BUSINESS SOLUTION
Good Automated Manufacturing Practice (GAMP) and GxP are safety and quality systems in the pharmaceutical and life sciences industry and within laboratories. GxP starts with Good and ends with Practice, with the name of the system in between. For organisations that work with Zenya and want to achieve Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP) or Good Documentation Practice (GDP), the set-up of our software must also be validated. The business solution Zenya Validation supports you in this.
Use Infoland’s expertise to support and accelerate your validation process
Get unburdened and focus on the other aspects of certification
Take a targeted approach to GxP, GAMP and other certifications where software validation is important
Organisations that want help validating the set-up of their Zenya software sometimes have no or too little time and capacity available for this themselves. Validation is therefore a comprehensive and time-consuming activity, especially if you are not fully versed in software set-up.
With our expertise, you save a lot of time and can count on high-quality documentation for validation. Our functional administrators know the software through and through and are able to quickly understand the set-up of your Zenya software. This allows us to quickly take the right steps to implement improvements and document configurations. This ensures an efficient validation process. You can also choose to let us support you with periodic validation, for example after Zenya software updates that may affect validations.
When purchasing the software, we help you with the User Requirements Specification by preparing a document with the user requirements specifications. We also ensure that comprehensive testing materials and information on testing from Zenya are available to your organisation on demand.
During the implementation phase, you will work with the consultant to establish the setup. After this, we can provide you with a checklist tailored to this setup to test the software and the setup. After this testing phase, we provide you with configuration specification documents, which describe in detail the configurations made.
With Zenya updates, the software may change in such a way that you need to retest. We can then help you with checklists specific to your Zenya configuration. Based on these, you can test the configuration in the test environment, so that validation is again in order after updating the production environment.
The Zenya Validation business solution was developed for customers who need to comply with GxP, GAMP or other certifications, where validation of the software setup is an important item. Often these are customers in the pharmaceutical and life sciences industry and laboratories.
Does this solution suit your organisation? During a conversation, we can tell you more about the possibilities. Please contact us.
When choosing this solution, it is good to know what is included.
This is what you can expect from the business solution “Zenya Validation”:
Are you interested in Zenya solutions and want to know more about one or more of them? If so, please let us know. We will be happy to discuss the possibilities for your organisation.