Data Integrity Challenges with Spreadsheets

Data Integrity App

 

The pharmaceutical and biotechnology industry continues to struggle with understanding how to validate and manage the integrity of data generated by spreadsheets.

One of the biggest challenges is the fact that companies normally don’t have an inventory of spreadsheets used for GMP operations. The lack of an inventory is a key indicator of the lack of knowledge of the number of spreadsheet that require validation and that must meet data integrity requirements.

This create a significant compliance and business risk because companies normally have spreadsheets that are not in a state of control and that don’t meet regulatory expectations related to validation and data integrity.

Another challenge is the fact that those legacy spreadsheets are not properly configured to enable functions that provide alignment with data integrity requirements.

Legacy spreadsheets that are not properly configured to enable data integrity and often lack adequate logical security, cell protection and technical controls needed to ensure the accuracy and integrity of the data during its lifecycle.

The following challenges are found in legacy spreadsheets:

·         Compliance risk

·         Business risk

·         Data integrity issue

·         Product quality risk

·         Risk to the patient


Spreadsheet data integrity can be compromised in a number of ways:

·         Human errors when spreadsheet data is entered

·         Errors that occur when spreadsheet data is transmitted from another application using macros or interfaces

·         Software bugs or viruses

·         Hardware malfunctions, such as disk crashes

·         Natural disasters, such as fires and floods

·         Lack of adequate security


One of the biggest spreadsheet data integrity challenges is the individuals responsible for data entry. Intentional manipulation of spreadsheet data has been found by regulatory agencies during inspections.

These include the following examples:

·         Malicious manipulation of spreadsheet data

·         Intentional deletion of failed spreadsheet

·         Intentional manipulation of failed spreadsheet data results

·         Manipulation of unprotected formulas and calculations

 

Procedure and technical controls are needed to ensure data integrity during the spreadsheet data lifecycle. The lack of procedure controls creates the risk of malicious and intentional spreadsheet data integrity issues. 

Need to develop strategies to address these challenges and reduce the risk associated with legacy spreadsheets these articles will discuss some strategies that enable data integrity.

“Trust but Verify “ Ronald Reagan

 

Across the internet, there are millions of resources are available which provide information about Everything.

 

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.


Comments

Post a Comment

Popular posts from this blog

Spreadsheet Validation Stages

Image
  Data Integrity App Documentation of the spreadsheet There should be a general description of the spreadsheet explaining its purpose, general layout, input types and data validation rules if required (some spreadsheet might be self-explaining). This description can be documented in the spreadsheet itself (e.g. in a dedicated sheet), in a SOP or in the validation file.   Next to the general description, a full print-out of the spreadsheet where all formulas are shown (Formulas tab > Show Formulas) should be kept in the validation file. When VBA 1 macros are used, the VBA code should also be printed and kept in the validation file. If matrix-formulas (array-formulas) are used, this must be indicated. An individual printout of each matrix formula is necessary All print-outs shall clearly identify the spreadsheet name or identification and version number. When a new version of the spreadsheet is being validated, a summary of the changes since the previous version...
Read more

Tips & Tricks for spreadsheet Validation

Image
Data Integrity App Tips & Tricks for spreadsheet Validation   A good road map and some tips and tricks can help you on your way through the rough landscape of spreadsheet validation. With all your experience, regulations, and guidelines in mind, develop a spreadsheet that includes all necessary requirements. Think of the following aspects: Use of the spreadsheet must be restricted to the intended user. Place the template on a (server) location with access limited to selected users. Protect the spreadsheet with a password that allows users to open the spreadsheet as read-only. You want to protect the spreadsheet against any undesired changes, so lock all cells within the spreadsheet (except the cells in which the user needs to give input). This way, the user cannot change cells with formulas, constants, labels etc. Give the input cells a color to make the spreadsheet more clear and easier to understand fo...
Read more