The Guidance Document supports the redesign process by establishing “best practices” for the format and content of batch record and device history record documentation for a site or across sites. The Guidance Document:

• Ensures uniform, consistent documentation practices
• Outlines cGMP requirements for documenting process(es)
• Includes internal company requirements and regulatory commitments
• Simplifies the creation of new or revised documents
• Provides cross-site harmonization
• Provides training and justification to personnel involved in documenting and reviewing the records
• Simplifies new product introduction, tech transfer and product transfer process, migration to EBR/MES

"the Guidance Document establishes 'best practices' and cGMP requirements for batch documentation"