To avoid potential non-compliance situations, small or mid-sized life sciences and biotech companies need to define their IT processes.
Without a standardised approach for IT development and maintenance, this can be a complex task. And it can result in insufficient IT performance and stability.
To address this issue, NNIT has developed a concept called compliance-in-a-box. This approach is tailored to meet the needs of mid-sized life sciences and biotech companies that want to establish a compliant IT environment in a cost-effective manner.
Compliance-in-a-box ensures:
- Secure, timely and cost-effective regulatory compliance in the implementation and maintenance of IT systems
- Fast and easy establishment of a compliant Quality Management System
- IT processes and procedures based on industry best practices
- The right quality level for your company, determined by a GAP assessment
- Customer confidence in your services and products
The compliance-in-a-box approach
Analysis:
- Compliance assessment:
- Scope and structure of the QMS
- Contents of the procedures and instructions
- Working practices that follow procedures
- Identifying potential compliance gaps
- IT processes review:
- Clarification of relevant IT processes
Development:
- Setting up new procedures and updating existing ones using NNIT templates based on industry best practices
Implementation plan defined by the following needs:
- Training of employees
- Communication strategy for changes in work processes
- Defining pilot projects to test the process framework
- Consulting for the practical work according to procedures