Follow
1.0 OBJECTIVE
To lay down a procedure for operation and management of LabSolution software that includes access control, privileges, creating, naming and usage of projects, methods, sample sets, audit trail review investigation and backup of data.
2.0 SCOPE
This procedure is applicable to LabSolution software that is connected to Shimadzu HPLC, IR and GC of QC (Company Name), Shimadzu HPLC, GC and IR of QC (Company Name), Shimadzu GC of QC (Sterile). This procedure is also partially applicable for Shimadzu TOC, UV, AAS of QC (Company Name), Shimadzu UV of QC (Company Name) and Shimadzu TOC, Bruker IR and Thermo UV of QC (Sterile) of (Company Name) which is also connected to LabSolution software through class agent software.
3.0 RESPONSIBILITY
3.1 All users (the responsibility at different user level shall be maintained as mentioned in the users privilege limit).
3.2 User having privilege of supervisor or Manager are responsible for Project creation and backup of the data.
3.3 Administrator will be responsible to take data backup in the server, maintenance, safety and overall security of the software.
3.4 Supervisor / Manager shall be responsible for storage of the CD/DVD’s containing the back-up data with register.
3.5 Manager shall be responsible to run the backup into the CD or DVDs
3.6 Overall responsibility for training, implementation and compliance with the QC Manager or his/her nominee.
4.0 ACCOUNTABILITY
4.1 Head of Quality.
5.0 PRECAUTIONS
5.1 Make sure that the Separation Module, Detector, PC and the Printer are connected to power supply.
5.2 Make sure that right user ID and Password is given before logging attempt.
5.3 Before commencing any analysis make sure that the project audit trail is activated.
5.4 Before delete any project ensure that proper backup of the project is taken.
6.0 PROCEDURE
6.1 Reference and Definition
6.1.1 Refer SOP QC201 for operation and qualification of Shimadzu HPLC Systems.
6.1.2 Refer SOP QC038 for operation, cleaning and calibration of UV-Visible Spectrophotometer.
6.1.3 Refer SOP QC040 for operation and calibration of TOC Analyzer.
6.1.4 Refer SOP QC037 for operation, function check, cleaning and calibration of FTIR Spectrophotometer.
6.1.5 Refer SOP QC039 for operation and calibration of Atomic Absorption spectrophotometer.
6.1.6 Definition
• Administrator – MIS Manager or his/ her nominee is the administrator for Labsolution Software.
• System Administrator – QA manager or his/ her nominee and service engineer is the system administrator for Labsolution Software.
• Manager – Manager QC or his/ her nominee is the manager for Labsolution Software.
• Supervisor – Functional group leader, senior analyst or nominated persons of QC manager.
• Analyst – Assigned persons of Quality Control department.
6.2 Operation is divided into four groups based on functionality
• MIS – For Management Information System.
• QCS – For Quality control Department sterile facility
• Track-I – For Quality Control department of Track-I
• Track-II – For Quality Control department of Track-II
This is for control over data and / or functionality.
6.3 Classification of LabSolution user types/group
• System Administrator – Quality Assurance Manager or His/ Her nominee and Service engineer.
• Administrator – MIS Manager or His/ Her nominee.
• Manager – Manager QC or his/ her nominee.
• Supervisor – Functional group leader, senior analyst or nominated persons of QC nominated by QC manager.
• Analyst – Assigned persons of Quality Control department.
The privileges of the above user types are given in Annexure-I. List of the authorized users of above user’s type/ groups are to be mentioned in Annexure-III (Master list of authorized users which shall be updated half yearly or when required).
6.4 User ID and Password Controls
6.4.1 All users shall use individual ID and password.
6.4.2 Creation and deletion of User ID shall be initiated by Manager or his/ her designee through a request format as given in Annexure – II.
6.4.3 Manager shall send the approved request form to administrator. Administrator is responsible for creating user ID.
6.4.4 To create new user, log on to labSolution. LabSolution main window will appear. Select administrator tab (Third icon of left column) if automatically not selected.
