Has anyone who needs to comply with 21CFR11 who uses Agilent/HP 1100 with the hand-held controllers done an assessment of them against 21CFR11? Have you been challenged by the FDA over them? Our IT group have been shaking their heads and frowning since they found we had them - no user logins, data can be overwritten and there's no permanent record of it (the system logbook resets if you switch the system off!), no record of what the system actually did, etc.

We are going to upgrade to instrument control from a CDS, but this is after our upcoming FDA audit, so we need something in place before then.

First, write down an action plan where you specify that you will upgrade your systems to a compliant CDS at a given date (no matter if it is after the audit).
Second : the hand-held controller is used just for instrument set-up and monitoring, not for chromatogram collection and processing, so you must have another system for this. Assess this system and make sure you have procedural work-around to fill the gaps you will find.

I agree with Beppe, I would concentrate on a gap analysis and its related action plan.

The crux of the problem with unifying on a common data system is that is usually requires using the analog output of the detector and this breaks the link between the data and the instrument conditions at the time of data collection.

As an interim solution you can connect and configure cheap inkjet printers to each system and procedurally require analysts to print the method, system, and sequence logbook following each sequence.

In the longer term you are going to have to think about how you are going to insure the integrity of the data that you collect. ChemStation for example collects the binary encoded GLPsave register that links the raw data to the acquisition method to the instrument parameters at the time of data collection. I would argue that any compliant solution is going to require these features, this probably means ChemStation. Now you will be in the unfortunate situation of validating one software package to control your instrument and another to process your data.

I like the modern chromatography data systems I just think you need to be careful about implementation with modern hardware. My recommendation would be to not kludge together a system that trades all meta data and instrument control for common data processing.

www.labcompliance.com may be a useful resource.

Good Luck.

In our full GMP lab with many HP1100 standalone "game boy" units, we require the analysts to document (prior to sequence initiation) all the HPLC instrument parameters (notebook or controlled worksheet). We have a CDS attached only to the analog output. The CDS data files have a notation linking to that notebook page. Of course, this assumes the same HPLC system method was used throughout the sequence (constant instrument control).