absolutely agree with wes.. but I wish to add an important qualifier, its not what the records or forms look like- its how you treat them. The standard makes it clear that procedures and records are to be controlled.
controlled meaning that
- the documenation is approved and that only the latest approved documenation (be it procedures or forms) are used
- revisions are tracked. documents must be identified in such a way that you can prove that any given document is the lastest revision
- the documenation is approved and that only the latest approved documenation (be it procedures or forms) are used
- that documenation is kept in identified, protected places for at least a specified retention time
many organizations will include some formatting to show revision #, identification, and location (be it book # or whatever). The system then tracks how you control your documenation could create formatting, or other storage requirements.
Surely a great way to handle documenation is to set up an all electronic system to store work instructions. This will not create so exactly a 'standard' work instruction, but it may specify that the work instruction is written within a word processor application and has a page or other formatting to indicate revison #, identification, approval, etc.
more complex software allows you to store records on the computer and provides software to create a unique, traceability electronic signature. We make FDA grade product BUT are pretty low tech, so we may never go there...
PS. I have restrained myself from quoting the standard.. since the standard is copyrighted-- it would be bad to quote it, correct??