Information security – a must for modern companies

In today’s digital world, information security is more than just a technical concern: it is a business-critical necessity. Companies must protect sensitive data and at the same time meet legal requirements. This article highlights the most important aspects of information security with a focus on the implementation of an ISMS according to ISO 27001 and the new EU NIS2 directive, which comes into force in 2024.

Why is information security important?

Information security ensures the confidentiality, integrity and availability of data and IT systems. It not only protects against cyber attacks, but also ensures the continuity of business processes. An effective information security management system (ISMS) helps companies to identify and minimize risks.

Implementation of an ISMS through ISO 27001

ISO 27001 is an internationally recognized standard that helps companies to develop and implement an ISMS. It offers a systematic approach to protecting information and minimizing risks.

Why is ISO 27001 important?

  • By complying with ISO 27001, companies can strengthen the trust of their customers and partners
  • Many industries require compliance with certain security standards, ISO 27001 helps to meet these requirements
  • The standard provides a clear framework for identifying and managing security risks

Steps for implementation

  1. A project team is set up to take responsibility for implementing the ISMS
  2. Clear roles and responsibilities are defined to ensure smooth implementation
  3. A delta audit and an inventory are carried out to identify vulnerabilities and the current security status
  4. All employees involved are sensitized and qualified through targeted training courses
  5. Departments receive weekly task packages that cover various chapters of ISO 27001
  6. A comprehensive, digitalized ISMS is created to ensure sustainable information security
  7. Internal auditors are trained to carry out regular audits in the company
  8. Regular internal audits ensure that all measures are properly complied with
  9. A gap analysis is used to identify weaknesses, which are then remedied with a concrete action plan
  10. The action plan is implemented by implementing the planned measures in a targeted manner
  11. The certification process is continuously monitored until successful completion of ISO 27001 certification

NIS2 and the connection to ISO 27001

The NIS2 Directive, which comes into force in October 2024, tightens information security requirements, especially for operators of critical infrastructure (KRITIS), and affects around 21,600 new companies in Europe. The aim of the directive is to strengthen protection against cyberattacks and resilience.

ISO 27001 and NIS2 both pursue the goal of information security, but differ in scope. While ISO 27001 provides a flexible framework for implementing an ISMS, NIS2 adds additional requirements specifically aimed at KRITIS operators and critical facilities. Companies that are ISO 27001 compliant have already met many of the NIS2 requirements.

NIS2 introduces the following obligations for companies:

  • Companies need to further enhance their security standards and conduct regular audits to ensure both cyber security and physical resilience
  • Security incidents must be reported within 24 hours as there are stricter reporting requirements
  • Violations may result in penalties in the form of fines of up to 10 million euros or 2% of global turnover

Conclusion: Why information security is essential for companies

The importance of information security in the modern business world cannot be overemphasized. With increasing connectivity and the steady rise of cyber threats, it is becoming imperative for companies to develop robust security strategies and comply with regulatory requirements such as the NIS2 directive. By implementing an effective information security management system in accordance with ISO 27001, companies can not only minimize their risk, but also strengthen the trust of their customers and partners. Given the new challenges that come with NIS2, it is crucial that companies act proactively to adapt to the increased information security requirements and avoid potential sanctions.

How we as Experts Institut can help

As Experts Institut, we offer comprehensive consulting services for the implementation and optimization of ISMS in accordance with ISO 27001. We also support companies in implementing the new requirements of the NIS2 directive. Our focus is on supporting customers in complying with IT compliance requirements and strengthening their information security.

Are you considering optimizing the security measures in your company? Get ahead and in touch with us – info@expertsinstitut.de

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ISO 9001 certification: Step by step to a successful QMS

ISO 9001 certification is an internationally recognized standard in quality management. It stands for trust, efficiency and reliability – qualities that customers and business partners value. However, the certification process can seem challenging. In this guide, you will learn how to successfully implement certification and how we can support you step by step.

Why ISO 9001 certification?

