I’m doing retrospective validation for chromatography data system which is installed in HPLC, the instrument itself (the hplc machine and the detector) already qualified for years and calibrated periodically.
I’m in the process of creating the user requirement specification based on system existing condition (comments are welcome if you have any opinion about this, I’m new in this field ;)).
The system is already installed in the PC (We bought the HPLC bundled with PC), and the vendor only supply the manual book for the instrument only, there is no separate manual book or specification for the CDS itself.
I’m looking for chromatography data system specification (empower 2 waters and lc-solution shimadzu)
Are you looking for Configuration Specification Document or System Design Specification (SDS)? You may ask SDS with the Water’s Vendors. In fact they provide us the Empower manual as well. you may get help from that manual as well.
Elaborate your requirement here, so that I can help you in documenting the same.
First allow me to describe how I retrospectively validate the system, (comments are welcome)
I consider CDS as Category 4 GAMP, configurable software packages, the CDS itself (both empower and lc-solution) is standard software but at least to acquire data it need to be configured with the instrument and environment.
The validation activities is carried on planning phase, design phase, testing phase, usage phase and decommisioning phase (skip the construction and deployment phase, since the instrument and the system has been used for years)
As I previously stated, the system and instrument is already live for years. But the system validation still running in the planning phase
(1) Validation plan already created, and now in the middle of approval process,
(2) I skip the supplier assessment since waters and shimadzu is well known supplier for LC, and it doesn’t make sense to perform supplier audit or asses by now (is it??),
(3) I’m in the progress of URS creation (yes we don’t have URS for the CDS system), the URS is adjustment of existing lab condition and ideal condition from many references. The URS I made is divided into several type:
Environment Power failure Environment Specification
Functional Data Acquisition
Functional Data Calculation
Functional Hardware Interface
Functional Instrument Control
System Alarm and Warning
System Capacity Verification
System Modes of Operation
System Version Verification
Yesterday I visited the lab, to confirm the URS Environment Specification I have made, to check the system information (CPU, RAM, Hard Disk Space) but because the system are installed in many different PC (eg. CPU are varies Intel ® core ™2 Duo, Intel ® Pentium ® Dual CPU, RAM are varies from 496 MB - 1.98 GB). In my personal opinion, it’s not right to use the lowest PC specification standard in the lab as URS for environment specification (since we bought the system bundled with PC). So I need the configuration specification document for Empower pro (Build 1154) not Empower 2 as I previously stated and LC-Solution v.1.20 then I know the minimum requirement needed to install both, the my URS is adjust to it.
Yes, you are right that CDS will fall under Cat-4 (Configurable COTS). Also, I am agree with the phases for SDLC and carrying out validation activities, which is based on the V-Lifecycle for validation. I will recommend here to prepare two separate documents as URS and FRS. The sections which you have mentioned above is mentioning about URS and FRS both. I will suggest you to split FRS in following sections:
Business Activity/functionality Requirements
Business Interface Requirements
Data Input/Output Requirements
Data import/export Requirements
Data Migration requirements
Data Backup/Restore Requirements
Security (Password, User ID, User Role Authorization, Physical Security)Requirements
Othere than this which you have mentioned can be captured in FRS. Are you using Empower application as a standalone system or is on network based on the client server technology? Recently we have moved to Empower 3 and the clients configuration is as below given by waters.
Sorry for my late reply and I believe you must have implemeted the system as well so far. But just for your information I am answering your last question.
FRS can be prepared in conjunction with the vendor and users and OQ test scripts will be having all FRS requirements to be challenged. Instead of creating URS and FRS separately, it is good to prepare UFRS (combined URS and FRS) in a single document.