Technical Controls of spreadsheet

Data Integrity App

 

Technical Controls of spreadsheet

In order to meet specific regulations, for example audit trails within 21 CFR Part 11 [5], it may be necessary to add additional technical controls to Excel.


These controls can normally be added in one of two ways.

• Custom developed macros and functionality provided either on a spreadsheet by spreadsheet basis, or as a generic module which is added in the same format to multiple spreadsheets.

These customized developments will generally be classed as GAMP category 5 software [8], and as such merit a rigorous validation effort due to the risks associated with customized application and coding.

• Third party software packages that add additional technical controls to the Excel environment. These off the shelf software packages will generally be classed as GAMP category 3 / 4 software8, and as such require specific validation.

When either of these “add-on” options are implemented, the project should be planned such that the validation effort be performed only once for the add-on.

Each subsequent spreadsheet validation should then reference the add-on validation. The investment in additional, extended validation of these types of add-on components is usually repaid as it reduces the effort required to show security and traceability on each individual spreadsheet.

The larger the spreadsheet inventory, the more beneficial these options become. These options are most commonly used to comply with the necessary technical controls of 21 CFR Part 11.

 A typical spreadsheet validation project would include the installation of these additional controls, combined with the implementation of multiple spreadsheet templates.

An example process for a project incorporating the DaCS addon9 is depicted in Figure 2. The validation of the technical controls is only performed once; the validation of these add-on features can then be referenced on the streamlined validation of each spreadsheet.


“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

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