ISO 9001 certification offers many advantages: more efficient processes, better risk management and greater trust from customers and partners. It can also open up new business opportunities, as many tenders and contracts require ISO certification.

ISO 9001

1. initial consultation and analysis: the start

The first step towards ISO 9001 certification is a comprehensive analysis of your existing structures and processes. This will determine how well your quality management system (QMS) already meets the requirements of the standard and where improvements are needed.

Why is this important? Many companies already unconsciously fulfill parts of the ISO 9001 standards. A professional analysis uncovers these strengths and identifies specific weaknesses in order to make the process efficient and time-saving.

2. planning the implementation: tailored to your requirements

Following the analysis, a customized implementation plan is drawn up that defines all the steps required for full compliance with ISO 9001 standards.

What makes this step so important? Thoughtful planning ensures that the standard requirements are implemented without disrupting your day-to-day operations. This maximizes the benefits of certification and minimizes disruption.

3. implementation of the quality management system (QMS)

Now it is a matter of either implementing the QMS from scratch or optimizing existing processes. This ensures that all requirements of the ISO 9001 standard are met.

Why is this important? An optimized QMS not only improves the quality of your products and services, but also increases efficiency. Clear processes, reduced errors and motivated employees contribute to successful certification.

4. internal audits and training: Preparation is everything

Internal audits and the training of your employees are essential components before the official certification audit begins. They identify weak points and ensure that the QMS is implemented correctly. At the same time, employees are prepared for the new processes.

Why this step? Training ensures that employees understand the new processes and use the QMS efficiently. The internal audits ensure that your company is ready for official certification.

5th certification audit: The decisive step

During the certification audit, an external auditor checks whether your company meets the ISO 9001 requirements. This is the last step before receiving the certificate.

Our support: We accompany you through the entire audit process and are on hand to answer any questions or challenges you may have. Our aim is to make the audit as smooth as possible and ensure successful certification.

6. receipt of the certificate: Your seal of quality

After the successful audit, you will receive the ISO 9001 certificate, which is valid for three years and confirms that your company meets the highest quality standards.

What comes next? Regular internal audits and continuous improvements are crucial in order to maintain certification in the long term and to be successful in the recertification process.

Conclusion: Your partner for successful ISO 9001 certification

ISO 9001 certification requires careful planning and specialist knowledge. With our advice at your side, the process will be smooth and efficient. Contact us to find out more about our customized consulting services and make your certification a success. Get ahead and in touch with us – info@expertsinstitut.de



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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.

Sustainability

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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Quality Management Maturity: The Importance of Good English Writing Practices (GEWP)

English is common for most who work in a GxP-regulated industry. Though most would consider themselves firm English speakers, the truth of the matter is: most will never go beyond some standard vocabulary, and most have only little understanding of English grammar and writing style. After the Brexit, in Europe very few are English native speakers. One could likely make a case for that even English EU GxP Guidance and Drug Regulation documents suffer from this issue.

No, English is in fact not easy – good English is just not!

In company GxP documents and reports the English text often suffers from features of other languages which are unknowingly imposed on it because authors and reviewers are not native speakers.

Consequences of Poor Language Quality

Clarity and quality suffer, content is misrepresented, reports are harder to read later on, procedures are misinterpreted due to undetected ambiguity, even wrong conclusions can be the consequence of using substandard “EUnglish” instead of actual English. And when a native English speaking authority comes in for inspection (USFDA, TGA, MHRA) all of a sudden QA wonders why the authorities have such trouble seeing through the local QMS and GxP-system and find what they read rather irksome (if You need to look up “irksome” then I totally got You!). “And here we thought all is fine…”.

Tailored Training by Experts Institute

Experts Institut offers a customized and Taylor-made applicational training on “Technical Editing of GxP Documents: The Relevance of Quality and Style”. This training is relevant for really all levels of GMP-/GxP-regulated organizations. The training provides theoretical elements of English language features and how they can interfere with other languages in GxP documents and reports. Important elements in English writing style are presented as well. Application of the theoretical part is then trained in inductive workshop sections to gain immediate hands-on understanding of how all this plays out in real GxP life.

