Inspection of Audit Trail for chromatography data.

[zlb215]

Dear all;
I used a Agilent Chemstation with a function of GLP.Can it replace Audit Trail? I have no idea about requirement of cGMP inspection related to this question. My manager tell me that electronical record could be repalced by printed chromatography reports, so Electronic Signature and Audit Trail can be avoided.
Best regards!
Terry Z

[Bruce Hamilton]

Unless something amazing has happened to Chemstation, it may not comply with CFR Part 11 requirements. The data can be manipulated and/or deleted without record/traceability - which is a very big no-no..

The GLP function were present in my older versions, but only to enhance reported information for some industries, and by themselves were insufficient to ensure compliance with Pharmaceutical industry requirements.

You really need to talk to your local Agilent people, as they will identify what is required to provide cGxP compliance for the industry you are in. Be prepared to spend some money.

Bruce Hamilton

[zlb215]

Dear Bruce;
I have given Agilent Engineer a phone call earlier.He have not a clearly idea about cGMP and CFR. He just told me whether the audit trail function has been turned on or not may be not included in FDA's GMP inspections.
How do you ensure your hplc sysytem and data compliance with cGMP's requirements,if the GLP function is insufficient? There is not a LIMS in my company.
Best regards!
Terry Z

[krickos]

Hi

Generally I would say that you need to make a declaration and document/sign it off, how you use your software, typically there would be 3 main approaches:

1. NOT using ER/ES, only method/instrument/raw data etc printouts that are signed/checked are considered raw data covered by SOPs/routines/instructions. Old data may not be reused. Typically old data on PCs are periodiclly removed (some dump on server daily).

2. Hybride system typical ER is used but not ES. Fulll audit trail on methods, parameters, data etc but print outs are still signed/checked.

3. Full ER/ES no signatures on paper.

For chemstation: Unless I have missed something, you still need the Chemstore module to obtain full ER/ES capability.

There might be other technical solutions where chemstation data is dump over into another server and software.

[Bruce Hamilton]

As Krickos notes, Chemstore can be added to help build compliance.
The C/S version of Chemstore was much more robust than the standalone, as it was built around an Oracle database.

You don't need a LIMS, you just need the instruments to be networked, and have Windows server. HP sell some relatively cheap ones.,

However, it may be cheaper to just purchase Ezchrom Elite to replace Chemstation, as the reporting options in Chemstore are somwhat restricted, and Ezchrom offers some more flexibility.

If you local Agilent person is unfamiliar with cGxP, then start at Ludwig Huber's site, www.labcompliance.com , as he is the Agilent expert on FDA requirements.

I would be very wary of trying to make Chemstation compliant without ading a known skin, such as Chemstore. Use of Chemstation plus a paper trail system would be a huge red flag for any auditor, and they would start digging very intensively.

You may have to educate, or shoot, your manager. Effective Compliance is never cheap. Perform a needs assessment, and select your hardware and software based on that. When you prepare a User Requirement Specification and send out for quotes , you will be able to work out how much the upgrade will cost - have smelling salts handy..

Please keep having fun,

Bruce Hamilton

[zlb215]

Hi,krickos;
Our situation is similar to the first approach, I think.But there is something different: we never delete any data.Will it be accepted?
Aother question:what is ER's meaning?I think Chemstation will make a electronic record automatically.I am confused.
Best regards!
Terry Z

[krickos]

Hi,krickos;
Our situation is similar to the first approach, I think.But there is something different: we never delete any data.Will it be accepted?
Aother question:what is ER's meaning?I think Chemstation will make a electronic record automatically.I am confused.
Best regards!
Terry Z

Hi

Sorry for using short version of words: ER=electronic record (data, methods, sequences etc) ES=Electronic Signature.

Well the issue an auditor might have with with old data remaining easily accesble is HOW do you make sure that the users does not reuse old data? I am not an ER/ES/part 11 expert so it might not be an issue if you solve with good SOPs, but as mentioned before it is not uncommon under approach one that old data is periodicly moved to limit acess.


Bruce gave some good suggestion and I agree that your manager need to be involved (you two might consider a good course on the topic later on?).

Also I would strongly recommend to spend some time on how to solve/decide how you want to do with this and not rush away and tangle yourselves into something complicated and perhaps divide it up a short time solution and a long term project.

Currently I am myself stuck with the chemstation/chemstore solution (ER only) for GC and CE similar to approach 2 above. Our solution works but is not ideal (we have a chemstore server and chemstation on each client).

Our LCs runs with a Millenium/empower server solution (ER only), one thing for example that is easier here is to review old data compared to the chemstore search option. Sat down yesterday and looked at old LC data back to 2003 with a collegue, very easy.

EDIT:
Chemstation saving electronic records:
Well sure, methods sequences, data etc are saved on PC but not protected from deletion or with versions or audit trail (example: changed integration of peaks).
In the run time check list you have the "save GLP data" tick box, sure a lot of data is saved with each data file, but it does not provide ER/ES compliance. Also each data file becomes HUGE so I would not recommend turning it on "just in case".
In some earlier chemstation version there where also a "save method with data" tick box, it was good (no huge files) at that time but as above no help ER/ES wise.

[zlb215]

Hi,krickos;
I still have some questions:
1.Can all three approachs provide audit compliance?
2.About approach 2 above, I want to know something more clearly about how to make "Fulll audit trail on methods, parameters, data etc " by this approach.
3.I uesd Empower/Empower 2 in the past, as you know, there is a "audit trail" function in the software,can problem be solved just by pressing the "audit trail" button?Or need something to complement?
Thank you for your instruction.
Best regards!
Terry Z

[JGK]

Empower 2 is made GxP compliant and ER/ES usage is set by setting the systems polices correctly. the systems policies also set security levels for file manipulation.

These in association with user access levels and rights permissions make the software compliant.

If you have been operating a system where the raw data is not protected (can be altered or deleted without a record of who performed the action), then you must have:

A clear definition of what is regarded as the "raw data".
SOPs covering the operation of the system in a manner determined to satisfy compliance.

The last time I used a "semi" compliant system (it only had partial audit trails and raw data security was an issue, no proper ES), we:

Defined the printouts (sequence, Method, results and chromatograms) as the raw data;
Any reprocessed chromatography was placed in the data next to the original;
SOPs were in place covering, operation, maintenance and testing of the software as well as the retention, maintenance and archiving of electronic data files.

[Jackus]

...
The last time I used a "semi" compliant system (it only had partial audit trails and raw data security was an issue, no proper ES), we:

Defined the printouts (sequence, Method, results and chromatograms) as the raw data;
Any reprocessed chromatography was placed in the data next to the original;
SOPs were in place covering, operation, maintenance and testing of the software as well as the retention, maintenance and archiving of electronic data files.

We used your approach in our GLP lab too but it is supposed for meantime when we switch to EZChrom Elite C/S.
This approach is accepted by auditors for the present.