6.4.5 A set of icons will appear at the top of the screen. Select ‘User Administration’ icon. Another set of icon appears. Double click on ‘User Administration’ icon.
6.4.6 Click on ‘Add’ icon, pop up screen will appear. Give following information:
• User ID
• User Name
• Password
6.4.7 At the bottom of the pop up screen, select ‘right group’ and ‘user group’ which user belongs to. Finally click Ok.
6.4.8 Create passwords of not less than 6 characters.
6.4.9 User ID for LabSolution shall be a combination of user code (alpha numeric) and employee code (numeric). Example: If a user code is abc (which is the official user ID) and employee code is 1234, user ID shall be ‘abc1234’.
6.4.10 Password complexity mood is activated. So password must have at least three different characters. Example: (Company Dox).
6.4.11 Do not use easily identifiable passwords like initials, names of children, date of birth or nick names.
6.4.12 After completion of creation of an ID, manager shall allot User ID to all users in QC group with an authorization letter (format as given in Annexure – IV) which will be preserved in QC.
6.4.13 Password shall be changed once in every 90 days.
6.4.14 Maximum number of trail of a password will be 3.
6.4.15 Password sharing is strictly prohibited.
6.5 Creating and Naming the Projects
6.5.1 Supervisor or manager shall be responsible to create and naming the project.
6.5.2 Log in according to defined privilege. LabSolution main window will be opened.
6.5.3 Select administrator tab (Third icon of left column) if automatically not selected. A set of icons will appear top of the screen. Select ‘Project Administration’ icon.
6.5.4 A new window will appear. Click on ‘Add’. Project creation wizard will appear.
6.5.5 Allot ‘Project Name’ by following the procedure given below and give comments in the relevant field.
6.5.6 Enable ‘Copy from other project’ and select desired field, method, template etc. which required copying to new project.
6.5.7 Click on ‘Next’. Again click on ‘Next’. Select desired instrument for which this project is applicable for. Finally click on ‘finished’.
6.5.8 Again select newly created project. Click on ‘edit’ and then ‘security policy’. Select ‘Instrument Tab’ and from drop down list select desired instrument type (e.g. LC, IR, GC).
6.5.9 Disable ‘Prohibit opening a file in each item’ and then ‘ok’.
6.5.10 This procedure is applicable for HPLC, GC and IR. For UV, TOC, AAS, a default project is created during installation and continue.
6.5.11 Projects shall be created for every month at the end of the previous month (only HPLC, GC and IR). The naming of projects shall be done as explained below.
6.5.12 Project Name shall be Alfa numaric. First 2 characters shall indicate the department.
6.5.13 Then ‘_’ (Underscore).
6.5.14 Next characters shall indicate the Instrument ID.
6.5.15 Then again ‘_’ (Underscore).
6.5.16 Then month consisting of the first three characters and year of four characters.
6.5.17 For Example. : For the month of January 2014 for Equipment ID QC/207 the project name shall be QC _207 _JAN2014. In some cases, with permission of manager project name can be named as per product name or generic name of the product.
6.5.18 For TOC, UV and AAS, project naming procedure will be as follows.
6.5.19 Project Name shall be Alfa numaric. First 2 characters shall indicate the department, next one (-) dash, next characters shall indicate the Instrument ID. Then space and finally instrument type.
6.5.20 For example: For UV, Equipment ID QC/003 the project name shall be QC-003 UV.
6.5.21 For Method Validation, there will be parent project name ‘Analytical Method Validation’ under ‘project’. New project will be created under method validation as sub project and the name will be as per their material name or generic name of the product (e.g: Paracetamol Tablet USP, Paracetamol USP or BP).
6.5.22 There will be some dedicated Project for specific work viz. ‘Analytical Method Development’, ‘Analytical method Transfer’, ‘Process validation’, ‘Comparative study’ and ‘HPLC Column Calibration’.
