#GAMP CATEGORY 1 EXAMPLES SERIES#

4 However, the diagram is, to my mind, only focused on instruments and computer systems, and I have drawn up a more detailed description of what should be presented in a data integrity guidance, see Figure 1. The spectrum of data generation is purported to be represented by Figure 1 in the guidance, which turns out to be a diagram drawn by Monica Cahilly during the April 2014 training of the MHRA inspectors. This section of the guidance first discusses the data governance system that we discussed above and then moves on to look at data generation. 3 In this part, we will look at data criticality and the data life cycle.Įstablishing Data Criticality and Inherent Integrity Risk The second part reviewed and discussed the data governance system.

#GAMP CATEGORY 1 EXAMPLES SERIES#

1 The first part of the series 2 provided a background to the guidance document and discussed the introduction to the document.

Up next: validation and operation strategy for each category.This is the third of a four-part series reviewing and critiquing the recent Medicines and Healthcare products Regulatory Agency (MHRA) guidance for industry document on data integrity. And as always, do more when risk is high, do less when risk is low. After classifying the object into the appropriate category, we need to assess the impact of those risks on the quality system. The complexity level increase over category, as well as the risks. I used this type to manage the validation status that the data need to take from several files.

Category 5 contains spreadsheets with custom macros, VBA macros, lookup function (INDEX, MATCH, VLOOKUP, LAMDA.) combined boolean function with more than 3 brackets power query, sophisticated database.Sometimes for simple data analysis like capability study, Individual charting, I used this type of spreadsheet. Category 4: Complex spreadsheet/template with limited statistical functions (AVERAGE, STDEV, MAX-MIN, COUNT, VAR.) simple boolean functions that contained not more than 3 brackets (IF, AND, OR, SUMIF.).This can be used as an inventory sheet, bill of material, a calculating sheet in QC laboratory. The object in this group must have no custom VBA modules or customized functions, no Boolean functions. Category 3: Simple spreadsheet with limited intended use for arithmetic calculation, range operation, template, cell relationship, and printing function.For validation testing, I prefer Minitab with powerful built-in statistics & quality functions. The most popular option is Microsoft Excel, Access. Category 1: The product upon which the application is built.The best methodology to be used is GAMP 5 for End User Application: Classification must be based on the complexity level of the spreadsheet. The first action to dealing with the spreadsheet is classification. Here is something that I learned, and I am happy to share with the network: I once lowered the aversion for those risks and immediately got punishment from the auditor. But the common spreadsheet application is not designed for GxP compliance, and when using them, there are always several relevant risks. It's can be used as a hand calculator, a timesheet, a bill of material, a form, or even a database. Spreadsheets have various applications in the GxP environment.

Gamp category 1 examples