Lack of Compliance Features  - Security:              Files are stored on local hard drives or network                              servers, and may be easily accessible to unauthorized                              individuals. - Audit Trail:          There are no audit trail of changes made to the file,                               even when made by authorized personnel. - eSignatures:         There is no provision of electronic signatures. - Version Control:  There is no provision to create a controlled version                               for each modification made to the file. FDA Inspections, 483's and Warning Letters GxP (GLP, GMP, GCP) reports generated by word applications are electronic records and should comply with FDA’s 21 CFR Parts 11/58. For critical records 21 CFR Part 11 controls should be implemented. Most critical are data integrity, data accuracy, audit trails and electronic signatures. Currently there are no specific FDA guidelines on using word applications utilizing macros and VBA in regulated environments. On the other hand word based applications using VBA and macros have been audited as part of FDA inspections and many warning letters have been issued. While the original inspection resulted in several observations and a warning letter, the findings from the follow up have been accepted and can be considered as good practices for using word applications in FDA regulated environments. Damaged reputation Using word based applications that are not completely validated, in a non-compliant mode can damage your company's reputation and even delay FDA's approval process. Productivity Loss  Legal costs and fines, damaged reputation issues all negatively affect your efficiency and the efficiency of your employees.
				1. Risks 2. Benefits 3. Are You at Risk? Quiz 4. System Requirements 5. Validation Requirements Compliance