Understanding 2015 Data Integrity Regulatory Requirements for Temperature Controlled Pharmaceuticals
The UK Data Integrity Guidance states raw data must be «legible and accessible, retained in the format in which it was originally generated, throughout the data lifecycle». From a business perspective, we know that raw data generated in the supply chain is valuable to understanding its performance – if handled correctly. But how? It’s more efficient to ensure raw data is connected to the original data record, which is certainly done using a relational database. If you’re manually processing flat files, it can be resource intensive to review numerous spreadsheets for example, and more subject to error when archiving and storing paper records or flat files.
That is just one example how there are different ways to set up your temperature monitoring program. Each way may offer unique business benefits and options for data integrity. Data loggers, types of files, raw data, and a database – all work hand in hand to create a cohesive process-driven system. As you establish your monitoring program, consider how to achieve both compliance and your business needs … by making the right choices.