Excel, my beautiful Excel tell me if you are really so convenient and secure to manage all deviations, Corrective and Preventive Actions (CAPA) or Change Control in our production site. Obviously not! So Excel to the trash? More reliable processes for safer and more efficient quality! Find out hereunder why a CDMO has interest in computerizing its Quality management processes.
Unless you lock your file and give writing permission to a very limited number of people (so concentrating activity on them, usually on the quality department), Excel is not a secure tool to reliably track deviations and CAPA. No one is sheltered from a line or cell content deletion. No traceability is ensured then.
Moreover, in order to trace in real time the deviation declaration or a CAPA, the paper use is unavoidable. The handwritten data are then filled in Excel. The paper remains the raw data support. But the paper is lost, torn, destroyed. At the time of Data Integrity, in this case the raw data is no longer reliable…
Unreliable information, truncated processes or inadequate monitoring can compromise quality certification.
In order to remain competitive in the international market, manufacturers must manufacture quickly good quality products at the lower cost. Quality management is far more complex for companies that meet the regulatory standards such as ISO, GMP and FDA. Quality management software enables the electronic quality processes set up and significantly improves their production efficiency as well as their compliance with these regulatory standards.
The computerized quality management software allows you to quickly and efficiently connect all services on the plant. Each collaborator, having his own access, has the possibility to step in the system. Thanks to computerized workflows (qualified, secured), it is possible to answer quickly to requests from other services. So if we take the example of managing a CAPA in a quality management software, the CAPA form can be launched directly from another form (eg a deviation), relevant data being automatically integrated in the CAPA form, which limits the data entry and avoids any mistake due to the manual information transfer as it might be the case with an Excel file and a paper form.
These workflows enable operational teams to interact with the system, guide them from problem identification to corrective action, and no longer leave the Quality teams alone to solve problems.
Without automation, systematic recording, routing, and verification of process completion or approval can quickly become a baffling problem.
Quality management software has powerful reporting capabilities that help to improve system monitoring. Each actor has a real-time view of their workload (current or future). This global and complete vision of their actions (via, among other things, electronic targeted notifications) enables deadlines to be met in the best possible conditions.
So for a CDMO like us the choice is made! And we overcame and left our dear Excel.