FDA is now preforming QSIT Inspections and recent policy changes will result in more frequent inspections. FDA has found numerous CAPA, design control, and Management deficiencies during inspections and will focus on these subsystems. An increase in 483s, Warning letters, and other enforcement activities is expected. Current internal auditing practices may be obsolete.
Executive management is legally responsible for quality.
Prepare for new software standards and guidance which will be released. Prior inspection preparation is critical for success. FDA Investigators are now inspecting Design Processes and Electronic Recordkeeping Systems . Civil Penalties being assessed Companies and individuals Failure to comply with Electronic Recordkeeping Regulation may result in significant GMP violations. In-house recordkeeping and documentation systems may be at risk.