Spreadsheet Validation Lifecycle

 

Data Integrity App 

Spreadsheet Validation Lifecycle

The simplified software development lifecycle (SDLC) for validating spreadsheets.

The principal features of this simplified SDLC, and key considerations for a cost-effective validation, are summarized below:


User Acceptance

The ‘final’ spreadsheet design is developed in conjunction with the end-user(s) via a ‘prototyping’ methodology.

Excel is an ideal tool for rapid application development and prototyping. In many instances the user will already have developed a “working” version and may even be in a position to submit the final design without modification.

This prototyping process allows flexibility, is amenable to change/improvement and ensures communication between the developer and the end user.

When a final design has been agreed by the user, the spreadsheet must be locked down and further development stopped.

Strong project management is required at this step to avoid the danger of ‘scope-creep’, the tendency of users to modify and extend their requirements throughout the project.

The recommended approach is to baseline the agreed version, and any subsequent requests for change are forced into a separate project.

Failure to manage this stage results in a never-ending “improvement” cycle resulting in no finalization of the validation


Spreadsheet Specification

A User Requirement Specification (URS) and Functional Specification (FS) are only produced once the spreadsheet design has been locked down.

The URS and FS are combined into a single document generated from a generic specification template.

The main body of the document is very generic, requiring only minor modifications for most spreadsheets, with a number of appendices containing the specific spreadsheet information.

Spreadsheet Specifications will be covered in more detail in a future article.


Spreadsheet Qualification

A qualification document is also produced once the spreadsheet design has been locked down.

This is developed from a generic document template with separate appendices covering functional testing, installation qualification, and operational and performance qualification.

The appendices provide flexibility to add additional specific test scripts for any ‘non-standard’ spreadsheet functionality; typically this would include functionality such as macros or data import/export.

The qualification document optionally includes a summary report sign-off page that acts as an authorizing report for final approval of the spreadsheet template.

Spreadsheet Testing/Qualification will be covered in more detail in a future article.

 


“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

Data Integrity Challenges with Spreadsheets

Image
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 securi...
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