ATTACHMENT III Tender No HD Laboratory Information Management System (LIMS)

Transcription

1 Objective: ATTACHMENT III Tender No HD Laboratory Information Management System (LIMS) HPCL Mumbai refinery is looking for LIMS system to automate the Refinery Laboratory operation and manage and quickly share data with user departments. Following are some of the benefits, which must accrue to the Corporation from the LIMS implementation: 1. Improve productivity and unit operational efficiency through timely access to analysis data (real time data) for process management, quality of the processed product, integration with advanced process control, monitoring of performance of units etc. 2. Optimise laboratory costs by optimizing manpower, reducing inventories, improving planning and scheduling and minimizing human intervention. 3. Improve laboratory effectiveness and responsiveness to business requirements by making the lab part of the plant automation solution 4. Streamlines communications between lab and operating personnel and reduces unnecessary work and missed requests 5. Makes analysis data available to concerned through LAN/WAN and through web based browser 6. Automate Lab operations including two-way interfacing of lab instruments 7. Provide seamless integration between LIMS and JD Edward ERP system with bidirectional transfer capabilities. 8. Comply with 21 Code of federal Regulation (CFR) part 11 norms pertaining to electronic signatures and electronic records and supports functions like Audit trail, password management, and User and data security. Page 1 of 8

2 Standard Features: 1. System should be user friendly, fully scalable, flexible and multi location capable. 2. LIMS should include all tools and functions for running across a Local Area Network, a Wide Area Network through the Internet browsers ensuring no installation at the client machines making it a completely web-based system. In case web base system is not feasible in current environment, at least reports and sample recording should be web based. 3. At a given instance of time, system should permit 10 concurrent usage of the LIMS system in the transaction mode and 50 concurrent usage in viewer mode. The extent of access to information for any particular user/viewer shall be based on the level in the organization as decided by HPCL. The system should have in-built features to customize individual tables and menus and to control the access to commands within it on a per user basis. 4. The Enterprise Resource Planning system J.D.Edward is implemented in HPCL Refinery and integration of LIMS with ERP with bi-directional transfer capabilities as per HPCL s requirement is a must. 5. Interfacing to all types of instruments from various manufacturers. 6. LIMS should have capability of OLE for Process Control (OPC) connectivity. 7. The output of the LIMS should be viewable in standard Excel spread sheets as well. 8. Customized reports generated by LIMS can be accessed when queried on various parameters like sample name, time, date etc. 9. Product should be designed and developed under an ISO quality system with the certificate showing the scope. Page 2 of 8

3 10. All requirements should be met with standard functionality wherever possible. If this is not possible, then each requirement should include details any programming required, such programming to be performed using the HPCL IT standard Microsoft.Net language. Page 3 of 8

4 I. SOFTWARE REQUIREMENTS : The project must consists of the following LIMS functional requirement: S.No. Activity Functionality 1. Sample Log-In a. Log-in Sample by field staff and by lab personnel by manual method b. Automatic creation of unique sample ID c. Generation & printing of Bar Code labels d. Quick pick & choose facility for all fields required in registering the sample e. Provision for attachment of special instructions, notes etc. & same to be easily stored and retrieved. f. Auto log-in of schedule samples g. Auto Generation of by originator h. Ad-hoc log in of unknown or emergency samples i. Facility to edit, append & delete (privilege protected) the sample 2. Registration of Samples a. Acceptance of samples in Labs b. Classification of samples c. Auto generation of for acceptance or rejection of sample d. Prioritise samples e. Auto sample distribution based on defined business logic 3. Sample processing a. Allocation of samples by lab officer to analyst & auto generation of Work Sheets b. Viewing status of samples by authorized users (on hold/un-received/received/under test/completed/ unauthorized/cancelled/suspended) c. Modification of samples details by Lab (e.g. Addition/Deletion of tests, Adding more sample details etc) d. Product specification of each sample: Off Spec parameters to be highlighted/window Pop-up/E- Mail/SMS e. Multi level product specifications f. Re analyzing of sample for failing parameters and status change with change in colour/font g. Sample Completion: Auto & Manual h. Sample authorization: Auto & Manual i. Sample retention status/report j. Disposal of Sample k. In-built mathematical computation module as per the defined formulae l. Run time changes of Test result as per defined Page 4 of 8

