Preparation Audit
Paper to Software
Begin your digital transformation with Novatek Europe and say hello to a paperless environment
The process of moving our day to day from paper to a software environment is challenging and sometimes even frightening for any Company. Even more so when this process is necessary to allow for compliance and meeting stringent regulations. Often the hardest step is the first one. Novatek Europe will help you navigate this process by offering you a detailed Preparation Audit.
We offer expert consultation in the following areas: Raw Materials, Stability, Finished Product, Environmental Monitoring, and Cleaning Validation
Consultancy Workload
- SOP, work instruction structure and assessment of impact
- Current validation and qualification approach
- GAP assessment on system implementation, validation approach (EU/EEA, US, industry standards)
- Current process evaluation, inputs and outputs currently
- Input and outputs for the LIMS system
- QC sample handling, IPC sample handling mapping, LIMS interface, sample processing requirements
- Method creation, maintenance, validation and interface with LIMS
- QC test result management: data generation, data management, current process and LIMS interface, data verification
- Interface with QC instruments, and other systems
- CoA issuing process
- Data integrity
- Hardware assessment assistance
- IT network assessment assistance
Deliverables
- Analysis of the Data collected
- A detailed report of recommendations
Novatek will help you every step of the way to make this process painless and allow you to start planning for the future today.
To arrange for an initial discussion
