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7 QUICK TIPS ABOUT EXCEL SHEET OPERATION (GxP/GAMP)
21-08-2018

#7 QUICK TIPS ABOUT EXCEL SHEET OPERATION (GxP/GAMP)

You have built a fantastic Excel sheet and successfully finalized the validation. However, are you able to use/operate your Excel sheet and keep its flexibility and familiarity that comes with it up to date as well? In addition, preferably without suffering from validation chaos? In this blog, we’ll explain how to do just that.

“No matter the popularity of spreadsheets, when used improperly or incorrectly, or without sufficient control, spreadsheets pose a greater threat to your business than almost anything you can imagine.” – Phillip Howard, Boor Research

First off, is your Excel sheet validated already? If not, you might want to start out by reading our previous blog:

 #6 Quick Tips About Excel Sheet Validation

After you have finished this one you want to ask yourself the following questions:

  • Are you confident with the fact that your Excel sheet is validated?
  • Have you already created your User Requirement Specifications and performed your Installation and Operation Qualification?
  • Is your Excel Sheet Validation Report already approved?

Thinking about these questions, make sure that your validation documentation is complete and covers all applicable regulations and guidelines. As soon as this is accomplished, your Excel sheet is ready for deployment and ready for its operational phase.


1. QMS Documentation

First, make sure that all necessary QMS (Quality Management System) documentation for the maintenance of the Excel sheet is present and up to date such as Incident Management, Audit Trail Review, Periodic Review, etc. The frequency for the periodic evaluation of these procedures should be determined based on a Risk Assessment.


2. Inventory list

Additionally, an inventory list may provide you with a clear overview of all your Excel sheets. Your inventory list may contain:

  • Spreadsheet name and number
  • Current version
  • Area(s) where used
  • Spreadsheet Owner
  • Location of the template

By noting down these items the list will help you to keep track which Excel sheets have been validated, where they are being used, and for what.


3. Infrastructure

Is your Infrastructure qualified and in a state of control that would satisfy your Excel sheet validation? Once the validated Excel sheet is in its operational phase, all records and evidence produced to meet the regulatory requirements must be stored and/or archived over the entire lifecycle of a product, often over decades. Therefore, it is always good to think about the building of your infrastructure and check if it can provide a huge amount of data e.g on a daily basis.

4. Implementation


Now you can start implementing your Excel Sheet. To achieve that, follow your deployment procedure and make sure that your validated and approved Excel spreadsheet has been released properly. Store your template and the data entered into the spreadsheet in a secure location with access limited to selected authorized users. If your site policy requires storage of an electronic copy of the Excel sheet application file, the file should be stored under a new name in a designated area on the server.


5. Operational reliability & Training

To be able to demonstrate (to inspectors and auditors) that your Excel sheet is always in compliance during its operation you may need to have in place:

To be able to demonstrate (to inspectors and auditors) that your Excel sheet is always in compliance during its operation you may need to have in place:

I. A User Administration Procedure which should include:

  • Access/security levels available for the Excel sheet
  • How to change user roles and rights

II. A User Work Instruction which should provide information about:

  • How to operate the spreadsheet
  • Where and what kind of data should be entered
  • How to process your final results

III. Training

  • You should be able to provide a documented evidence that all appropriate employees are adequately trained

6. Traceability, Changes Management & Inspections

Even a perfectly validated Excel sheet needs changes from time to time, for example, due to changes in your working method. You should always document all changes made in the Excel sheet, as part of the change control, and keep track of these changes using version numbers. This ensures that each version is easily referenced and traced. Never delete older Excel sheet versions. Old versions should be decommissioned and stored separately from the active ones. This is important for tracking changes, mistakes, etc. and is a major point to regulatory authorities during their inspections and audits. The inventory list may help you to keep track of traceability of all changes performed on the Excel sheet.


7. Risk management & Re-Validation

Is it necessary to re-validate the Excel Sheet after a change has been performed? When and what do you need to re-validate?

In general, any change performed on a validated Excel sheet template may cause a significant harm, especially during operation and maintenance. In order to be able to analyze possible impacts on Patient Safety, Product Quality and Data Integrity, you should perform a detailed Risk Assessment as well as intensive validation support to maintain compliance and to recover the validated status. A risk-based approach helps you to define which parameters of the application are critical and reduce their risk to the minimum. The result will help you to define your validation effort. If the risk assessment determines that the change is minor or does not affect the spreadsheet requirements, only limited testing, focused on the affected system object, would be required to demonstrate that the system has maintained its validated state. Major changes will require additional re-validation and critical changes could trigger and demand an entire re-validation of the Excel sheet.


Conclusion

It doesn't matter whether your Excel sheets are used for the administration of production equipment, recording and graphical presentation of cleanroom monitoring data or for conducting statistical analyses in quality assurance. Once these activities are related to GMP requirements, your Excel sheets need to be validated and will most likely draw the attention of any inspector and/or auditor. In consequence, regulatory requirements must be met in a reliable way during and after validation while the effort is kept within limits.

So, wrapping up here’s the list key points to look into when developing, validating and maintaining your own Excel sheets for GxP environments:

  1. Availability of all QMS & Validation documentation following GAMP (Good Automated Manufacturing Practice)
  2. Creating an inventory of all your Excel sheets
  3. Building a secure infrastructure
  4. Reliable Excel sheet implementation
  5. Operational reliability & Training to users
  6. Traceability & Change management, and inspection readiness
  7. Risk Management & Re-validation

Keep in mind that this blog isn’t meant to be exhaustive and we encourage you to contact us if you have any remaining questions!

Blog by: Silviya Della Chiave


NEW: We invite companies who are looking for an efficient way to validate their Excel sheets in an optimal way. You provide the necessary information and we'll provide you with a compliant sheet. Check it out!



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