Outline the requirements and strategies for creating a compliant Excel workbook.
Spreadsheet software is a powerful tool for processing data. This allows it to be an extremely useful asset for the pharmaceutical industry, however, it can also be a huge risk. Each year citations from regulatory bodies inspecting pharmaceutical labs are given out to companies for their use of un-validated spreadsheets. While almost all professionals in the industry have some degree of experience with spreadsheet software, the level of technical ability varies greatly from user to user. Excel spreadsheet validation creates a standard that is acceptable for all associates involved in the project.
In a Q&A issued by European Medicines Agency: “Validation according to paragraph 4 of annex 11 is required at least for spreadsheets that contain custom code (e.g. Visual Basic for applications). Formulas or other types of algorithm should be verified for correctness. Therefore, appropriate controls for templates of spreadsheets must be in place. Erroneous calculations due to data remaining from previous calculations must be avoided. The templates should also be suitably checked for accuracy and reliability (annex 11 p7.1) and should be stored in a manner which ensures appropriate version control (chapter 4 p4.1).”
There are many hurdles to making spreadsheets compliant. The following are just a few of the common issues that must be addressed.
Successful validation is dependent on proper planning and procedures being in place. It is likely that a large number of spreadsheets will be involved and therefore efficiency and repeatability are critical factors in the validation process; the key to efficiency and minimizing the validation costs is to keep the process simple. This is achieved by introducing streamlined processes throughout the validation lifecycle and the use of a generic, yet adaptable, set of documentation. This includes validation SOPs, usage SOPs, and Validation Plans.
The spreadsheet should be designed with compliance in mind following established documented procedures. However, it is common that a spreadsheet has already been created and is in use before the decision to validate is made. The FDA has issued the following requirements as a guide to validating spreadsheets:
Each company has different approaches to Excel spreadsheet validation. Regardless the method (Validation Plan vs. SOP), the following points must be addressed at minimum:
The following information is key to document as proof of the validation effort:
The validation of spreadsheets often gets overlooked on the priority list but is crucial to avoid regulatory issues. There are many resources available online to guide first time validators through the process. SciCord provides services and products that can fulfill these validation needs. Please contact us with any questions you may have regarding spreadsheet validation.