by - OBJECTIVE:
To lay down a procedure for System Policies, Access Control and Electronic Data File Path Management for Analytical Instrument Software.
- SCOPE:
This SOP is applicable for maintenance of system and user policy, user Name, ID, Password, privilege & electronic data path management for HPLC,UV, GC& FTIR Instrument software’s in Quality Control Department.
RESPONSIBILITY:
Officer / Executive QC/ IT-Administrator
- ACCOUNTABILITY:
Quality Control manager
- PROCEDURE:
- SOFTWARE USER POLICY FOR USER NAME, ID, PASSWORD & PRIVILEGE FOR
HPLC, UV, GC& FTIR INSTRUMENT SOFTWARE:
- All software’s activity shall be controlled with audit trail or manually (in which audits trial facility not available).
- Only Authorized person should be used the mentioned instrument and its software with below mention privileges(For HPLC):
| Privileges | IT-Administrator | QC Administrator | Supervisor/ Reviewer | Analyst |
| Creates Users | No | Yes | No | No |
| Project Creation | No | Yes | Yes | No |
| Configure Instrument System | No | Yes | No | No |
| Privileges Allotment | No | Yes | No | No |
| Backup | Yes | No | No | No |
| Restore | Yes | Yes | No | No |
| Method Creation** | No | No | Yes | No |
| Method Modification** | No | No | Yes | No |
| Sequence Creation and Modification (Prior to run) | No | No | Yes | Yes |
| Raw Data processing and Print | No | No | Yes | Yes |
| Reprocessing** | No | No | Yes | No |
| Delete audit trial and data | No | No | No | No |
| Delete sequences | No | No | No | No |
| Create & Updating of Project/File/Path** | No | Yes | Yes | Yes |
- Following are the Privileges assigned as per levels: **
Note:
** The above privileges shall not be limited to specific software
- Only Authorized person should be used the mentioned instrument and its software with below mention privileges(For UV, FTIR, GC):
- Following are the Privileges assigned as per levels: **
| Privileges | IT-Administrator | QC Administrator | Supervisor/ Reviewer | Analyst |
| Creates Users | No | Yes | No | No |
| Project Creation | No | Yes | Yes | No |
| Configure Instrument System | No | Yes | No | No |
| Privileges Allotment | No | Yes | No | No |
| Backup | Yes | No | No | No |
| Restore | Yes | Yes | No | No |
| Method Creation** | No | No | Yes | Yes |
| Method Modification** | No | No | Yes | No |
| Sequence Creation and Modification (Prior to run) | No | No | Yes | Yes |
| Raw Data processing and Print | No | No | Yes | Yes |
| Reprocessing** | No | No | Yes | No |
| Delete audit trial and data | No | No | No | No |
| Delete sequences | No | No | No | No |
| Create & Updating of Project/File/Path** | No | Yes | Yes | Yes |
Note:
** The above privileges shall not be limited to specific software
- Users should be qualified for respective instrument operation and Analysis activity.
- Users should be well aware to his/her privileges.
- The
privilege of delete the audit trial files and sequence files shall not provide
to anyone.
- For mentioned instruments, where software is dedicated to the instrument, three levels of user to be defined.
- FOR THREE TYPES OF ‘USERS’ ARE DEFINED BELOW:
Administrator (IT & QC Administrator)
Supervisor/Reviewer
Analyst
- ACCESS TO COMPUTERIZED LABORATORY INSTRUMENTS:
- The Manager QC/Designee shall ensure that logical access to the computerized laboratory instruments, being used in the Laboratory, is restricted to authorized personnel only.
- Each instrument user shall be assigned user identification code/Name and password for accessing the mentioned instruments during routine analysis. This shall ensure authenticity, integrity and confidentiality of the laboratory records generated by a mentioned instruments user.
- The IT and administrator shall be granted to access/authorization.
- Each user perform the analysis activity on mentioned instruments in a specific user ID which assigned by individual name or other unique number.
- The user name mention in “List of Authorized Person for uses of Instrument & Software”.
- New user shall raise the request, Titled “Requisition for User ID Creation/Deactivation” and same shall be approved by Manager QC/Designee, submit it to the administrator for assigning user ID with password by IT administrator.
- The user ID shall be disabling by IT and administrator after approval of Manager QC/Designee if the user left the organization.
- The user ID and password shall be granted to a user after ascertaining that the user has adequate training/experience to generate and maintain the electronic records.
- The user access rights and privileges for various functions shall be configured by the administrator in the laboratory workstations, based on the functions availability in the software.
- Any outside service engineer and analyst can operate the software by using the Guest user ID and there password protected by IT administrator.
- USER RESPONSIBILITIES:
- IT and administrator shall be responsible for creation of monthly projects.
