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Checklist that will helpful in your next Inspection Part IV

Checklist that will helpful in before Inspection 11 Prioritize Areas of Scrutiny With the list of potential questions and possible documentation to provide, it is time to prioritize likely inspection points. Identify between 5-10 likely areas that will be reviewed. For instance, if the review indicates the agency is concerned about management involvement and supportContinue reading “Checklist that will helpful in your next Inspection Part IV”

Checklist that will helpful in your Next Inspection Part III

Checklist that will helpful in before Inspection 6 Review the Notification Letter With luck, the letter will spell out the type of inspection the Agency intends to conduct, including the records the inspector expects to review. This may be a preapproval inspection (PAI), “statutory” inspection, a “for cause” inspection or a “follow-up” inspection. In suchContinue reading “Checklist that will helpful in your Next Inspection Part III”

Checklist that will helpful in your Next Inspection Part II

Before Inspection Checklist Much of the work needed to ensure that the inspection ends successfully should be completed long before the FDA Investigators arrive. All companies should begin work immediately to ensure that they have accomplished all the critical tasks. 1 Notify all staff /employee & contractual if pre plan/routine inspection: Notify the Sponsor ofContinue reading “Checklist that will helpful in your Next Inspection Part II”

Checklist that will helpful in your Next Inspection

In Earlier post we understood What FDA will expect from your Next Inspection. Now in this article we are going to understand Checklist that will helpful in your Next Inspection “By failing to prepare, you are preparing to fail” – Benjamin Franklin Proper preparation and planning prevents poor performance. To avoid any observation Check list play vitalContinue reading “Checklist that will helpful in your Next Inspection”

What is System Deliverable Matrix & Its usage in Computer System Validation?

In Earlier post we understood what is Checklist which useful for Computer System Validation Documents Preparation & Review. Now in this article we are going to understand What is System Deliverable Matrix & Its usage in Computer System Validation? What is Deliverable? A deliverable is any unique and verifiable generated results, or capability to perform a serviceContinue reading “What is System Deliverable Matrix & Its usage in Computer System Validation?”

Final Checklist which made your Computer System Validation Documents Preparation & Review Easy

In Earlier post we understood what is System Release Certificate (SRC) in computer system validation? Now in this article we are going to understand Checklist which useful for Computer System Validation Documents Preparation & Review. The checklist items provide a frame of reference for users and auditors to better determine potential compliance issues with computer systemContinue reading “Final Checklist which made your Computer System Validation Documents Preparation & Review Easy”

What is System Release Certificate (SRC) in computer system validation?

In Earlier post we understood What is Validation Master Plan, Its content & Regulatory requirement in Computer system validation? Now in this article we are going to understand what is System Release Certificate (SRC) in computer system validation. What is System Release Certificate (SRC): System Release Certificate (SRC) is authorizes the release of System forContinue reading “What is System Release Certificate (SRC) in computer system validation?”

What is Validation Master Plan, Its Content & Regulatory Requirement in Computer System Validation?

In Earlier post we understood How to Conduct a GAP Assessment in Computer System Validation process. Now in this article we are going to understand What is Validation Master Plan, Its content & Regulatory requirement in Computer system validation? What is Validation Master Plan? EU GMP Vol. 4 Annex 15 says: “The key elements of aContinue reading “What is Validation Master Plan, Its Content & Regulatory Requirement in Computer System Validation?”

How to Conduct a GAP Assessment in Computer System Validation process.

In Earlier post we understood What is Validation Summary Report in Computer system Validation Now in this article we are going to understand How to Conduct a GAP Assessment in Computer System Validation process. What is GAP Assessments? GAP is nothing but difference between actual state and desired state. A way to compare current conditionsContinue reading “How to Conduct a GAP Assessment in Computer System Validation process.”

What is Validation Summary Report(VSR) in Computer System Validation

In Earlier post we understood How to handle Discrepancies during Computer System validation? Now in this article we are going to understand What is Validation Summary Report in Computer system Validation What is Validation Summary Report: Validation Summary Reports provide an overview of the entire validation project. It is summary of all planned activities, their success orContinue reading “What is Validation Summary Report(VSR) in Computer System Validation”