Going by the FDA 21 CFR Part 11 Checklist is a good way to stay on track
It makes sense for organizations that are part of 21 CFR Part 11 to have a checklist of requirements, as this helps eliminate thorny issues.
There is considerable confusion about the requirements of electronic signatures set out by 21 CFR Part 11. Many organizations get confused about areas like the mode of signatures, as there are different requirements for electronic and paper formats of the same regulation. In order to resolve confusion arising out these and other issues, making an FDA 21 CFR Part 11 checklist is a good solution.
The benefits of charting out an FDA 21 CFR Part 11 checklist are many:
- It acts as a guideline in helping organizations comply with the requirements set out in this regulation;
- It helps to overcome oversight, as there is a fairly high possibility of its occurrence;
- It helps to put necessary and appropriate regulatory requirements and standards in place to tackle the huge list of requirements in this regulation.
Going by this checklist is of immense value to organizations
The numerous advantages of EHRs notwithstanding; some concerns abound about its usage.