The regulations don’t require that the author or (any/all) reviewers approve.

Keep Reviewers to a Minimum

When deciding on approvals, keep it to a minimum, only involving critical stakeholders.

Examples

For example, for top-level SOPs, maybe only Quality and a Management representative need to sign.

For Verification protocols, maybe only Quality and the R&D Lead need to sign. Many companies get themselves in quite a bind, requiring approval from a representative in every department. The optimist says this is to ensure consensus. The cynic sees it as a means to spread the blame. Either way, the resulting effect is that it can greatly delay the process.

Signatures Constitute Legal Action

Signatures constitute a legal action so the signature should be the same as how the person signs a check or credit card transaction.

Initials

Initials (shown in Figure 2) are quicker and more convenient but may not be acceptable for some documents. Make sure you comply with the requirements and internal policy.

In some cases, initials can be used when “tied” to a signature. For example, a verification protocol that has (many) multiple pages for data entry can be initialled if there’s a signature (e.g., on the cover) and initials indicating the signature and initials are equivalent (for the remainder of the document).