6.5.23 Administrator or his/her nominee shall delete the projects older than three months after the backup is completed by MIS department.
6.6 Assigning name for the instrument methods
6.6.1 Instrument method Name shall have at least Instrument name, product name and test name for HPLC, IR and GC methods.
6.6.2 Instrument method name shall be given on the basis of Instrument brand name (for HPLC S for Shimadzu and for GC, brand name shall be GC,), detector type (PDA, UV or RID, for GC detector type is not required), product or material name/abbreviation, and test initials (for GC test initials is not required) and if any special information. Special information shall be continuation if required. If full name of the material is not possible use first four letters and element name (if presence).
6.6.3 For Example: Using instrument Shimadzu HPLC with PDA detector, Napa Tablets, Assay Test, Instrument method shall be SPDA_Napa_AS If the material name is pantoprazole sodium sesquihydrate, Instrument method shall be SUV_Pant Na_AS. For GC Instrument method shall be GC_Paracetamol for testing paracetamol.
6.7 Assigning name for the batch table
6.7.1 Sample set name shall be created on the basis of instrument number, product/material code or name and test abbreviation and if any special information (For GC, Instrument ID and Test initials are not required). Special information shall be continuation. At the tail of the name date of the analysis should added but not mandatory.
Example:
1) The batch table created for Assay of Napa tablet shall be named as: QC_207_NAT_AS_050913.
2) The batch table created for Napa tablet method validation shall be named as QC_207 _AMV_NAT_AS
3) For GC batch table shall be GC_Paracetamol or GC_Paracetamol_050913 for testing paracetamol.
6.7.2 Test abbreviation shall have maximum 4 characters only.
6.7.3 A running sample set can be paused to include additional samples.
6.8 Creating and Assigning Name for reporting methods
6.8.1 Creating procedure of reporting format is described in the respective instrument operation SOP
6.8.2 Report formats shall be prepared on the basis of test requirements. Based on the requirement, additional report methods can be created or existing report method can be altered. This alteration or creation of new report method should be done by the analyst with appropriate comment.
6.8.3 Report formats shall be named with test name and with special information and as per the requirement (if any).
6.8.4 For Example: Related substances test report format name shall be named as “RS Report” for test sample, “Assay Report”, for all standards “Standard Report” etc.
6.8.5 Reporting format Header must have at least the following parameters: Method Set Name, Project Name, Acquired by, Run time, processed date, Sample Set Name and Injection volume.
6.8.6 Reporting format “chromatogram legend” must have at least following parameters:
Vial
Injection
Date acquired & Time
6.8.7 Reporting format “Peak Table” should contain parameters as per the individual test requirement.
6.8.8 Reporting format should contain ‘Audit trail’.
6.8.9 Reporting Method Footer must have the following parameters:
– Analyzed by, Checked by & Page no.
6.8.10 Print the results through ‘Postrun processing and reporting’ window.
6.8.11 Instrument method print shall be taken for the first result of sample set.
6.8.12 Method set print shall be taken for the first result of the sample set.
6.9 Audit Trail Comments
6.9.1 If any changes in the parameters of software, Enter audit trail comments based on the changes made.
Example: Peak width changed for base to base integration.
Threshold changed for integrating low responses.
Minimum area changed to avoid noise getting integrated as response.
Integration inhibition changed for not integrating the blank peaks below 3 minutes.
Make appropriate comments for other changes similarly.
6.10 Security policy
6.10.1 Security policy setting is attached in Annexure-V to Annexure-IX
6.11 Backup Procedure
6.11.1 Backup shall be used for backing up all data to a removable media for safe management and archival of data.
6.11.2 With this application Administrator will drop the backup file in Backup folders (C drive in LabSolution server) during daily morning. The created backup in backup folder in the server contains all project data and all log files. From this folder backup shall be taken by using HP data protector express basics 5 software to taps (HP LTO-3). Another copy will be saved in the backup server.