Basic quality systems can make good use of this, just as well established ones can. It is a great contribution to the foundation of Pharmaceutical Quality Management Maturity.

This training is one of many reasons why Experts Institut is so unique in its work portfolio: We go beyond GMP/GxP-only – We see the big picture – We see the whole. For your benefit.

Feel free to contact us and make an appointment to talk about how we can customize this expertise to Your need. Get ahead and in touch with us – info@expertsinstitut.de

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Crossing Cultures in Audits and Inspections

Today the world, with its regulated industry, is strongly globalized. The cultural diversity of a company’s staff can be huge, reflecting different cultures from around the world. This is one reason why many would assume that the entire world can be talked to, related to, and understood quite readily. It is part of everyday work for many after all-or so we think.

In the area of audits and inspections, crossing cultures happens all the time. Different cultures bring different perspectives, which can influence how audits are perceived and conducted. Where supply chains are globalized, trans-national and trans-continental audits and inspections are mandatory and pretty much normal in many company and regulatory settings. Understanding the nuances of each culture involved is essential for effective communication and successful outcomes.

True Multiculturalism and Cultural Limits

This poses a problem though: we learn to communicate, read, and perceive in our birth culture. And even if a society is highly diverse, we are still product of a cultural framework that is discrete-in other words, that has boundaries. It is simply impossible for one person to really become multicultural-ourlifespan is just not large enough. You may be the child of a double or third culture set of parents, but true multiculturalism in a single individual is virtually impossible.

So as we are controlled by our birth culture, we do not learn how to properly navigate in foreign cultural contexts (and globalization does not do away with this at all). We may think we know what is going on around us when we engage people from other host cultures, but we really do not. Even in a seasoned friendship with someone from another country, there will still be a vast degree of ignorance in understanding the other person. We believe we know and understand. But we miss most of it in reality. We continue to filter everything we experience, see, hear and judge through what we believe is normal, and our frame of reference is our birth culture. And we cannot stop doing it because we are not even aware of it.

The Impact of Culture on Audits and Inspections

And now it gets interesting: This problem includes audit and inspection situations!
Good auditing is more than knowing compliance requirements, audit methodology, and a work experience of 100+ or even 1000+ audits.

Culture is so powerful that it controls everything we think, say and do. And what we expect of others. In an audit situation (also in GMP inspections), this routinely produces misunderstandings. And many of them are never corrected, simply because neither the auditor nor the auditee is aware of them.

From document reviews, an auditor may conclude that a company is falsifying records, when the truth is though that what the auditor saw has nothing to do with cheating at all.

An auditor may think the auditee is trying to avoid saying the truth about a given audit question or subject, but there is no intent of this in the conversation at all. But the auditor is blind to this.

As a result of examples like these, auditors will put their impressions into the report, in a coded form of course, but it will color all parts of the report and the perception of GMP deficiencies-even the judgment on severeness.

If an auditor is not aware of what is missed and where the personal perception of things is going astray, then such an auditor must improve. The objectiveness of the report will suffer, and the picture that is brought home is greatly inaccurate. We do a disservice to the auditee and to our own sending unit. And frankly, to ourselves…

This plays out even more drastically in audits of suppliers or service providers where no GMP or GxP quality system is available. Such cultural ignorance can make or break the business relationship altogether.

How can you improve?

  • Stop thinking that cultural differences are easy to figure out. You cannot guess them. You need extra training for this.
  • Understand that cultural differences have little to do with differing food preferences or how a business card must be presented.
  • Respect that standards-even GMP-can be lived effectively in different ways.
  • Open to the truth that you do not know everything best.

