In the life sciences sector, compliance is essential for both regulatory and patient safety reasons. The reality is that compliance is also costly and time-consuming, and it elevates levels of organizational risk. Compliance Digitalization mitigates those risks while reducing the costs and time required for compliance processes.
Traditional approaches to compliance are increasingly unfit for purpose, not least because of the evolving nature of regulations. Modernizing compliance processes through Compliance Digitalization is possible with tried and tested technologies and ways of working.
NNIT’s Compliance Digitalization expertise includes:
- Transitioning to Computer Software Assurance (CSA) while maintaining Computer Software Validation (CSV) best practices.
- Paper-to-glass transitions to digitalize previously paper-based processes and workflows.
- Digital audits that are both efficient and cost-effective.
- Batch integrity and quality control solutions.
CSV to CSA
We have expertise in CSV (computer systems validation) and CSA (computer software assurance) as well as helping companies develop new validation systems and processes that are aligned with both CSV and CSA principles. We support new and retrospective validation initiatives with expertise that includes:
- Software and computer system validation
- Process validation
- Equipment validation
- Test method validation
Paper-to-Glass Transitions
We can support your transition from manual, paper-based compliance and quality control processes to automated or semi-automated digitalized workflows. Examples include CAPA processes, digital document management, and improving the audit readiness of your facility.
Digital Audits
Our Smart Factory team has experience developing and implementing digital audit solutions that facilitate remote audits. In a Digital Audit, auditors, subject matter experts, and other key stakeholders can participate without traveling to your facility. This reduces the time, costs, and resources required to complete audit processes.
Key features of in-person audits are retained in a Digital Audit, including ensuring you maintain full control over document and data access.
Batch Integrity and Quality Control
Digitalizing and automating batch integrity and quality control procedures reduces human error, unnecessary delays, production bottlenecks, and waste, while also improving productivity, audit readiness, general regulatory compliance, and patient safety.
Our Smart Factory team can support the modernization of batch integrity and quality control processes on your production lines.
