Data Integrity & Computer System Validation Workshop 2021

Course Overview

DATA INTEGRITY

Data Integrity (DI) has become a focal point of FDA inspections, as is evidenced by the number of warning letters citing data integrity and the resulting number of import alerts. With increased reliability on computers and automated systems, it is extremely vital for a pharmaceutical organization to ensure efficacy, quality and safety of drugs. Company Quality Management Systems are being scrutinized as to how the integrity of raw data (both electronic and manual) generated in the Quality Control Laboratory and in Operations (Manufacturing and Engineering) can be assured.

COMPUTER SYSTEM VALIDATION

It has been well over 15 years since the US FDA issued their last guidance on Computer Systems Software Validation. Since then, the computing and controls technologies have undergone a significant evolution to include Cloud Computing, Agile Software Development, Paperless validation, Mobile Computing, Artificial Intelligence, Lab Robotics System etc.
Validation of computer systems has become imperative over the last decades as it plays a vital role in getting compliant with GAMP guidelines. As there are latest tools & technologies available to validate computer systems, pharmaceutical manufacturing companies have to meet regulatory guidelines and expectations to avoid 483s and pass regulatory inspections.