Complying with 21 CFR Part 11 Rule; Plan and Issue in Pharmaceutical Companies

Abstract

  21 CFR Part 11 rule has been effective since August 1997. Pharmaceutical companies are still investigating how they comply with the rule. To comply with the rule around the current circumstances, pharmaceutical companies need to develop a compliance implementation plan, and establish company policies and procedures for compliance. Each site or division should prepare a site/division implementation plan and execute the plan for inventory list, assessment, procedural control and technical solution. From my viewpoint, I will describe some issues for pharmaceutical companies on scope, hybrid system, audit trail, long term retention of records, access control, and implementation plan.