Vladislav Farsiyants

Product Specialist SEA Vision Rus LLC


In pharmaceutical industry the quality management system compliant with GMP requirements implies the adoption of Standard Operating Procedures (SOPs) to prevent errors and ensure the traceability of each operation.

Proving and tracing the compliance to GMP rules requires time, precision, and strict dedicated procedures. These procedures are designed to ensure the traceability of each operation concerning a specific production batch, in a sector where the product has a strong impact on the health and safety of people.
Pharmaceutical companies often struggle to daily fill all the needed paperwork but it is now possible to complete this task with a digital dedicated tool. The digitalization of these procedures allows, at the same time, to take care of the huge amount of documentation produced and to maintain constant control of production process.
The transition from traditional paper management to EBR - Electronic Batch Record - brings significant advantages in terms of compliance, cost reduction and archiving. Such an approach allows the reduction of errors costs, non-compliance costs, and operating costs as well as the reduction of production and batch release cycle times.