We support you in two main areas:
Compliance & Validation
„Common sense is the talent to see things as they are and to do things the way they should be done.“ Calvin Ellis Stowe
Above all, compliance needs to be addressed with common sense and a sense of balance – as well as specialist expertise and knowledge about standards and regulations. Staying true to this mantra/value, we support you in:
- computerised system validation according to GAMP
- developing a validation strategy
- creation of validation documentation
- review of validation documentation, e.g. in the role of a project quality manager
- GxP compliant process design and implementation
- supplier assessments
- internal compliance checks
- awareness activities and training (CSV, GxP, Records Management, Good Documentation and Good Testing Practice)
We are honest and transparent partners to our customers, who have told us that our reliable and verifiable results have let to mutual trust.
We value and keep a constructive dialogue with your and your team, which leads to pragmatic and appropriate solutions. These, in turn, are the solutions that you and your teams will implement and embed, so that desired benefits can be realised. That your organisation is not only legally compliant but ultimately benefits from the compliance and validation solution is paramount to us.
We support you in realising these benefits by providing training, coaching or expert consultancy. We deliver bespoke solutions instead of ready-made concepts.
„In a knowledge society everyone is a volunteer.“ Peter Drucker
Welcome to the Knowledge Garden. Our definition of knowledge management: Knowledge management shapes a beneficial environment for productive knowledge work. With our full commitment and a good dose of pragmatism we support you in:
- developing and implementing a knowledge management strategy
- assessing the as-is state of KM (KM audit)
- implementing KM according to ISO 9001 and ISO 30401
- implementing KM tools
- Intellectual Capital Reporting
- Expert Debriefing
- identifying and transferring Lessons Learned
- creating awareness by employees and executives
- trainings and workshops on KM for novices and advanced
- review of your existing KM strategy
- establishing KM controlling for impact assessment
We aim at a transparent and honest partner-like relationship with our customers. Mutual trust is based on reliable and verifiable results on our part. There are no panaceas for your knowledge management or your processes. This is why we value a constructive dialogue with you and your employees. It is only from dialogue that emerge pragmatic and appropriate solutions, which are accepted by people and can unfold their full potential.
Your clear benefit is paramount to us. Thus, our concepts can actually be realized and we support you in their realization as trainer, coach or expert consultant.
Custom-fit solutions instead of ready-made concepts.
Our aspiration: custom-fit solutions instead of ready-made concepts.
Since 1996 I have grown my practical expertise on how to best support the development and establishment of sustainably successful knowledge management systems in various organisations – from big corporate groups to small and medium enterprises, in the private and in the public sector, at home and abroad. Through many different consulting projects I have developed clear concepts for the intelligent management of knowledge and information in organisations.
Moreover, I worked in numerous projects for pharmaceutical companies in the domain of computerised system validation as well as design and implementation of GxP compliant processes in IT, including training and change management. On the basis of my extensive pharmaceutical experience, I follow a risk-based approach, to do the necessary in the right way and with a reasonable portion of common sense.
On request, I will send you an up-to-date list of track records and project references. Please contact me.
Many of these hands-on experiences have found their way into my book “Knowledge Gardening” [Link zur Buchseite] and I am writing about them in specialist articles, lectures and talks, and not least, I have turned them into various video clips provided on my YouTube channel.
I am a member of the advisory board of the German Society of Knowledge Management (Gesellschaft für Wissensmanagement e.V.) and a lecturer at Baden-Wuerttemberg Cooperative State University, University Duisburg-Essen, Technical University Kaiserslautern, Bauhaus University Weimar, and Danube University Krems.
Gabriele Vollmar M.A.
In the spirit of crowd intelligence and agile management, I collaborate with competent and reliable partners. For my customers this flexible network organization offers the advantage of customised competences in a variable team – able to meet individual and concrete project need. Compared to traditional organizational structures, we do this with minimal effort and minimal administrative overhead.