital Bern is digitising stem cell therapy with MARCELL The project at a glance 10+ years in use The „MARCELL“ solution has been supporting the clinic’s day-to-day operations for over a decade. FACT-JACIE-compliant documentation and quality control in accordance with internationally recognised standards. HL7 integration Seamless connection to Inselspital’s clinical information system. Sector Pharmaceutical industry and healthcare Client Inselspital, University Hospital of Bern Technology / Product MARCELL web application, HL7 integration, label generation, PDF documentation © Insel Group Project description The task In the field of stem cell transplantation, Inselspital Bern faced the challenge of digitising complex administrative and organisational processes that were previously paper-based. The new solution was required to comply with the strict FACT-JACIE guidelines whilst also being flexible enough to adapt to new medical findings – whilst ensuring maximum security and traceability. © Insel Group Solution Implementation collana solutions AG developed the web application „MARCELL“, which reliably meets all the requirements of stem cell therapy. It enables structured data capture and comprehensive quality control in accordance with FACT-JACIE standards. Technical highlights of the solution include HL7 integration into the clinical information system, ISBT128-compliant label generation and the automatic creation of PDFs for all relevant documents. In addition to development, collana solutions AG also took on maintenance and support, including ongoing development to ensure long-term usability. „Close collaboration with the client was crucial to understanding and accurately implementing the requirements and their complexity in relation to the international JACIE quality standard for cell therapy. The result is an application that meets the high quality and regulatory standards and is designed for use in an accredited environment for autologous stem cell transplantation in patient care.“ Romano Coduri, Senior Consultant, collana solutions AG © Insel Group Result / Impact How the problem was solved With „MARCELL“, Inselspital Bern now has a durable, flexible and future-proof solution for the sensitive field of stem cell transplantation. The application enhances compliance with international quality standards, reduces sources of error and enables continuous development in line with medical advances. An example of digital excellence in healthcare. Recommendation: Customers were also interested in using ‘collana med’ to efficiently manage clinical processes and digitally map the entire day-to-day running of the hospital. Find out more Gain clarity on requirements and find the right solution in the ERP workshop. Find out more Comprehensively manage social care organisations digitally with collana care – from HRM to care planning. Find out more Best Choice for medical precision Digitalisation at the highest level – for standards you can rely on.

maintool

Maintenance software that prevents downtime Integrated with Microsoft Dynamics 365 Request a live demo Book a consultation Home Key Facts Comparison Case Studies Pricing Technology used FAQs maintool – Maintenance software When maintenance is carried out on an ad hoc basis, you end up paying more A piece of equipment has come to a standstill. The technician searches through a file folder for the latest maintenance log. The Excel spreadsheet from the shift supervisor is three weeks old. Nobody knows exactly when the spare part was last ordered. Maintenance is still planned manually: in Excel spreadsheets, on paper or on an ad hoc basis. collana maintool plans automatically. Maintenance intervals, notifications and responsibilities are managed digitally and reliably. Plant downtime leads to unplanned costs and production losses. collana maintool detects faults at an early stage and significantly reduces downtime. Documentation takes time, is a source of frustration and is rarely complete when it’s needed. collana maintool documents automatically, comprehensively and makes records accessible at any time. Sound familiar? Maintenance on an ad hoc basis is expensive. Unplanned downtime has a direct impact on production, delivery reliability and profit margins. A proliferation of Excel spreadsheets, incomplete documentation and a lack of real-time insight into plant condition become a burden during every audit. They also pose a risk during every audit under ISO 9001, GMP or MDR. Modern maintenance software solves precisely that. That’s why you can trust us Key Facts 6-time Microsoft Solutions Partner 40+ years of maintenance know-5% Increase machine utilisation 1,000+ customers in the collana Group Target audience: SMEs and large enterprises Markets: International Technological basis: Microsoft Dynamics 365 Business Central with extensions in AL Constant maintenance lists, unexpected downtime, lack of transparency? That’s exactly what collana maintool was developed for. The app extends Microsoft Dynamics 365 Business Central with digital maintenance functions – from planning through