Iperion adopted the PRINCE 2 methodology as standard project management approach. Clear scoping, time lines, capacity requirements, mile stones, deliverables and reporting structure form the basis for successful projects. Our implementation process can be divided in different aspects.
When purchasing a QMS from Iperion, the application will be installed by our professional, experienced engineers. The installation can be performed on premise, at your own location. It is also possible to install the application off premise, on the GxP qualified platform in Iperions compliant datacenter.
As no two companies are exactly the same, there is no true off-the-shelf, one-size-fits-all solution. Configuring a system to meet a company’s unique requirements is one of the most important aspects of a system implementation.
At our customer workshops we meet with your company’s process owners and experts to agree on the best possible system configuration for you. We bring the best practice knowledge based on our years of experience in the field and you bring the insight into your company processes that only you can provide. These sessions will result in an agreed configuration which will be documented and formally approved. This vital document will serve as a base line for system change control.
These days, research, development and manufacturing are largely dependent on computerized systems. The guidelines and legal standards that govern the life sciences industry specifies that these systems need to be validated. However, validation is not only a regulatory requirement; it is your only way of ensuring that your systems operate the way that they are supposed to. To aid you in your effort to comply with government regulations and keep your IT-infrastructure adequately documented, we offer a start-to-finish solution for validating an information system according to GAMP5 (Good Automated Manufacturing Practice).
We use a risk based approach combined with tried and true example policies/templates to guide the validation process from planning to “go live”. Our approach is aimed at verifying that the system is fit for purpose. We make sure that all knowledge of how the system works is made explicit and documented and that policies and procedures are set up to maintain the system in a validated status.
Our trainers are respected authorities in compliant information technology and our training ensures an understanding and increased knowledge of our systems, solutions and services. Courses will be organized at our Training Center in Vlijmen or on-site at your location. We provide system specific training as well as GxP cloud computing training. Depending on your specific situation we are able to customize our training program to align with your company training requirements.
The training programs are as much as possible hands on, supported by the provisioning of relevant back-ground information. This allows the trainees to gain overall insight, understand how their tasks are supported by the system as well as being able to execute the different activities in it.
We have the tools and equipment to allow fast and reliable communication, logging of incidents, monitoring of activities, and problem resolution. We work in close connection with our system suppliers in case software issues cannot be resolved by Iperion.