Read our full blog: https://experts-institut.de/newsroom/

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Crossing Cultures in Audits and Inspections

Today the world, with its regulated industry, is strongly globalized. The cultural diversity of a company’s staff can be huge. This is one reason why many would assume that the entire world can be talked to, related to and understood quite readily. It is part of everyday work for many after all—or so we think.

In the area of audits and inspections, crossing cultures happens all the time. Where supply chains are globalized, trans-national and trans-continental audits and inspections are mandatory and pretty much normal in many company and regulatory settings.

This poses a problem though: we learn to communicate, read, and perceive in our birth culture. And even if a society is highly diverse, we are still product of a cultural framework that is discrete—in other words, that has boundaries. It is simply impossible for one person to really become multicultural—our lifespan is just not large enough. You may be the child of a double or third culture set of parents, but true multiculturalism in a single individual is virtually impossible.

So as we are controlled by our birth culture, we do not learn how to properly navigate in foreign cultural contexts (and globalization does not do away with this at all). We may think we know what is going on around us when we engage people from other host cultures, but we really do not. Even in a seasoned friendship with someone from another country, there will still be a vast degree of ignorance in understanding the other person. We believe we know and understand. But we miss most of it in reality. We continue to filter everything we experience, see, hear and judge through what we believe is normal, and our frame of reference is our birth culture. And we cannot stop doing it because we are not even aware of it.

And now it gets interesting: This problem includes audit and inspection situations!

Good auditing is more than knowing compliance requirements, audit methodology, and a work experience of 100+ or even 1000+ audits.

Culture is so powerful that it controls everything we think, say and do. And what we expect of others. In an audit situation (also in GMP inspections), this routinely produces misunderstandings. And many of them are never corrected, simply because neither the auditor nor the auditee is aware of them.

From document reviews, an auditor may conclude that a company is falsifying records, when the truth is though that what the auditor saw has nothing to do with cheating at all.

An auditor may think the auditee is trying to avoid saying the truth about a given audit question or subject, but there is no intent of this in the conversation at all. But the auditor is blind to this.

As a result of examples like these, auditors will put their impressions into the report, in a coded form of course, but it will color all parts of the report and the perception of GMP deficiencies—even the judgment on severeness.

If an auditor is not aware of what is missed and where the personal perception of things is going astray, then such an auditor must improve. The objectiveness of the report will suffer, and the picture that is brought home is greatly inaccurate. We do a disservice to the auditee and to our own sending unit. And frankly, to ourselves…

This plays out even more drastically in audits of suppliers or service providers where no GMP or GxP quality system is available. Such cultural ignorance can make or break the business relationship altogether.

How can You improve?

– Stop thinking that cultural differences are easy to figure out. You cannot guess them. You need extra training for this.

– Understand that cultural differences have little to do with differing food preferences or how a business card must be presented.

– Respect that standards—even GMP—can be lived effectively in different ways.

– Open to the truth that You do not know everything best.

Want to know more? Ask for cross-cultural factor training for auditors and inspectors @ExpertsInstitut.

We can help You. And after this You will never be the same. You will be a better auditor. You may—in fact—be a better You. Yes – really.

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Retaxation – a lucrative instrument for health insurance companies

-Blog post on the subject of retaxation

Retaxations in pharmacies mean that the health insurance companies reclaim money that they have previously paid to pharmacies for the dispensing of medicines. This usually happens up to 15 months after the drug has been dispensed. This is particularly lucrative for health insurance companies, for example in the case of pharmacies that manufacture cytostatics. Cytostatic drugs are chemotherapy drugs that are used to treat cancer. Pharmacies produce these medicines in special laboratories according to the doctor’s instructions and in compliance with strict regulations. This production is always adapted to the individual patient.

With regard to the retaxation of cytostatic drugs, this means that health insurance funds check whether the dispensing and billing of these drugs by pharmacies has been carried out properly and whether all regulations have been complied with. If this is not the case, the health insurance company can demand money back and often uses this simply as a prophylactic measure to reduce the funds. In most cases, this is due to formal errors in the prescription (e.g. pink prescription issued by the doctor) or the billing of wastage (remaining quantities of the medicine required for production).

