DHC Smart Validation Accelerator

Short innovation cycles combined with cloud computing – even for complex applications such as ERP or MES systems – present CSV with entirely new change management challenges. Technological innovations such as artificial intelligence (AI), generative AI (genAI), big data or data analytics and smart enterprise require dynamic, risk-based validation approaches. So-called SaaS and PaaS solutions with their regular updates require tool-supported, digitalized and automated solutions that keep the system in a valid state in a timely and reliable manner.
Traditional validation processes that rely on manual activities are time-consuming and error-prone. This not only leads to delays, but also puts you at risk of not fulfilling regulatory requirements on time.
Demographic changes are making the situation worse. The shortage of skilled workers in many industries is forcing companies to use existing resources efficiently and minimise the amount of work involved in recurring, manual activities.

Smart validation platforms support this with advanced data management, rapid adaptation to new regulatory requirements, and automated workflows and testing procedures that free up staff time for value-adding activities.
Regulatory requirements are also becoming more complex. New requirements, such as ensuring data integrity in accordance with GAMP 5 or the increasing importance of audit trails and electronic signatures, are difficult to implement with manual processes. Agile, smart validation solutions offer the advantage of providing seamless traceability, (real-time) monitoring and documentation support to ensure sustainable compliance.

Taken together, these factors create the need for a fundamental modernisation of the validation of computerized-based systems. Smart, tool-supported digitalisation and automation of validation creates the basis for fulfilling increasing requirements, minimising risk and future-proofing the company for the long term.