The use of Excel spreadsheets is part of everyday life in the pharmaceutical industry. Especially in biochemistry and pharmaceutical laboratories, they are indispensable for recording test results and values. When Microsoft Excel is used for GXP-regulated activities and quality-related tasks, these spreadsheets must meet specific requirements and validation of the computer systems and Excel templates is mandatory, because in the medical field this ultimately ensures patient safety.
If laboratory staff insert the measured values into an Excel template in order to compare the data with an analysis specification by means of calculations, there is always a certain risk that the calculations or changes do not comply with the guidelines and are incorrect or that formulas are overwritten by mistake. To prevent such errors from coming to light only during the next audit and causing major complications, or even requiring test series to be repeated because the documents do not comply with the regulations, it is absolutely sensible to have the used Excel templates validated by experts on a regular basis, especially because the underlying processes are always changing. Of course, the compliance of the computer systems and Excel templates is always first and foremost about ensuring that patient safety is maintained.
Excel validation as a Managed Service
We have developed Excel validations as a «managed service» to facilitate your work. We look at the Excel validation process from all regulatory perspectives and assume responsibility as well as monitoring of the entire lifecycle of the laboratory processes:
– Examination of data sets, variables and their relationships
– Evaluation of quality requirements
– Creation of a satisfactory catalog of validation rules
– Formalization of the validation rules
– Definition of key figures for data validation
– Testing and evaluation of the results
– Specification of the validation rules
– Verify data against validation rules
– Measure results
– Analysis of feedback from stakeholders
– Identification and prioritization of issues
Redesign, if necessary
In this way, you receive a ready-made template that already complies with all specifications and greatly simplifies your documentation work. Our expertise puts you in the best possible position for the next audit.
What does this mean in practice?
«Validation» of the Excel template means in practice that VBA coding, formulas and other algorithms used in the templates are thoroughly verified for correctness, accuracy and reliability. Both the files themselves and the calculations must be secured in such a way that the programmed formulas cannot be accidentally overwritten. Inputs in an incorrect data format must also not be possible or must be immediately indicated by an appropriate error message. In addition, it is important that the templates used and their previous versions are archived correctly so that changes can be clearly traced. We also ensure that your Excel tables meet all compliance requirements and are therefore GxP-compliant.
The following points are therefore relevant here:
- Display of system information (Excel version, operating system version)
- Protection of content that should not be changed
- Check function for input cells, with warning and error message in case of incorrect input
- Audit trail: control and record changes made in processes, the template should not be printed, but saved.
The validation of your Excel templates is performed according to your tested SOPs. We create a validation protocol for your specific case and carefully work through the points. This process consists of defining the specifications, testing, and documenting all operations in the final report, ensuring traceability. In the case of macros, separate code reviews are performed and documented.
Your advantages in a nutshell
If you use Excel templates in your laboratories in pharmacy or biochemistry, validation is often very complex and time-consuming. We take over the complete validation for you and this for the entire life cycle of the template. You can concentrate on process monitoring. In any case, you are well prepared for the next audit without having to invest a lot of work, time and nerves in advance. And, as already mentioned at the beginning, the most important aspect: patient safety is always ensured.
Your benefits at a glance:
- Your Excel templates always meet the latest requirements and are error resistant.
- You obtain your test results quickly and without complications.
- You have all the documents for authority audits: specification, testing and report are combined in one document.
- You save a lot of time and trouble.
If you are interested in our Excel validation service and would like to discuss special requirements, our expert Jan van der Heide will be happy to help and advise you competently.