Hi,

Has anyone purchased or taken a good look at the Cerity CDS. I need a CDS for a pharmaceutical stability lab and I like the Agilent 1100s.

Regards,

Steve

Steve

I have just installed and qualified a Cerity standalone (for the moment) system with a 1100.
My first feelings are good, software and qualification are globally OK.
Everything for part 11 compliance is there, and even more in a seamless package.
Early Maintenance Feedback has not been developped yet and diagnosis is very reduced compared to ChemStation, but I hope this will come.
Archival functionalities seem to have improved (vs ChemStore) but backup functionalities (or at least recommendations for backup strategy) are still not included.
For a standalone system, by a big big PC; for a networked system, follow Agilent recommendations to separate hardware components.

Steve,

I haven't taken a good look, but I have poked around a little. The system seems functional as far as instrument control and data analysis. I'll refer you to the marketing material for the good points. Here are some of the limitations I saw:
1) No macro language or publicly exposed API
2) No way to export data or effect LIMS or ERP integration
3) Data approval has to occur on a different screen than data review making "batch approval" very cumbersome.
4) User authentication and e-sig both tied to DNS authentication and not configurable.
5) As Beppe mentioned no EMF, diagnostics, or instrument OQ/PV
6) I don't like the way all data sturctures are objects and stored in the database as BLOBs. This prevents me from being able to query my data and integrate with other systems. Current system is a hybrid with some objects being stored in the file system and some in the database. However I understand that with the next release all objects will be in the database.

I think the last point is the most important. I'm possessive about my data and don't like vendors to lock it away so I can't read it. Security and audit trails are good, inaccessibility and obscurity are bad.
If you are sold on the 1100s I think I would wait for the next major release of Cerity and the 32bit version of ChemStation then do a comparison.

Beppe,

As far as I know, none of the CDS vendors include any type of database backup and recovery or disaster recovery in any of their "qualifications". Take a look at recommended backup strategies on www.technet.oracle.com. Oracle is a large and complex application that takes considerable hardware to ensure the durability of all transactions. However, all CDS vendors want to make the entry point for their software lower so they gloss over what it takes to run Oracle reliably. Plus, every dollar spent on hardware is one dollar less for software licenses.

18 months ago we installed Agilent Technologies ChemStore (B.01.03 + A.08.03) across 2 labs on one manufacturing site in the UK. Its generally a good product and meets most 21CFR11 requirements (as assessed by my companies assessment procedure). Lack of recommended backup and disaster recovery procedures has been a problem. Although we have implemented and validated our own procedures, I am currently working with Agilent to agree a disaster recovery contract which entails them developing, validating and periodically testing several disaster recovery scenarios (i.e. database corruption, total loss of server etc). I must admit to being very disappointed with Agilents lack of ownership in supporting us with this issue right from the beginning of the installation. As an example, the Oracle DB was left in archive log mode - off. So not only did they not provide a backup solution but they left the DB in a state that would not allow hot backups which was one of our user requirements. Fortunately we had sufficient Oracle expertise to resolve this problem - I`m sure not everybody has this expertise, and as a result, are probably not in compliance as regards regular backups.

I understand from other colleagues, that the situation is no better with Waters and other vendors but I cannot confirm that.

Come on vendors - get your act together. You cannot expect to sell and install products like this to GxP companies and not provide a full backup service.

If anyone is interested in forming a discussion group on in-line or laboratory computer and equipment validation in the UK please contact me at the e-mail address below:-

UKdiscussiongroup@hotmail.com

Perhaps we can bring some more pressure to bear on the likes of Agilent, Waters, Perkin Elmer, Metrohm, Foss, Sievers, Microtrac, Coulter, Beckman etc etc etc.

Steve, Tom and Anon (who, I guess, I know),

A few precisions about Tom comments :
1) This is a CDS specially devoted to Pharm, so it is normal, for regulatory reasons, that maco commands are not there (too difficult to keep a good validation status); however there is a built-in custom calculator that enables automating special calculations, one of the things people used to need macro for.
2) there are some provisions to link the system to a LIMS (I have not explored them yet).
4) Although users are managed through OS console, user profiles are totally configurable (one can even create and store generic custom profiles - not possible with ChemStore)
5) EMF is absent, a few diagnosis functions are present, OQ/PV is present and fully efficient (not visible in software menus because it is a "separate" application - accessible only to specific users)