FDA does not have a separate regulation for large pharmaceutical companies as opposed to a smaller operation. The regulations have to be flexible enough to adapt to each situation.
FDA has an old mantra, "if you didn't document it, then it didn't happen." Records are a cornerstone for evaluation of compliance with cGMPs. Records are tools for control of those highly variable parts of the manufacturing process - humans - and are evidence to support a companys assertion that what they are saying actually occurred. If, for example, youre doing a pre-approval inspection and the exhibit batches were manufactured years ago, the documentation is important. There are specific requirements in the CFR for when, why and how a company needs to have documentation.