I guess by now the rumors are true and the FDA has recently (late 2015) announced that it will begin much more stringent inspections for compliance to 21 CFR Part 11 regulations related to and concerning electronic records, audit trails concerning metadata, and signatures that need to be actual and trustworthy, plus validation of products.
So as a customer selecting a cold chain monitoring solution how can you be sure that the product you are getting will meet the requirements of this regulation.
There are simple pre-product selection questions that you need to ask your potential solution provider vendor about their products and the way they handle collected and stored data, plus how they validate these products to insure they are compliant.
Assuming that you are selecting a simple Go/No-Go device; it is always appropriate to ask if the data from the "original trip record" can be sent to a cloud data base, or other data storage solution, so that the trip data can be maintained for audit purposes in a secure mode - like encrypted PDF, which is tamper proof. Many Go/No-Go indicator devices do not offer the option of retrieving an original trip record, so therefore these devices would not be compliant - nor would you!
In the case of data loggers; most models of data logger that have a memory and are not just Go/No-Go devices will have the capability to produce a PDF report either directly upon loading to a computer USB, or by connecting the logger to a computer device that has a preloaded application to download the data to create the PDF.
However, it is important to ask if the PDF file is in an encrypted format that cannot be manipulated and shows all of the route data including the metadata used to create it. This will insure compliance and meets standards related to USP regulation 1079 to prevent manipulation, and also to meet the guidelines for complying with 21 CFR Part11.
It should be noted that not only should the logger meet these standards for data security, integrity, and validation requirements, but any cloud databases, or other forms of databases, used to store this data must also meet the 21 CFR Part 11 requirements for tracking changes, audit trails, signature compliance, validation, etc.
With so many data logger products on the market and the need to insure you are obtaining a product that meets all related regulations - not just domestic, but globally, as a customer you need to ask these important questions to avoid any non-compliance issues when audited.
DeltaTrak has a 26 year history of providing industry regulation compliance products for both Life Science and Food and Produce. We have been audited by many of the large pharmaceutical companies and each time this has been completed with no major non-conformance issues.
February
17
2016
Category: Blog,Compliance and Risk Management