By: Anthony Newcombe, Principal Consultant, PAREXEL Consulting
Excel spreadsheets are commonly used within pharmaceutical Quality Control (QC) laboratories, particularly for early stage development or if an electronic Laboratory information Management System (LIMS) is not used for the recording and management of laboratory data. Excel spreadsheets are often used to track sample receipt, evaluate trend analysis or to provide consolidated lists of analytical results that may need to be accessed by other departments or functions to assess process performance or to support process development activities, such as Research and Development. The use of Excel spreadsheets within a pharmaceutical QC laboratory can be challenging, because the software has not been developed for use within a GMP regulated environment, and therefore spreadsheets do not typically meet the regulatory expectations associated with data integrity or provide assurance that the results are valid and will protected from inadvertent changes. Excel spreadsheets therefore usually require some custom modification using macros to provide data control and protection to be considered fit for purpose. Specific requirements include locking of cells in the spreadsheet that are not needed for data input, use of password protection and ‘read only’ access and features to verify and document spreadsheet calculations. The addition of an audit trail function to an Excel spreadsheet for use within pharmaceutical laboratories is often perceived to be challenging and complex due to the need for the development of a custom macro that will generate an automated log of specific changes. Here a simple example is presented that can be used to add an audit trail function to an Excel spreadsheet.
An Excel table was created using an example audit trail spreadsheet available online (VBA tips, ExcelExperts.com) showing fictional analytical test data for product attributes typically included as part of a biopharmaceutical development program:
Changing information on the spreadsheet results in a log entry with the user and details of the change. For example, changing the purity value from 99.2% to 99.4% results in an automated log entry:
PAREXEL’s Strategic Compliance and Risk management team leverages decades of experience in detecting and preventing data integrity issues. Our consultants include former regulators and industrialists, including laboratory GMP compliance experts. To request a no obligation proposal to assist with computer systems validation, data integrity or any other GMP compliance support please contact Anthony Newcombe PhD, Principal Consultant, PAREXEL Consulting, email@example.com, +353 (0)876325310.