Project/Validation Preparation

Data Integrity App

 

Project/Validation Preparation

Project planning is essential for the successful execution of any validation exercise. This is particularly true when embarking on spreadsheet validation.

It is likely that a large number of spreadsheets will be involved and therefore efficiency and repeatability are critical factors in the validation process; the key to the efficiency and minimizing the validation costs is to keep the process simple.

This is achieved by introducing streamlined processes throughout the validation lifecycle, and the use of a generic yet adaptable set of documentation.

It is essential that the validation process is documented and commonly this may require a formal Validation Plan to satisfy local procedures.

Alternatively it may be possible to document your process in other project documents such as Standard Operating Procedures (SOP) or the Spreadsheet Specification.

However, one of the biggest strengths of a Validation Plan (and subsequent Validation Report) is that it presents an excellent “condensed” document set to present for an inspection.

It demonstrates you have a well thought through and controlled validation process, and the Report summarizes the outcome and validated status of your spreadsheets.

For any project with more than a few spreadsheets a Validation Plan is highly recommended. A formal validation plan should where possible cover all spreadsheets in the company/department.

This can be achieved by cross-referencing the spreadsheet inventory as a separate ‘living’ document. The production of separate validation plan for each spreadsheet should be avoided – this is simply duplicated work and additional documentation.


 “Trust but Verify “ Ronald Reagan

 

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If you found all content under one roof then it will save your time, effort & you will more concentrated on your important activity.

Data Integrity App


 

Our Data integrity app will helpful for understanding what Data integrity & CSV really means & How 21 CFR Part 11, EU Annex 11 & other regulatory guidelines affects in pharmaceutical Industry.

 

Data Integrity App Include 

- Basic Data Integrity Concepts

- ERES & Its Requirement

- CSV & Its best practices 

- Mock Inspection and General Q&A

- Checklist for inspection

- Inspection Readiness

- Useful SOP’s

- Stay Regulatory Compliant.

 

“Stay One Step Ahead in Pharma IT Compliance” 


Data Integrity App Link:


https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity

 

Try our "Data Integrity" app which helps you to better understand current regulatory agencies thinking on Data Integrity & CSV.


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