Winchester Business Systems, Inc. has developed a methodology and a doctrine that assists clients in becoming compliant with Part 11.

Tasks begin with taking inventory and gathering facts about the present environment and systems. Appropriate assessments of coverage and risks are accomplished next followed directly by a Gap analysis. Once the Gap analysis is complete, the client and Winchester team develop a plan for (1) mitigation of the procedural controls that may be corrected for the short term, (2) remediation resulting in a long-term plan for improvement, and (3) maintenance of the now-compliant environment.

For additional information, please contact us or call 781 503-0200.