Validation Plan

Procedures in this standard may be used to validate conformance to requirements of the following:

• End items.
• Components or basic materials.
• Operations or services.
• Materials in process (cleaning, sterilization, preservation, etc).
• Supplies in storage.
• Maintenance operations.
• Data or records.
• Administrative procedures.

It Provides information:

• Scope.
• Product Requirements.
• Limitations.
• Recommended Reading.
• Order of precedence.
• Definitions.
• General
• Quality System.
• Validation Overview.
• Elements of a Validation Program.
• Factors that affect product quality.
• Process Validation Tools
  • Process Improvement.
  • SPC.
  • SPC Planning.
  • Process knowledge.
  • What to measure.
  • Normality.
  • Control charting.

Who will benefit:

• Technical Manager.
• Quality Manager.
• Maintenance Manager.
• System Analyst.