6.11.3 Log in to the LabSolution software with individual user ID and Password.
6.11.4 LabSolution main window will appear. Select administrator tab, a set of icon will appear at the top of the screen.
6.11.5 Double click on ‘Backup’ icon. Select all project, give reason or comments and then click ‘next’.
6.11.6 Select destination folder, unmark all other marked field and then give password and click ‘Next’.
6.11.7 Select ‘print backup information after backup’ and then click on start. A pop up dialogue box appear. Click ‘ok’. Backup will start. It will take several minutes to several hours.
6.11.8 After completion of backup, using HP data protector express software, all data will again be backed up in a data cartridge (LTO-3).
6.11.9 A copy of all backed up data will again past in backup server.
6.11.10 At the end of the month, Administrator will give a copy of all data and log file to a local instrument PC. Manager will write this data to CD or DVD using Nero soft ware as per following procedure.
6.11.10.1 Insert a CD/DVD in to the DVD drive. Click on nero Software icon.
6.11.10.2 Click on add and select project to copy and then click on Burn. After completion of burning click ok to finish.
6.11.10.3 In case of any errors during backup, report to administrator- LabSolution or supplier / designer.
6.11.10.4 After completion of backup in the CD/DVD, name them as DVDN/YYYY, Where N is 1, 2, 3,…… and YYYY means year in four digit. e.g. DVD1/2013. Numbering shall be done during transferring project in to CD/DVDs.
6.11.11 If the transferring of project in the DVD is ok, the same shall be transferred to the archive and kept in designated shelf. Archival details shall be entered in register as per Annexure –X.
6.11.12 After completion of backup, check following parameter to ensure proper backup. If any discrepancy found, discard this DVD and try with new one.
• Total number of folder.
• Total volume (mega bytes/ Giga bytes)
6.12 Project retrieval procedure
6.12.1 Log in to the LabSolution software with individual user ID and Password.
6.12.2 LabSolution main window will appear. Select administrator tab, a set of icon will appear at the top of the screen.
6.12.2 Double click on ‘Restoration’ icon. Select source of restoration, select desire project or all. Click on ‘next’ give password and then start.
6.12.3 Record the restore details in Software’s backup, Archival and Retrieval Register (Annexure – X).
6.12.4 Restore and check any one project from a DVD every six months.
6.12.5 A retrieval trial shall be considered as successful if it does not show any error during retrieval and the total number of file/folder, total volume (megabytes/ gigabytes) of data of parent and retrieved project are same.
6.12.6 If any error is shown during backup or archival, then that backup set shall be tested for proper retrieval before sending to archive.
6.13 Project deletion conditions
6.13.1 A project can only be deleted if no errors are reported in backup, archival or retrieval process.
6.13.2 At any point of time, at least last 3 months projects should be available in the LabSolution software.
6.13.3 Projects should be deleted from the LabSolution server after proper checking of the backup data in DVD/Hard drive.
6.13.4 A project can only be deleted after successful trial of retrieval of any one project from backup set.
6.13.5 A project can only be deleted upon receipt of project deletion request as per Annexure – XI.
6.13.6 The project deletion request shall be authorized by Department Head.
6.13.7 After Approval, the request shall be sent to LabSolution Software Administrator who will execute the deletion.
6.14 Disaster management
6.14.1 All the servers shall be provided with two parallel power supplies from two different UPS power sources to overcome the adverse circumstances.
6.14.2 The server is provided with hard disk drives configured in RAID1 and RAID5 technology. The two hard disks are configured in RAID 1 technology and contain operating system. It is usually a mirroring technique. If one drive fails, the other drive continues to function as a single drive until the failed drive is replaced.
6.14.3 The RAID5 technology and contains application software and data. It is usually a mirroring technique. If one drive fails, the other drives continues to function as a remaining drives until the failed drive is replaced.
6.14.4 The Symantec Backup Exec software provides IDR facility to restore the server software Configuration including OS in case of any server crash.
