Agriculture Chemical Food Consulting
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Volker Roeder
Volker Roeder

Quality and Compliance in medium‐sized agricultural, chemical and food companies

Intelligent solutions – at the highest level.

Lean Quality & Compliance, Agile Methods, GxP in the Cloud – for over 18 years, ARCONDIS has been advising medium‐sized agricultural, chemical and food companies (SMEs) when it comes to compliance and quality issues and has been supporting them in the development of intelligent solutions at the highest level.

In the process, our experienced Team of compliance experts not only provide their consulting expertise from over 550 Projects, but they also tailor all services exactly to your specific needs.

The result:

High quality, lean and therefore cost‐effective business processes that meet all regulatory requirements in accordance with best practices.

Rely on our expertise! Get in touch with us at one of our Locations.

Our Services

Managing projects competently and intelligently is our passion.
Our project leaders combine deep compliance expertise with high‐class project and change management. This allows us to create intelligent success through processes and solutions that are quickly adapted by the organization and that efficiently guarantee the fulfillment of the legal framework requirements.

Your benefits:

  • Implementation of official requirements through the perfect mix of project management and compliance expertise, while adhering to deadlines and ensuring it will pass inspection
  • Increased quality and efficiency through holistic requirement management from covering legal provisions to business fit for the specialist departments
  • Higher acceptance of new processes and rules through proactive change management

Project Management Frameworks

Project Quality Management

Program & Project Management

Get the mills grinding faster! Our experienced PMO teams will become the control center and early warning system for your project and facilitate your project's day-to-day business.

Our experienced consultants prepare you optimally for audits. In doing so, you receive all services from one source: from the initial analysis to planning and implementing measures to the support of the audit itself. We also advise you on the targeted follow‐up work and rectification of possible findings. Use our excellent service as preparation for official inspections and third‐party audits, including mock audits if desired!

Your benefits

  • Need‐based collection of status quos and possible gaps through tailored audit checklists, each according to the regulatory scope
  • Lean processes by prioritizing measures according to criticalness and urgency
  • Efficient and fast: audit and CAPA management from one source
  • Pass audits with confidence and sustainably establish audit readiness

Audit Preparation Service

Mock Audits

Audit Response Actions

CAPA Management

With more than 300 successful validations in 14 years, we offer compliance made to order, without unnecessary padding – from the framework to concrete validation and from laboratory system to ERP to cloud‐based CRM.

Your benefits

  • High audit security with overhead‐optimized implementation through our experienced validation experts
  • Compliance over the entire life cycle of the application due to reusable, simply expandable documentation
  • Quicker time to market through lean, risk‐based validation

CSV Frameworks

Validated Clouds

Validation of Life Sciences specific Business Solutions

Validation of Enterprise Solutions (ERP, Excel…)

CSV Trainings

In more than 150 qualification projects, we have been able to prove: We create intelligent solutions, which, in addition to fulfilling official requirements, increase the value contribution to the infrastructure through stable processes and reliable services in a cost‐effective way!

Your benefits

  • High audit security with overhead‐optimized implementation through our experienced qualification experts
  • Avoiding redundant work by applying onboarding with the help of an integrated qualification strategy
  • Cost‐reduced operation while simultaneously guaranteeing compliance through controlled IT processes according to best practices

With an effective IT QMS you can accomplish two goals at the same time: You can enhance the contribution made by IT through stable and reliable services while demonstrably meeting the requirements of regulated IT. A QMS is effective – both internally and externally. We’ll show you how!

Your benefits

  • Inspection readiness while simultaneously increasing your performance by using lean, controlled IT processes according to best practices
  • Proof and monitoring of performance and conformity with regulations related to IT in the company and to external authorities
  • Faster and higher acceptance of the QMS among employees due to proactive organizational change management according to Prosci and PCI

IT Quality Management Frameworks

IT QMS Compliance Checks & Optimization

QMS Tool Evaluation & Implementation

Qualifying and validating devices and systems is an obligatory task in regulated industries. Above all, this task must be audit‐secure and efficient. In the cooperation with our tried and proven partners, we offer this perfect mix: excellent conception, guidance and monitoring through our compliance project leader with reliable and sophisticated test implementation through our partners.