- After logging in for the first time in a workstation, each user shall change the generic password given by the administrator, in order to maintain the secrecy of his password.
- Each user shall be accountable and responsible for actions initiated under his password usage.
- Each user must lock/logoff the computer before leaving the workstation. Or else, the computer will automatically get locked after about 5 minutes.
- User has to change the password at the time when ever required.
- Each user shall provide proper justification for any changes made in software for audit trial.
- Audits trial/ electronic data folder shall be checked on periodically on every Monthly by Lab QC supervisor with help of IT and administrator and filled the observation Titled “Checklist for Verification of Audits Trial & Electronic data folder”.
- A user shall not disclosed his/her password to any other user at any point of time in order to maintain the authenticity, confidentiality and integrity of data generated under his password usage and to avoid any falsification of records.
- Audits trial/ electronic data folder of each sequence shall be reviewed by QC supervisor/reviewer.
- INSTRUMENT USER PASSWORD POLICIES:
- Each user password shall be at least 6 characters long, contain both alpha and numeric in order to avoid easy detection of password.
- Each user shall be allowed a maximum of 5 attempts to login into computerized lab instrument. After 5 unsuccessful attempts to log in, the user ID shall be locked automatically.
- The supervisor shall raise the request to the administrator to unlock user ID in case of a user ID locking. The IT administrator unlock user ID or issue a new user ID, after verifying the reason and training.
- For Guest password authority shall be held by QC administrator.
- In case of QC administrator not present in plant, envelop policy shall be fallow i.e. password kept in an envelope and same shall be kept lock & key by Head QA.
- USER ACCOUNTS MANAGEMENT:
- A record of user name and user ID of the analytical systems shall be maintained.
- This record shall be maintained by Q C administrator for controlling the system access.
- The QC administrator shall review the user record regularly to deletion/disable of obsolete users or to change the profile of user as his/her role changes.
- If any abnormality observed with respect to electronic data it shall be bring into the notice of Manager QC/Designee. Investigation, impact evaluation and suitable action shall be initiated by Manager QC/Designee.
- ELECTRONIC DATA CONTROL :
- Electronic data should be stored as pre specified data path or folder.
- File, Folder and Data path should be prepared by QC administrator login.
- Analyst should be stored the data in pre specified File, Folder and Data path.
- File, Folder and Data path details as below mention:
- All electronic data backup shall be taken by IT personnel as per respective SOP.
- Only one month electronic data shall be store in QC.
- FOR HPLC:
- File Name procedure :
Method Name : (D:) _Year_Month_Method Name_ Test Name
Sequence Name :(D:) _Year_HPLCName_Sequence_Month_Date_File Name
- Report Format Name:
- Single : For System suitability parameter, Blank
- RSD : For Standard, Test and BKT.
- For Ultra Violet and Visible Spectrophotometer :
- File Name : (D:)_Product _B.No._Test Name
Example :(D:) _Vitamin A_B.No._ Assay_Disso
- File Path:
For Result Data:
Local Disk (D:) _Year_Month_Date_ProductName_Test Name
Example: Local Disk (D:) _2019_Dec_2019_01-01-2019_Vitamin A_Disso.
- ForFourier Transmittance Infra Red Spectrophotometer :
- File Name :(D:)_IR Data_Year_Moth_Product Name
For Sample :(D:) _IR Data_2019_Jan_2019_Vitamin E
File Path:
For Result Data:
Local Disk (D:) _IR DATA_Month_ProductName_
Example : Local Disk (D:) _IR DATA \NOV-2019_
- ForGas Chromatography :
- File Name/Result Data Set
Example :( E:) _2019_Jan_2019_FlexSeed _Date
File Path:
For Result Data:
Local Disk (E:) _2019_Jan_2019_FlexSeed_Date
- TRAINING:
Trainer : Manager – Quality Control
Trainees : Staff of the QC departments
- DISTRIBUTION:
Master Copy : QA Department
Controlled Copy : QC Department
Display Copy : QC Department
- ATTACHMENT(S):
| Sr. No. | Title | Format No. |
| 01. | NA | NA |
- REFRENCE: In House
10.0 ABBREVIATIONS:
| Abbreviations | Extended Form |
| SOP | Standard Operating Procedure |
| No. | Number |
| Ltd. | Limited |
| QA | Quality Assurance |
| QC | Quality Control |
| IT | Information Technology |
| ID | Identity |
| HPLC | High performance liquid chromatography |
| FTIR | Fourier Transform Infrared Spectrophotometer. |
| UV | Ultra Violet Visible Spectrophotometer |
| GC | Gas Chromatography |
11.0 REVISION HISOTRY OF CHANGE
| Sr. No. | Date | Revision Details | Revision No. |
