Refractometer Data Storage – Applies to Rudolph Research J257, J357, and J457 Laboratory Refractometers
All Rudolph refractometers are equipped with a control system using Windows 7 embedded. This control system has 32mb of on board memory which is extendable using USB sticks. The control system can also be hooked directly to a network making the data storage effectively infinite. No computer is needed for an on board solution, the instrument is operated through the supplied touch screen.
Embedded – None
In this mode no date is stored. The instrument displays the reading long enough for a user to record it in a note book or print it of course but when the next measurement is started the previous measurement is gone forever. This mode is primarily use by pharmaceutical labs wanting to use paper records and not get caught up with 21 CFR 11 compliance issues.
Embedded – Unsecure
In this mode all readings are stored in the Rudolph database. Readings can be retrieved from the database and viewed or printed at any time. The data base is backed up to an external source (USB or network) at whatever frequency the user sets. A SECOND copy of the date can also be saved either to the internal drive, to USB or to a network location using formats compatible with adobe, excel, SAP and most LIMS systems. This mode is considered unsecure because no operator details are required or saved with the data. This mode is provided as standard with every instrument and is the easiest to use and most versatile. It does NOT comply with US FSA regulation 21 CFR part 11.
Embedded – Secure
This mode was designed to comply with the requirements of US FDA 21 CFR 11 and it comes with a certificate showing it has been challenged under those rules. The ability to record both to a data and to a file system is retained. Configurable passwords and an audit trail is added. Many of the features that would allow for result tampering (such as the use of Excel formats) are deliberately blocked in this version.
With these systems the control module of the instrument is disabled and the instrument is operated using the same software but located on an external PC. Operating this way has many disadvantages, it more expensive as a PC is required and it uses more bench space. It is however sometime preferred where a company has a defined network PC configuration and only systems from that manufacturer or in that configuration can be connected to the network.
External – none
While it is theoretically possible for this system to be supplied the application need is extremely limited.
External – Unsecured
This type of system can be useful in a research environment. The use of an external PC means that the instrument can more directly interfaced with math programs. It also finds application in non pharmaceutical applications where corporate IT rules dictate PC type.
External – Secure
This system is designed for pharmaceutical companies where central IT policies dictate the exact configuration of all network computers. This system is also sometimes easier to configure for backup. Since the date goes directly on to the computer hard drive and since the computer hard drive may already be backed up as part of a corporate wide program its one less installation step.