Our Services

A suite of services to improve businesses processes to be more efficient and compliant.

REGULATORY COMPLIANCE

Our compliance service covers strategic view, tactic and operational view. Deep knowledge about formal requirements mixed with many years of experience enables the company to deliver high quality services. We are members of industry association (ISPE) and follow closely movements in legislation. E.g. Data integrity and the use of Cloud Computing. The services covers end-to-end thinking in terms of Business Process, supporting applications and IT Infrastructure.  Training is a natural part of our Compliance Services. We do not only give advice – we aslo execute,

  • Develop or improve quality systems
  • Internal/External audits
  • Develop or improve processes
  • Deliver Validation / Qualification of IT, clean room, business processes
  • Cloud Computing and outsourcing
  • Life Science: SE and EU Legislation, FDA 21CFR Part11
  • Best Practices: GxP, GAMP, ITIL, ISPE Infrastructure Qualification
LEAN

We can be part of your LEAN journey by inspire, train and coach. We are also working together with partners in special areas eg LEAN Leadership.

  • Introduction to LEAN
  • The LEAN Game (Administration)
  • LEAN Training (Tools)
  • LEAN for managers
  • Coaching
LOGISTICS

We have implementing ERP systems for a number of customers including for a medical device company. We have been an active part from the requirement phase through configuration and testing to implementation.

  • Implementing ERP (Enterprise Resource Mgmt System)
  • Improve Internal logistics
  • Improve Supplier logistics
  • Improve Inventory Management and KANBAN
IT PROCESSES

How IT needs to be maintained and govern can vary based on the size of the company. However, there are common principles  to be considered to deliver secure and stable IT services, where unplanned stops are prevented. IT has given a lot of attention from inspectors lately and maintaining Data Records and using cloud based services are few examples of focus areas. We can help you.

  • Process to support company needs
  • Full control of IT
  • ITIL based IT governance processes
  • Fulfill regulatory requirements
PROCESS DEVELOPMENT

The first step to develop or improve a process is to get it described. Simple tools can be used such as Value Stream Mapping or  the Astrakan model). Keep it simple is the leading phrase. Workshops can be used to get a common understanding and LEAN principles to find improvements.

  • Process to support business needs
  • Process to be described and mere efficient
  • Process to be compliant and maintained

 

THE WAY WE WORK
Though each project is unique, we have a established a 5 step process that ensures your project is completed on time
  • IDEA

    Defining Purpose and Scope for the project

  • PRE STUDIE

    As-Is status and areas for improvements are identified. In other cases General requirements for the product or processes are defined. Together with an Impact Analysis it defines the proposal for a project.

  • DESIGN

    The project makes a detailed plan and starts to design and define interfaces to other parts of the company.

  • DELIVER

    The project delivers according to project scope, the designs and communicating progress on a regular basis, typically on a One-Pager status report to steering group or other stakeholders.

  • GO-LIVE

    Hand-Over to Business (or customer) can be done after the project delivered all deliverables in scope. This is a pre defined hand-over to ensure knowledge transfer and a product/Service that will work throughout the life cycle.

ABOUT US
Visinge Consulting supports customers in regulated business with professional services.
CONTACT
FIND US
  • Husby Gränd 3, 184 44 Åkersberga, SWEDEN
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