Sustainability Archive | Experts Institut

CSRD in the omnibus procedure: Basics, terms and what companies should know now

The Corporate Sustainability Reporting Directive (CSRD) has significantly increased the demands placed on sustainability reporting by companies. Many organizations are currently faced with the question: What does CSRD actually mean – and what is the omnibus procedure all about?
This article provides an understandable introduction to the basics, classifies key terms and shows why there is a need for action, even if not all details have been finally clarified.

What is the CSRD – and why does it affect so many companies?

The CSRD is an EU directive that obliges companies to report comprehensively, comparably and verifiably on sustainability. The aim is to integrate environmental, social and governance (ESG) aspects more strongly into business decisions and external transparency.

Compared to previous regulations (e.g. NFRD), the scope of application is significantly wider:

more companies subject to reporting requirements
deeper content requirements
Stronger auditing and documentation obligations

CSRD is therefore no longer just a reporting issue, but touches on management, processes, IT and governance.

The omnibus procedure: Why the rules are evolving

The so-called omnibus procedure describes adjustments and bundling of regulatory requirements at EU level. The CSRD and the associated ESRS (European Sustainability Reporting Standards) are also affected by this.

For companies, this means

The objectives and structure of the CSRD are clear
Detailed designs continue to evolve
Individual requirements are specified or sharpened

Despite this dynamic, the implementation obligation remains. Waiting is therefore not an option – what is needed is a pragmatic approach to uncertainty.

Key terms briefly explained

Double materiality analysis

Companies must evaluate:

Impact materiality: What impact does the company have on the environment and society?
Financial materiality: Which sustainability issues have an impact on the financial situation?

This analysis forms the basis for the content of CSRD reporting.

ESRS compared to CSRD

The European Sustainability Reporting Standards (ESRS) specify the content that companies must report and how this information must be prepared. They define key figures, qualitative information, the structure and level of detail of sustainability reporting and make it comparable and verifiable throughout Europe.

The CSRD (Corporate Sustainability Reporting Directive), on the other hand, is the overarching legal framework. It determines who is obliged to report, when reporting is required and under what legal conditions. The CSRD therefore provides the legal framework, while the ESRS fills out this framework in terms of content.

In short: The CSRD requires reporting – the ESRS explain how it is to be implemented in practice.

Scope 1, 2 and 3

Scope 1 – direct emissions: Emissions from own or controlled sources, e.g. from company-owned heating systems, production processes, emergency generators or the company’s own vehicle fleet
Scope 2 – indirect emissions from energy: emissions from the generation of purchased energy, such as electricity, district heating, steam or cooling, which are used in the company
Scope 3 – Emissions along the entire value chain: All other indirect emissions, e.g. from purchased raw materials, transportation and logistics, employee commuting, use and disposal of products or from upstream supply chains

Scope 3 in particular poses major operational challenges for many companies.

Why Scope 3 is so complex – and at the same time so relevant

Scope 3 emissions make up the largest part of the carbon footprint in many industries. At the same time, the relevant data is often outside the direct sphere of influence, for example at suppliers or logistics partners.

Typical challenges:

Different data quality from suppliers
Lack of standards and methods
Manual surveys and approximations

In practice, it is clear that perfect data is unrealistic at the beginning. The decisive factor is a step-by-step, prioritized approach that creates transparency and can be continuously improved.

CSRD as an organizational and system issue

A common mistake is to view CSRD solely as a reporting project. In fact, it concerns:

Existing IT and ERP systems
Quality and management systems
Roles, responsibilities and governance

A lot of CSRD-relevant information already exists – for example in purchasing, HR, compliance or energy management. The key is to bring this data together in a structured way instead of creating parallel isolated solutions.

Why early prioritization is crucial

Not all CSRD requirements can be implemented at the same time or are equally relevant. Companies that prioritize at an early stage,

reduce operational complexity
increase auditability
create realistic implementation timetables.

The aim is not to ignore requirements, but to structure them according to risk, impact and feasibility.

Conclusion: CSRD needs structure instead of perfection

CSRD in the omnibus process does not demand perfect reporting straight away, but rather comprehensible decisions, robust processes and a clear implementation approach. Companies that understand sustainability as part of their management logic and build it up systematically create a stable foundation, even in an evolving regulatory environment.

How we support you

The Experts Institute supports companies in classifying CSRD and ESRS requirements, setting priorities and developing an auditable, practical implementation. Get ahead and in touch with us: info@expertsinstitut.de

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4 weeks /by Nadjeschda Ilmberger

GMP, GXP, Sustainability

Continuous manufacturing: future trend in the pharmaceutical industry

The pharmaceutical industry is at a turning point. For decades, traditional batch processes characterized the production of pharmaceuticals. Although these have proven their worth, today they are often considered rigid, slow and resource-intensive. Continuous manufacturing opens up a new path: production no longer takes place in individual batches, but continuously and without interruption. This not only changes the speed of production, but also the quality, flexibility and sustainability of pharmaceutical processes.

What does continuous manufacturing mean?

In contrast to the traditional batch process, continuous manufacturing enables end-to-end production in a closed system. While intermediate storage and waiting times used to be unavoidable, continuous manufacturing allows for constant production and monitoring. As a result, companies benefit from shorter production times, consistent product quality and more efficient use of resources. At the same time, the technology makes it possible to react more flexibly to fluctuations in demand and avoid supply bottlenecks. Continuous manufacturing is therefore much more than a technological innovation; it represents a fundamental paradigm shift in the pharmaceutical industry.

