System Implementation & Validation
With a pragmatic approach we navigate regulatory complexities, ensuring your system functions reliably. From planning and gathering requirements to testing and training, we tailor solutions for compliance, safeguarding your critical data.
Activities
Requirements Gathering
Mitigating risks prior to implementing a system by evaluating impacted Business Processes, User Needs and System Functionalities.
Configuration
Meet requirements of users, regulators or applications with a solid system configuration that boosts efficiency and minimizes risks.
Documentation
Ticking off all required documentation for a system implementation such as URS, SOPs, WIs, Test Scripts and Validation Protocols.
Test Specification & Execution
Supporting in writing, reviewing and executing test scripts while being documented in a compliant way.
Training
Providing training support required for a successful system go-live through different training types and formats.
Watch now: RIMS Implementation Roadmap
This video covers a 9-step roadmap to implement a Regulatory Information Management System, from initiation to project closure, sharing tips and tricks for vendor selection, system design, implementation, validation, and training.
Requirements Gathering
Gathering requirements before implementing a new GxP information system is essential for alignment with Regulatory standards and meeting business needs. A thorough evaluation of Business Processes, User Needs, and System Functionalities helps you mitigate risks before they occur.
Excel in defining your User Stories, Requirements Specifications with 18 requirements categories from our download ‘Defining User Requirements – Focus on what really matters‘.
Configuration
System configuration determines how different elements interact with each other and establishing settings to optimize performance, security and functionality. This process is essential for ensuring that a system operates efficiently and meets the specific requirements of its users, regulators or applications.
Our specialists are seasoned eDMS, eLMS and eQMS system configurators reducing your risks of non-compliance and boosting efficiency. Get in touch to hear more about our approach to system configuration.
Documentation
A pragmatic approach lies at the heart of our system implementation projects. Defining the best way forward and getting started while checking off all required documentation. From User Requirements Specification (URS) to Functional Specifications, Test Scripts and Validation Protocols, Standard Operating Procedures (SOPs) and Work Instructions (WIs).
ION Pharma delivers the right documentation during implementation and gets you started with documents and templates to be used after implementation has been completed.
Test Specification & Execution
Any validated system has to undergo thorough operational, performance and user acceptance testing before go-live. This includes writing and reviewing of test scripts, execution of these scripts all while being documented in a compliant way.
Experienced testers are ready to get your tests started efficiently. Get in touch to hear how ION Pharma can support.
Training
A successful go-live of a system and its user acceptance go closely with the level of training of the end-users. These training types can vary between types as Role-based Training, Hands-on Practice or Hands-on Workshops while being presented in different formats. For example, Read and Understood, Frontal Teaching, Online or through Train the Trainer.
We can support in creating and preparing training materials such as Work Instructions (WI), creating presentations or organizing interactive sessions as well as acting as the trainers.
Contact us
We are here to help, whether you are looking for advice or additional information. Let’s get in touch.