Retaxations can be very costly and economically ruinous for pharmacies and are often the subject of controversy and discussion between pharmacies and health insurance companies. However, pharmacies often lack the staff, time and expertise to process the mountain of retaxations and to draw up appeals with all the supporting documents in good time.

Retaxation

Strategies for avoiding retaxations

  1. Careful documentation: Precise and complete documentation of all processes, from prescribing to dispensing the medication, can help to avoid errors and maintain an overview.
  2. Ongoing training: Regular training of pharmacy staff on current regulations and billing practices can help eliminate common sources of error.
  3. Proactive communication: A close exchange with doctors and health insurance companies can prevent misunderstandings and clarify problems at an early stage.

This is where we, the Experts Institut, come in with our special retaxation service. Since 2008, we have been supporting pharmacies in taking professional and effective action against unjustified retaxations by health insurance companies. With our expertise and experience, we offer tailor-made solutions that relieve pharmacies of staff and help to minimize economic losses.

Please contact us for further information: info@expertsinstitut.de

Get ahead and in touch with us

Your Experts Institute Team

#pharmacies #retaxation #healthcare #drugs #pharmacy #health insurance #cytostatics #dispensing #billing #pharmaceutical consulting #pharmacy management #healthcare policy #pharmacy practice #drug manufacturing #PharmacistLife

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Computerized systems (CS)

CS are becoming increasingly important, especially in the pharmaceutical industry, in order to meet the increasing demands on production. At the same time, their use must not compromise patient safety.

This brings with it increasing challenges in the scope of validation and qualification of the system: Proof that CS function properly and do not pose an increased risk to patients can only be provided by taking a holistic view of the system. A master plan is therefore a useful document for defining the scope of the project.

Complexity of the scope of validation

The initial classification of the CS into a software category according to GAMP 5 provides guidance on the complexity of the scope of validation:

  1. Operating systems
  1. N/A
  1. Non-configurable software (standard software)
  1. Configurable software
  1. Individual customer software

A risk assessment is now used to check the criticality of the CS with regard to GxP relevance, i.e. the extent to which there is an impact on patient safety. A detailed identification and analysis of risks and the definition of suitable control measures to minimize or completely exclude these risks is essential. A continuous review is also essential for a complete audit.

In addition to determining areas of application, exact specifications and their influence on patient safety, individually planned tests with suitable acceptance criteria are also included in the CS review.

The validation of the process then goes hand in hand with the qualification of the process environment, divided into the phases of design, installation, function and performance testing. This allows individual specifications to be checked and verified step by step.

Only once qualification and validation have been successfully completed and proof of suitability for the intended process has been provided can the CS be used without any increased risk to patient safety.

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Artificial intelligence (AI) in consulting

How artificial intelligence is revolutionizing management consulting: Insights into a future where consultants and AI, go hand in hand

AI until 2030

In the rapidly evolving business world, companies face the challenge of keeping up with the latest technologies in order to remain competitive. Artificial intelligence (AI) is playing an increasingly important role in this transformation. In this context, the question of whether AI can replace the traditional management consultant is becoming increasingly important. Research, such as McKinsey & Company’s study, “Generative AI and the Future of Work in America,” predicts that by 2030, generative AI will automate tasks that currently account for up to 30% of labor hours in the U.S. economy. However, this automation will expand the way we work in specialized areas, not replace it.

Deloitte’s report “State of Generative AI in the Enterprise”

The question is whether the growing interest in artificial intelligence will win the race or whether fears and regulatory hurdles, particularly in the area of compliance, will gain the upper hand. Do the potentials of the technology outweigh the reservations, or are the latter blocking broad acceptance? Deloitte’s report “State of Generative AI in the Enterprise” shows a clear trend. Executives are enthusiastic about the possibilities of generative AI, with 62% rating generative AI as exciting. Nevertheless, there is a certain degree of uncertainty (30%). A majority (79%) expect generative AI to bring about significant transformations in their organizations and industries in the next three years.