Digitalization as a driver for process stability

The benefits of continuous manufacturing can only be exploited through consistent digital transformation. Modern sensor technology, Process Analytical Technology (PAT) and Advanced Process Control (APC) make it possible to monitor production processes in real time. This ensures process stability and deviations can be detected and corrected immediately. At the same time, end-to-end data acquisition ensures that quality information is seamlessly documented and integrated into regulatory systems. The result is not only stable and safe production, but also greater transparency with regard to GMP compliance.

Focus on regulatory requirements

The authorities have also recognized the potential. The FDA is considered a pioneer and has already granted the first approvals for continuous manufacturing processes. In Europe, the EMA is also taking a closer look at the topic. For companies, this means that investing in continuous manufacturing at an early stage not only makes it easier to obtain approval later on, but also puts them in a strategic position with regard to future inspections. Pilot projects are a valuable way of gaining experience and taking regulatory expectations into account from the outset.

Impact on supply chains and sustainability

An often underestimated aspect of continuous manufacturing is its contribution to sustainability. Reduced energy and material consumption results in less waste. At the same time, continuous production enables production “on demand”, which reduces stock levels and makes medicines available more quickly. Continuous manufacturing therefore offers a decisive advantage, particularly in crisis situations or in the event of supply bottlenecks. For the global supply chains of pharmaceutical companies, this means greater flexibility, shorter response times and overall greater security of supply.

Challenges on the road to implementation

Of course, the switch to continuous manufacturing is associated with hurdles. High initial investments, complex interfaces between IT, automation and quality management as well as the lack of qualified specialists present companies with major challenges. However, this is precisely why it is advisable to proceed step by step: Pilot projects offer the opportunity to minimize risks and build up expertise before the technology is introduced on a large scale. Those who consciously plan this path can actively shape the learning curve and anchor the change in the long term.

Conclusion: Experts Institut as a partner for your transformation

Continuous Manufacturing is not a trend, but the future of pharmaceutical production. Companies that take this step at an early stage not only secure advantages in terms of efficiency and quality, but also with regard to regulatory acceptance and market position.

The Experts Institute supports you with practical advice, tailored training and support for your digitalization and modernization projects. From the feasibility analysis and the development of an implementation plan through to regulatory-compliant implementation, we accompany you on your path to continuous production.

Contact us for customized solutions, together we will make your production future-proof. Get ahead and in touch with us – info@expertsinstitut.de

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24. September 2025/by Christoph Köth

Business Solutions, Sustainability

Combining sustainability and success: The new VSME standard for SMEs

Sustainability is becoming increasingly important in corporate management, particularly in the wake of new regulatory requirements at European level. For large companies that are already covered by the CSR Directive Implementation Act (CSR-RUG), reporting on sustainability issues is mandatory. However, small and medium-sized enterprises (SMEs) are also focusing on voluntary sustainability reporting. The EU’s new voluntary standard, the VSME (Voluntary Sustainability Reporting Standard for Micro, Small, and Medium Enterprises), now offers SMEs a clearly structured opportunity to get involved in sustainability reporting.

What is the VSME standard?

The VSME is a voluntary reporting standard developed specifically for micro, small and medium-sized enterprises that are not subject to the mandatory regulations of the Corporate Sustainability Reporting Directive (CSRD). The aim of the standard is to create a framework that enables these companies to report on their sustainability activities in a practicable manner. The VSME standard is intended to help provide sustainability information for lenders, investors and business partners and to make the company’s contribution to a sustainable economy visible.

Structure and modules of the VSME standard (sustainability)

The VSME standard has a modular structure and comprises various reporting requirements tailored to the size and structure of the company:

Basic module: Here, all reporting companies must provide basic information on areas such as energy consumption, greenhouse gas emissions, water consumption and governance. This module is the same for all companies, although certain information can be omitted if it does not apply to the company in question.
PAT module (Policies, Actions, Targets): This module is aimed at companies that have already developed and implemented strategies and targets in the area of sustainability. Reporting in this module is based on a materiality analysis that identifies the company’s key sustainability issues.
BP module (Business Partners): This module is intended for companies that want to pass on sustainability information to financial stakeholders and business partners. Here too, reporting is based on the materiality analysis.

Materiality analysis: the key to effective reporting

A central element of the VSME standard is the materiality analysis. This analysis helps companies to identify the issues that are material from both an environmental and social impact and a financial perspective. The focus here is on dual materiality – i.e. the consideration of both the company’s impact on the environment and the financial impact of sustainability aspects on the company.

The added value for SMEs

The VSME standard offers numerous advantages for small and medium-sized enterprises. Structured reporting in accordance with this standard enables SMEs to present their sustainability performance in a transparent and comprehensible manner. This creates trust among investors, lenders and business partners and can increase the company’s competitiveness. The VSME standard also provides valuable guidance for systematically integrating sustainability issues into the corporate strategy.

Sustainability: Conclusion

The VSME standard is an important step towards more comprehensive and transparent sustainability reporting, even for smaller companies. Thanks to its practical and flexible design, it offers SMEs the opportunity to actively participate in sustainable management and strengthen their position in the market. The Experts Institute recommends that companies familiarize themselves with the requirements of the VSME standard at an early stage and take advantage of the opportunities offered by voluntary sustainability reporting.

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4. September 2024/by Viola Cussmann