to execution and documentation. maintool is used by medium-sized and large industrial companies that want to ensure their asset availability and automate processes. If you want to manage your maintenance centrally and actively prevent downtime: collana maintool is ready. Get a free consultation now Download now from AppSource collana maintool vs. traditional maintenance The biggest difference between collana maintool and traditional maintenance management lies in its full integration with Microsoft Dynamics 365 Business Central. Many processes that would otherwise be carried out manually or via external tools are automated and managed centrally within the ERP system. Here is an overview: collana maintool Manual maintenance Automated maintenance planning Digital documentation and history Integration with Microsoft Dynamics 365 Mobile use and cloud access Real-time transparency across all assets What maintenance software does – explained briefly Maintenance software is a digital platform for the planning, control and documentation of all maintenance, inspection and repair processes for machinery and plant. It combines asset registers, order processing, spare parts management and KPI reporting in a single system – making it the operational backbone of modern maintenance. Three variants are distinguished in the market: Variant Focus Strength Weakness CMMS (Standalone) Pure maintenance management Quick to get up and running Stand-alone solution, separate data master EAM Asset lifecycle, often with financial data Comprehensive overview of assets Dedicated platform, integration effort required ERP-integrated (collana maintool) Maintenance within the ERP data model A single database: maintenance, procurement, finance, warehousing Prerequisite: ERP strategy based on Dynamics 365 Anyone wishing to rely on a consistent data environment in the long term cannot avoid the ERP-integrated approach. See maintool Live’s results: measurable ROI We do not measure maintenance software by its features, but by key performance indicators, measurable efficiency and process improvements. In our clients„ projects – and in cross-sector studies – we see consistent results: up to 30–50 % fewer unplanned downtimes through preventive and condition-based maintenance. (McKinsey, “Manufacturing’s Next Act”) Up to 25 % reduction in spare parts stock whilst simultaneously increasing equipment availability, as criticality and consumption become transparent. Audit compliance for ISO 9001, GMP (pharmaceuticals) and MDR (medical technology). Maintenance history, calibrations and approvals are documented in an audit-proof manner. Longer equipment service life and reduced follow-up costs through consistent root cause analysis rather than merely addressing symptoms; at the same time, maintenance costs can be reduced by 10–30 %. (McKinsey) Faster order processing with shorter lead times thanks to digital planning and tracking. Reduced workload for management: automated workflows and centralised documentation significantly reduce administrative effort; case studies estimate time savings of several hours per technician per week. We’ll provide specific recommendations for your setup during a 30-minute preliminary consultation. Features that make a difference in day-to-day operations: we group features by benefit, not by module: Automated maintenance planning – preventive, reactive and condition-based, with a drag-and-drop planning board, shift models and a reminder function for maintenance appointments. Mobile and offline order processing for technicians in the field. Work order details, instructions and checklists are available even if the cleanroom has no Wi-Fi reception. Technicians can report faults directly on site. Asset register with QR and RFID identification. Scan the asset, view its history, start the work order. QR codes provide a clear overview in a matter of seconds. Spare parts and stock management directly within the ERP system. No duplicate data records, no data transfer errors. The spare parts control function monitors stock levels and initiates reorders to ensure an up-to-date overview. Condition-based maintenance and monitoring. Equipment conditions are monitored, failures are detected at an early stage and downtime is significantly reduced. Tailored to your sector. Maintenance is sector-specific. So is our solution. Production and manufacturing: GMP-compliant documentation, condition-based maintenance, OEE transparency across plant boundaries. In the context of Industry 4.0, industrial demands for networked maintenance, transparent data flows and the digital management of complex plant technology are increasing. Particularly relevant for mechanical engineering and the pharmaceutical sector. Further details under Production & Manufacturing. Healthcare Switzerland – Medical Technology Maintenance: collana maintool documents the maintenance of medical devices comprehensively and in an audit-proof manner – meeting the requirements of MepV (Switzerland) and MDR (EU), including calibration and safety certificates. For hospitals, care centres and