A well developed Quality Manual customized to your company’s needs is a valuable tool in achieving regulatory compliance. VSI can write a Quality Manual for your company that will establish corporate quality policies and responsibilities, outline the requirements for compliance, and provide an overview of your Quality System.

VSI can develop customized SOPs to support your Quality System and ensure regulatory compliance. We can work with your Quality Department to develop procedures that are easy to follow and meet your specific needs.

These procedures include the following:

• Change Control/Document Control, Processing, Archival
• SOP Format/Numbering
• Master Batch Records
• Test Methods
• Equipment SOPs
• Personnel Training
• Documentation Practices
• QA Audit Program
• Receiving
• Receiving Inspection
• Material Status Labeling
• Validation Policy
• Lot Numbering
• Manufacturing Line Clearance/Start-up
• Equipment Calibration/Maintenance/Logbooks
• Variance/Deviation
• OOS
• CAPA
• Failure Investigation
• Non-conforming Material Control
• QC Sampling
• Product Release
• Record Retention
• Product Retentions
• Facility Inspections by Regulatory Agencies
• Corrective Action
• Change Control for Validated Systems