A checklist does not replace a quality system. Used carefully, it turns a regulation or procedure into a sequence of actions that a small team can actually complete.
A practical sequence
Understand the regulatory requirements that apply to your operation (the authority and the activity — research, trials, manufacture or data).
Name the critical processes. Write a checklist for each one, with documentation templates where a record is required.
Build in good documentation practice: version control, who did the work, and how the record can be found later.
Train the people who will use the lists. Review them when the regulation or the process changes.
Put the lists in the workflow, not in a drawer. Use them for internal audits. Record nonconformities and the correction taken.
Add a short risk prompt: what can go wrong in this step, and what you will do about it. Include data-integrity checks for electronic records.
Limits
A checklist cannot certify a company, guarantee an inspection result, or substitute for competent people. It is a tool for making required work visible.