5 business logic m. Automatic searching of the database to supply historical information about the samples and results 4. Analysis Management a. Track analysis status and report b. Integrated special instruction/ information to be popped up with distinguished notifications / symbol attached to particular sample c. Setting up of temporary analysis and analysis for ad hoc samples d. Prioritize analysis e. Selectable sort sequence for analysis components 5. Scheduling of activities a. Sample generation b. Report distribution 6. Results Acquisition & Validation 7. Reference Data Management a. Manual entry of test data as well as automatic capturing by instrument interface b. In case of auto-capturing test data from instrument, there should be provision to filter and validate the test data by the concerned c. Retain results of ad hoc samples d. Allow numeric and text results e. Results are checked by three levels of limits from the broadest to the most specific & warning limits (limits to be defined by user) f. Alert messages against invalid entries g. Allow Multi level validation h. Manual release of COA on approval of tests or samples (privilege protected) with record of release date & time i. Options for releasing partial filled COA (privilege protected) j. Release of report by . Different master database for a. Test data maintenance including tests, procedures, cost, time b. Storage tank No., Unit tags etc. c. Properties (identifying the results of tests) d. Keyword (for text entry) e. Units of measure f. Calculation expressions / Calculation factors g. Test conditions h. SOP i. Customer database along with their contact details j. Instrument database Page 5 of 8

6 k. Nature of samples l. Test charges, time per test & sample m. Spare parts & consumables n. Chemicals 8. Instrument Management a. Instrument Interface (RS 232/ASCII/Software based) b. Calibration and validation of testing equipment in compliance with NABL (ISO 17025) on a clause by clause basis & GLP environments including internal/external calibration tracking, calibration data storage, alert message when out of calibration. c. AMC & Maintenance details of testing equipment such as service logs, problem reporting etc. d. Instrument spare parts / consumable inventory; alert message when reached to threshold limit 9. Supplies Management a. Total automation of Inventory management b. Generation of Bar Code labels c. Stock receipt with cost d. Stock dispensing with cost e. Inventory Management system with Consumption and Cost Analysis for Chemicals, Spares & consumables, Glass wares & miscellaneous lab items f. Below minimum quantity is to be highlighted / window pop up. g. Facility to view the consumption of Local cash Purchase (LCP) under various heads h. Laboratory Annual Budget facility i. Creation of Purchase Requisition (specification, Part No., Vendor address etc.) in LIMS & then exporting it into JD Edward ERP system j. Categorization of items at every level k. Tracking of expiry of chemicals 10. Personal Management a. Grouping: Authorized levels b. Work Load c. Training details d. Analyst details e. Role level access control of dates f. Monthly Overtime Analysis under various heads 11. Reports/MIS a. COA Certification of Analysis b. Maintenance Report c. Calibration Report d. Stock Control Report e. Analyst Performance Report f. Individual Lab work report of required period Page 6 of 8

7 g. Statistical Quality Control report h. Back log Reports i. Daily summary Report. (15 varieties) & Month End Reports j. In-built report writer for generating and designing reports. 12. Miscellaneous a. On-line help for respective field when cursor is positioned b. A user-definable keyword entry with pop-up prompts for short text result c. Data import facility from external source d. Cost per test / Sample e. Detailed Trend analysis f. Total No. of sample analysed till date g. Total No. of test carried out till date h. Sample Explorer i. BIS/ASTM/IP Methods / SOP j. Sample status viewer k. Calculations/conversion tables l. Density conversion tables m. SQC n. Integrated document management (enabling MS office, Picture, Video, clipping attachment) with version control o. Multilevel filtration of data at any point p. Chain of Custody q. Work plan viewer to monitor the progress / bottleneck with history online r. Attaching external documents to any entity in LIMS so that these attachments will be available within reports. s. Background tasks such as instrument integration, scheduled sample login etc should be achieved using Windows Services. t. Full user functionality of application to be accessed via a web browser. Nothing to be installed locally. 13. Security Management a. Security features on Menu b. Foolproof of audit trail at every level c. Electronic signature compliance. d. Permit only authorized user at each level (password protected) e. Time out facility to block unattended workstations f. Facility to allocate users to group and control access at a group level g. Permit users to access to those functions, which Page 7 of 8

8 they have been granted h. Track & record actions such as entry/modification/deletion of test results, sample details, product specification etc. i. User login should be through ADS password. 14. User friendliness a. User can configure his own screens and how he wants to look at the data b. Create/Modify COA format c. User can modify workflows through a drag and drop interface without help from IT expert 15. LIMS Training a. User level training 80 persons in 4 batches b. Database administration for 4 personnel. c. Operation & Restoration of Instrument interface for 4 personnel. d. Training on report writing tools for 4 personnel. e. Awareness Training to viewer 5 batches of max. 20participants each. 16. Database Software MS SQL 17. Database & Application Server Software should support Windows 2008 and above on Intel based Hardware 18. Client Machines Client should work on Windows XP and above TEM Note1: HPCL shall be providing Server H/W, Client Machines and MS SQL licences Note 2: Bidders have to specify in their technical bid, the required hardware and Software specifications for the following and also what kind of infrastructure support including hardware, software, tools, operating systems, network etc. they expect HPCL to provide them and also the quantity: a. Network b. Client hardware c. Supported operating system for Server and Workstation Note 3: Supply of Instrument Interface software and hardware (including supply junction box, supply and laying of cables used for RS 232C port connectivity to LIMS), Bar code scanner and Bar code label printer are in the job scope of vendor. The quantity of the above items has to be specified in the tender. Page 8 of 8