outpatient services, complemented by the collana Group’s healthcare expertise in Switzerland. Find out more under Healthcare. Retail and Logistics With collana maintool, you can keep warehousing, conveyor and order-picking systems running without downtime, even during peak periods – as demonstrated in the facility environment at BER Airport. Case Studies: collana maintool in practice collana maintool is a solution that has been established in the market for over 35 years and is trusted by many renowned customers across various sectors, from chemicals to logistics. Discover how smart maintenance works in practice in our case studies. Digital maintenance with maintool… Digital maintenance with maintool at Berlin Brand Airport… Read more Efficient maintenance with maintool… Efficient maintenance with collana maintool at IOI Oleo St… Read more Digital maintenance with maintool… Digital maintenance with collana maintool at GSB Bayern St… Read more Why Microsoft Dynamics 365 is the best foundation A stand-alone solution may seem effective at first, but it proves costly in the long run. That is why we base our maintenance directly on the ERP data model: a single database rather than data silos. Maintenance, procurement, finance and warehousing all work from the same data master. The centralised management of data, documents and asset objects within a shared structure ensures that information is consistent and readily accessible. Spare parts orders are triggered directly from the work order, costs are allocated to specific assets, and

Microsoft Dynamics 365 Finance & Supply Chain Management – Process Industry

The best choice for ERP in the process industry and regulated sectors. Microsoft Dynamics 365 Finance & Supply Chain Management (F&SCM) is the ERP solution for organisations where quality, compliance and traceability are business-critical. Let’s embark on the future together Home Key Facts Comparison Case Studies Implementation Technology Used FAQs Microsoft Dynamics 365 Finance & Supply Chain Management A solution for many challenges We need to meet regulatory requirements such as GxP, GAMP 5 or MDR – our current ERP system is not designed for this. F&SCM enables CSV- and GAMP 5-compliant validation and ensures audit-ready, documentable processes. Our supply chain is complex – traceability, batches, quality and compliance must all align seamlessly. F&SCM combines batch traceability, quality control and compliance data within a single integrated platform. For FDA, EMA or REACH/CLP compliance, we need complete documentation and transparency. F&SCM supports comprehensive validation documentation, traceability matrices, and functional and test documentation – including electronic audit trails. That’s why you can trust us Key facts about our industry experience with F&SCM 100% Validatable ERP processes 360° traceability of batches, quality data and supply chain processes 40 years’ ERP experience 1 integrated solution Target audience Companies in the process industry and regulated sectors Markets Germany & Turkey Sector expertise Pharmaceuticals, life sciences, chemicals, MedTech Microsoft Dynamics 365 Finance & Supply Chain Management (F&SCM) is the central ERP platform for companies in highly regulated industries. Whether in pharmaceuticals, life sciences, chemicals or medical technology: F&SCM combines global financial management, supply chain planning and quality assurance with processes that can be validated in accordance with GxP and GAMP 5. With a structured CSV-based implementation (Computer System Validation) and audit-ready processes, the solution meets the stringent requirements of the FDA, EMA, MDR and REACH/CLP. Get a no-obligation consultation now From the current state to the digital future With clear objectives, modern methods and practical approaches, we guide companies step by step on their journey to the next phase of digital transformation. CSV & GAMP 5-compliant ERP implementation Validation strategy (GxP) Traceability matrix (URS–FS–DS–tests) IQ/OQ/PQ test documentation Audit trails & processes subject to documentation requirements Change control & release management Pharmaceuticals & Life Sciences ERP Pharma GxP Pharmaceutical processes subject to validation Production & cleanroom processes FDA/EMA-compliant documentation Medical Devices / MedTech ERP implementation MDR-compliant DHR/DMR/UDI support Quality management & CAPA Chemicals & speciality chemicals REACH / CLP compliance Hazardous substances management Batch classification & laboratory processes Validation strategy (GxP) Traceability matrix (URS–FS–DS–tests) IQ/OQ/PQ test documentation Audit trails & processes subject to documentation requirements Change control & release management ERP Pharma GxP Pharmaceutical processes subject to validation Production & cleanroom processes FDA/EMA-compliant documentation ERP implementation MDR-compliant DHR/DMR/UDI support Quality management & CAPA REACH / CLP compliance Hazardous substance management Batch classification & laboratory processes Microsoft Dynamics 365 F&SCM vs. SAP S/4HANA Many companies