Data protection and compliance

While concerns regarding data protection and compliance, for example, are certainly justified in the discussion about artificial intelligence, this debate leads to a significant insight: the role of the management consultant is not diminished by the integration of AI, but rather significantly expanded. By incorporating AI into their services, consultants can provide more data-driven, accurate and efficient solutions. This symbiosis of human expertise and AI capabilities promotes deeper analysis and a refined understanding of complex challenges, which ultimately increases the quality of advice and offers added value for the customer.

Commerzbank provides an innovative example of the application of AI in customer advice with the introduction of an AI-based banking avatar that combines generative AI and avatar technology to improve the customer experience. This underlines the versatility of AI in supporting and improving customer interactions and experiences.

Integration of AI

The integration of AI into management consulting (management consulting at EI) therefore not only enables more efficient data analysis and processing, but also promotes innovation and strategic development. Management consultants who use AI can concentrate on complex analysis and strategy tasks and thus create greater added value for their clients. This development indicates that the AI-savvy consultant will replace the traditional consultant without the use of AI in the digitally transformed business world. Integrating AI into consulting services is not just a possibility, but a necessity to be successful in the modern business world.

Artificial intelligence

Bibliography:

Deloitte. (2024). State of Generative AI in the Enterprise. [Bericht].

McKinsey Global Institute. (2023). Generative AI and the Future of Work in America. [Studie].

Commerzbank Aktiengesellschaft. (2023). Commerzbank plans banking avatar based on artificial intelligence. [Pressemitteilung]. Frankfurt am Main: Commerzbank Aktiengesellschaft.

Another article on the topic of AI / artificial intelligence: https://experts-institut.de/zukunft-gestalten-ki-als-schluessel-fuer-fortschrittliche-unternehmensfuehrung/

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Supplier qualification for pharmaceutical manufacturers

Field report by an EI consultant from a supplier qualification project for pharmaceutical manufacturers

In the period from 2019 to 2022, I was involved in a project for the supplier qualification of drug manufacturers and active ingredient manufacturers at a pharmaceutical company and generics manufacturer. The project team, consisting of up to four colleagues, was entrusted with various tasks and focal points to ensure smooth implementation.

Project overview and responsibilities

Before I took over the management of this project, my colleagues had already developed a checklist for the review of audit and inspection reports. As project coordinator, my main responsibility was to manage, coordinate and plan the activities. My tasks included direct customer contact and the exchange of information as well as requesting and evaluating audit reports for supplier qualification. I was also responsible for the creation and versioning of technical agreements, supplier monitoring and internal coordination with the specialist departments.

Inspection reports and quality assurance in supplier qualification

One of my main tasks was to check and evaluate the inspection reports (audit reports) for content, accuracy and completeness in accordance with the applicable GMP guidelines for the products and to document this using internal guidelines (SOPs) and checklists (audit report review).

Challenges

The challenges in this project were manifold. A tight schedule due to upcoming production & product releases required the tasks to be completed on time. In addition, global customer contact required effective communication and coordination across European borders. Another challenge was to work through the previous year’s backlog while maintaining ongoing business, particularly due to staff shortages and changes in the team. After completion of the project at the customer’s site, it was important to transfer the newly acquired knowledge and processes to the resident and newly hired staff and to ensure that the quality assurance processes & measures are continuously implemented and adhered to.

Successes and results of supplier qualification

Despite the challenges, the long-term collaboration within the team was very successful and our structured approach enabled us to fully meet the client’s requirements. Our work contributed significantly to the quality assurance of the company’s medicines and ensured that suppliers met the required quality standards.

Contact and support for supplier qualification

Are you also looking for support in supplier qualification or quality management? Our experienced team is ready to make your project a success. Contact us for a customized solution that is precisely tailored to your needs. Get ahead and in touch with us – info@expertsinstitut.de

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