Your benefits

  • High audit security with cost‐optimized implementation through our team’s optimal combination of expertise
  • Overhead‐reduced, risk‐based procedure, proven by hundreds of applications
  • Minimal management need on the client side due to our experienced project leaders and proactive status reporting
  • Quantifiable investment with guaranteed returns, both as regards quantity and quality

Quality Management in regulated industries is more than reaching GxP compliance. A sustainable Quality System (QS) is the basis of your business’s success. With an effective QS, you will increase the value contribution of the quality assurance through stable and reliable processes and fulfill regulatory requirements demonstrably in the process.

Your benefits

  • Market‐ and need‐based QS tailored to your company with appropriately high internal and external acceptance
  • Fulfillment of applicable regulatory requirements while simultaneously avoiding over‐interpretation
  • Securing your business success through targeted and cost‐conscious quality management processes

Compliance Checks & Optimization of Quality Management Systems

Introduction & Optimization of Quality Processes

Benefit from tailor-made in-house training sessions based on your compliance framework. From awareness of compliance issues to process-specific expert training!

Enormous pricing pressure, increasing commodity prices and intensified regulatory requirements demand of manufacturers in regulated industries that they make a new maturity class of processes with regard to efficiency, costs and compliance. We have been successfully supporting our medical technology customers in the optimization of their process landscape in the GxP environment and beyond for 15 years.

Your benefits

  • Ongoing and lean business process framework from governance to SOPs, certification‐ready
  • Increasing agility and avoidance of faults through the transparency of the business and quality processes
  • Best practices process modeling and process documentation, independent of the software used (Adonis, ARIS, Visio and many more)

Business Process Management Frameworks

Business Process Analysis & Optimization

Process Modeling & Documentation

Companies in regulated industries have the double burden of auditing not only their own products, but also purchased services and suppliers. Our certified and experienced auditors relieve your internal teams and take over the overall auditing responsibility in a cost‐effective manner, from planning to implementation to the audit report.

Your benefits

  • Professional planning and implementation of internal and external audits for supporting and relieving internal auditors
  • Neutral assessment through independent experts
  • Short‐term availability of Lead & Co auditors
  • Certified auditors with many years of practical experience