face a choice: Microsoft or SAP? Both systems are among the very best in the ERP sector – yet there are significant differences, particularly in regulated industries such as pharmaceuticals, life sciences, chemicals and medtech. Our overview highlights where the systems differ – particularly with regard to compliance, documentation and efficiency in a validated environment. Microsoft Dynamics 365 F&SCM SAP S/4HANA CSV validation (GAMP 5) GxP-compliant process documentation Shorter implementation times & lower project costs Traceability matrix within the project Integrations with Microsoft 365 / Power Platform Case studies: F&SCM implementation in practice Microsoft Dynamics 365 Finance & SCM is a well-established solution in the market. With over 40 years’ ERP experience and several decades of industry expertise, we know how to successfully implement the software in organisations. REMONDIS BURCU: Digitalised waste… REMONDIS BURCU: Digitalised waste management… Read more Berteks Tekstil: An ERP for 100 years… Berteks Tekstil: An ERP for 100 years of the textile… Read more Dynamics 365 F&SCM Implementation Project management: How we work Fast, close to standard, successful Our implementation methodology relies on standard software and best practices rather than expensive bespoke developments. The aim: to get you up and running quickly with a pre-configured system – supported by rapid prototyping and industry-specific add-ons. Short project timelines We implement your ERP in 9–12 months. Your key users are actively working in the system from an early stage, seeing the user interface and experiencing initial successes. This makes the project tangible, transparent and process-oriented. Two tried-and-tested approach models: Classic – all phases run sequentially; the structure is clear, and the planning is simple and straightforward. Iterative – focus on standard functions and best practices. Key users start working in the system early on; data migration and integrated testing begin from the second iteration onwards. Requirements & Testing The scope of the project is clearly defined at the outset. From iteration 2 onwards, test scenarios are in place, giving you ongoing confidence. Knowledge Transfer & Support Your key users receive practical training; they later take on first-level support for end users, thereby building up in-house expertise. For second-level support, we are on hand with a reliable hotline and support contract, whilst also ensuring the continuous optimisation of your financial processes. Technology used Tech stack Platform & base programming language Cloud & infrastructure Integration & interfaces Microsoft Dynamics 365 Finance Finance & Operations platform Power Platform integration Power BI, Power Automate, Power Apps X++ Extensions/Business Logic in Visual Studio .NET / C# For integrations and extension scenarios Microsoft Azure Cloud hosting, security and scaling Lifecycle Services (LCS) for deployments & application lifecycle management REST APIs: modern ERP interfaces for third-party software OData: standard for ERP data access and analytics Dual-write & Dataverse integration: with Dynamics 365/Power Platform Business Events & Electronic Reporting: event-driven integrations Power BI EmbeddedFor reporting & analytics Microsoft Dynamics 365 Finance Finance & Operations platform Power Platform integration Power BI, Power Automate, Power Apps X++ Extensions/Business logic in Visual Studio .NET / C# For integrations and extension scenarios Microsoft Azure Cloud hosting, security and scaling Lifecycle Services (LCS) for deployments & application lifecycle management REST APIs: modern ERP interfaces for third-party software OData: standard for ERP data access and analytics Dual-write & Dataverse integration With Dynamics 365/Power Platform Business Events & Electronic ReportingEvent-driven integrations Power BI EmbeddedFor reporting & analytics Recommendation Customers were also interested in With collana maintool, companies can make the maintenance of their machinery significantly more efficient and reduce downtime. Find out more With Modern Work, make efficient use of the Microsoft environment, digitise processes and enable teams to collaborate more productively. Find out more Use Data Analytics to uncover the treasures within your own data and leverage them profitably for business success. Find out more Questions about the product FAQs Is Microsoft Dynamics 365 Finance & Supply Chain Management suitable for regulated industries? Yes. Microsoft Dynamics 365 Finance & Supply Chain Management is suitable for regulated industries such as pharmaceuticals, life sciences, chemicals and medtech. The platform supports GxP-relevant processes, offers audit trails, comprehensive documentation functions and seamless batch and serial number tracking. This enables compliance with regulatory requirements set by authorities such as the FDA and EMA. Can Dynamics 365 F&SCM be implemented in a manner that complies with CSV and GAMP 5? Yes. Dynamics 365 F&SCM is suitable for a fully documented Computer System Validation (CSV)