ICH R3: why an Excel sheet is not the best choice for ADRs managing

Many are the pharmaceutical companies that still store up pharmacovigilance data with spreadsheets.
As we often say to those who contact us, the entry into force of the new regulations is an opportunity to rethink company procedures. There are many reasons to leave Excel and switch to a native ICH R3 software. Here they are in detail.

 

1) The Excel does not have an intelligence developed for the adverse events management

Spreadsheets are not structured for the treatment of pharmacovigilance as they do not provide by default:
– advanced search for duplicates
– verification of the consistency of the data entered
– complex analyses with aggregated data
– signal detection

Every action necessary for the treatment of cases must be contemplated, planned and reproduced by juggling the limits of the Excel environment, so that the spreadsheet approaches the requirements provided by the regulations.

 

 

2) The spreadsheet requires a manual data entry: the error is around the corner

An Excel sheet lacks the automatic import function. The user is therefore forced to manually enter adverse cases into the document.

This implies:
– expansion of the processing times of each individual case
– activities with low added value
– probability of transcription errors

On the contrary, a dedicated software speeds up the procedure and safeguards against data-entering mistakes.

 

 

3) Reports are not automatically generated

Reports transmission to the Authorities becomes a laborious action. Since Excel is not a validated database, it does not issue reports that comply with accepted electronic formats. The processed data must then be entered manually in EudraVigilance.

Furthermore, it is not possible to generate all the regulatory reports necessary for carrying out the verification processes or for the external sharing of safety-relevant information.

A dedicated software, instead, integrates the functions necessary both for submission and for pharmacovigilance regulatory activities.

 

 

4) Spreadsheets are not a database

The manual data-entry into an Excel sheet requires a great deal of time and effort; archiving of additional documents (for example RTF or PDF attached to the case) is not possible; large numbers of cases are not easy to manage.

With a database, all processes are automated: storage is simple and straightforward, archiving and searching for adverse events is simplified and the process from the entering to the closing of the case is fully traceable with a digital signature for each change of workflow status.

The database is provided with coding tables containing E2B values and with lists of customizable items (Proprietary Medicinal Products, report receivers and mailing lists), which can be quickly accessible and without error.

 

 

5) The database is user-oriented

A database is not just an object limited to data-entry and storage object, but it is a valid, efficient and helpful tool. All analysis, such as signal detection, are performed without manual calculations thanks to special modules based on complex algorithms.

Another function present in the most advanced softwares is the message system. This is an articulated notification system via e-mail: it reminds the user of the activities to be carried out and prepares the transmission of specific cases in predefined circumstances.

 

 

6) Excel is not a web application

It means that the work environment in Excel contains tools that are not strictly necessary for the management of pharmacovigilance data and constitute a disturbing factor for normal operations.

The interface of a dedicated software is, instead, designed to facilitate the user in carrying out his/her tasks, providing exclusively targeted tools, intuitive functions and guided paths. The benefit is productivity.

 

 

7) Excel does not guarantee data integrity and protection

Use of the Excel sheet does not comply with international pharmacovigilance regulations. For example, it cannot integrate an audit trail, on the contrary a compliant software keeps a precise track of the database accesses, of each update and of the case advancement; it also allows the printing of a detailed report with the process history.

Operators could accidentally corrupt the contents of a spreadsheet and the data would be lost if not protected by an appropriate backup.

A safety database, unlike an Excel file, cannot be easily consulted, transferred and used on a USB key. Its higher security level makes easier the integration in company procedures on data protection required by the European regulation (GDPR).