Supplier Audits

Mock Audits

Internal inspections

Very reliable and expertise in various industries and technologies. Can cope with complexity.
Business Solution Manager
Medical Device Company
Our ARCONDIS consultant constantly delivers timely and high quality output. She demonstrates very good communication with the scientists as well as with the informatics colleagues and is fully recognized in the role.
Leader Discovery Workflow
Pharmaceutical Company
I would recommend the service from ARCONDIS because it is straight forward and performed with high quality. Also I do appreciate the open and honest environment working together with ARCONDIS.
Global Project Manager
Medical Device Company
​Very experienced, knowledgeable senior consultants!
Lead Continuous Improvement
Food Company
ARCONDIS has been a tremendous addition to our programme!
Site IT Head
Global Swiss pharmaceutical corporation
Marina continues to deliver high value and in ambigous areas! She has continued to move things to the next level and while it will be hard to the project team to loose her I am happy she will be joining another one of our projects.
Trial Master File Manager
Global Swiss pharmaceutical corporation
The best Business Analyst with whom I’ve ever had the privilege to work.
Head of Mobile Services
Pharmaceutical Company
The employees of ARCONDIS are reliable, straightforward and do a good job.
Team Lead Quality Control
Medical Device Company
Christian is a very senior project manager who covers all areas of management and leadership within project and program level, for any change management initiative on any level. He can be recommended for any type of engagement of similar or even bigger scope on any level within IT, but even outside IT in general management
Global Head End User Experience
International Pharmaceutical Company
I would absolutely recommend both Mark and ARCONDIS. Mark’s thought-leadership has been invaluable, not just to his own project but to helping improve the program.
Program Manager for Global User Experience Program
Global pharmaceutcal corporation
Incomparable response times and commitment! Last-minute requests are delivered quickly, with good quality. The "problem" is examined from different angles, opening up new perspectives. The colleagues at ARCONDIS are ready to support customers in all their concerns and go the extra mile.
Global Business Services
Global Swiss speciality chemicals corporation
I am really satisfied with the people at ARCONDIS and their performance!
Business Solution Manager
Global Swiss pharmaceutical corporation
ARCONDIS provided us with an experienced project manager who was able to quickly and efficiently replace the previous project manager. He also successfully completed two, not necessarily simple IDMP experiments.
Business Solution Manager
Pharmaceutical Company
Christian gets 11 of 10 points. I just can dump work on him and it is getting done! 100% reliable, very good in service management, project management even better.
Business Solution Manager
Pharmaceutical Company
Stefan has been an excellent project manager. I liked the way he identified one of the more challenging characters and then found a way to work well together. A very well run project that I enjoyed participating in.
Global R&D Portfolio Manager
Agriculture Company
​Lars is a motivated, skilled, organized, goal oriented, driven, pro-active and friendly person to work with. His engagement in this project was crucial for the achieved success.
Head E-Learning
Medical Device Company
Joachim is a critical team member. He exceeded impossible expectations.
International Patient Innovation Director
Global Swiss pharmaceutical corporation
ARCONDIS is my prefererred supplier which I will approach whenever possible/needed. Also, I will recommend ARCONDIS at any time.
Head of Medical and Scientifc Systems
Global Swiss medical device manufacturer
Mark is a real good project manager and is extremely capable. If you let Mark fill in the space, he is doing it, never hesitating to drive and step to the plate. Extremely valuable. Mark is going the extra mile with one idea in mind: make sure the project progresses!
Global Head of Digital Services Delivery
Pharmaceutical Company
High level of self-management and the "engine" of our projects!
Head of Quality Assurance
Chemical Company
I am very pleased with the overall quality of the personal that has been seconded to us from ARCONDIS. High quality, well qualified, reliable and professional when dealing with customers.
Domain Head R&D IT
Agriculture Company
Boris has been a strong and very talented team member. His performance does continue to exceed my expectations. His ability to remain level headed and artfully navigate a highly politically charged project has been outstanding.
Domain Head R&D IT
Medical Device Company
Overall good collaboration with the ARCONDIS team. Very good understanding of customers and projects, even with complicated and difficult topics. The ARCONDIS team represented true added value for the project!
IT Program Manager
Global Swiss transportation and logistics service provider
Karin has done a great job of making sure that the plan is complete and staying on top of me to ensure that tasks are complete. Her character and personality, as well as her professionalism have been a credit to this project and are one of the key factors in how well it is running.
Technology Evaluation Lead
Agriculture Company
I would absolutely recommend both Mark and ARCONDIS. Mark’s thought-leadership has been invaluable, not just to his own project but to helping improve the program.
Program Manager for Global User Experience Program
Global pharmaceutical corporation
I was impressed with the services that ARCONDIS have provided. It takes strength of character to handle constant changes and Jan has demonstrated he has the experience and also the professionalism to still thrive under pressure. He is fully integrated into the team and I look forward to continuing the engagement with ARCONDIS.
Data Governance
Global Swiss pharmaceutical corporation
I was impressed by the work quality. Having less resources and a new team of developers, your consultant wisely prioritized the objectives and guided the team toward delivering quality results. Honestly, I learnt a lot of, her in many aspects.
Lead Scientist
Pharmaceutical Company
Always available when needed and always going the extra mile to ensure success of the team.
Project Manager
Pharmaceutical Company
Dealings with different groups were done really professionally to push forward to goals. Marina is easy to work with and enjoys being part of the team, positive feedback from all of team. To me she's a rising star.
Project Manager
Pharmaceutical Company
Jan is unquestionably one of our most valued team members. Extremely competent, always polite and professional while remaining personable and eminently likable. Has a great no-nonsense approach: meetings with Jan are never unnecessary and never over-run. If we could clone Jan, we would!
Mobile and Wearable Sensor Lead
Global Swiss pharmaceutical corporation

We realize solutions. We ensure benefits that can be experienced with our sophisticated concepts and intelligent implementation. We have proven this time and time again in the past - for example with the following projects from your sector: