sop for Password for Analytical Instrument and LIMS software

1.0. OBJECTIVE

1.1 To lay down a procedure for the usage of passwords to ensure protection of the raw analytical data generated by HPLC , other instrument software’s and LIMS (laboratory information management system) software in Quality Control department during working.

2.0. SCOPE

2.1 This SOP is applicable to HPLC instrument PCs and their software, other instrument software and LIMS software used in Quality Control Department

3.0. RESPONSIBILITY

3.1 Analyst shall be responsible to use the passwords during the working in the laboratory.
3.2 Computer Operator shall be responsible to use password during working in LIMS software.
3.3 Asst .Manager/ Manager-QC to be responsible for verification to facilitate selection and usage of passwords by the analyst and computer operators.
3.4 AGM-QC to ensure compliance of this SOP.

4.0. ACCOUNTABILITY

QC Head

5.0. PROCEDURE

5.1 Any analytical data generated in Quality Control must be protected so that under any circumstances it will not get lost or modified or altered by accident or by purpose.
5.2 This protection is to be given through usage of Passwords.
5.3 All the persons working in Quality Control shall ensure that wherever possible the soft copies generated during the analysis shall be protected by usage of passwords.
5.4 The soft copies of Data files generated through Analytical instruments shall be retained in the
laboratory computers and protected through passwords.
5.5 The following analytical instruments and software programs available in the Quality Control Laboratory shall be provided access control through passwords.

5.6 HPLC Shimadzu:

5.6.1 Head section shall instruct the chemist to have the access to the analytical instrument.

5.6.2 The password handling shall be done in the following manner.
5.6.3 Every person of the laboratory shall ensure the secrecy of his own password.
5.6.4 A Format, Annex-I shall be maintained in the laboratory. In this format, under the name of the specific instrument or software program, the names of the laboratory people who have been assigned password access for it will be mentioned.
5.6.5 Section head shall collect the password individually from chemist and fill the detail as per Annex-I of this SOP and finally handover Annex-I to Head QC.
5.6.6 Head QC shall keep password as per Annex-I in lock & key to maintain secrecy of the password.
5.6.7 The moment if it is suspect that secrecy of a password has been disturbed, a new password shall be implemented by the users or Managers and record shall be maintained as per Annex-I of this SOP.
5.6.8 At any time, head QC shall ensure that he has the record of all passwords which are used in his laboratory.
5.6.9 In case if analyst, who is using passwords, left the company, within next 15 days, his name shall be struck out from the list.
5.6.10 During the working, if any analyst come across any practical difficulty, he/she shall contact the senior or service engineer of the instrument.
5.6.11 For practical purposes to access some of the common software or PCs the QC personnel may need to use some common passwords. In such cases the secrecy of passwords shall be strictly maintained within the QC department.

5.7 SELECTION OF PASSWORDS :

5.7.1 The password shall be of 5 to 8 characters.
5.7.2 The passwords shall be alpha-numeric.
e.g. * sam562120

5.8 CHANGING OF PASSWORDS

5.8.1 All the passwords shall be changed once in six months, e.g. analyst who has initiated password usage in the month of Jan 2020 have to change it by July 2020
5.8.2 One analyst shall not use the same password in more than two instruments.
5.8.3 The same password shall not be used for the next five cycles.

5.9 Do’s of Passwords
5.9.1 Use the password of 5 to 8, alphanumeric characters.
5.9.2 Change the password after every 6 months.
5.9.3 Disclose the password only to head QC as per procedure.
5.9.4 Change the password, the moment if it is suspected that it has lost its secrecy.

5.10 Don’ts of Passwords
5.10.1 Never disclose password, except once to the head QC.
5.10.2 Do not use the same password in more than two instruments.
5.10.3 Do not use the same password in 6 cycles at a stretch.
5.10.4 Ensure to remember your passwords.

5.11 User’s access control (Use access rights) :

5.11.1 Depending upon the nature and software of the instrument, head QC shall ensure that different levels of users shall have different rights of access to the software usage. This is also called as Privileges.

5.11.2 Levels of Privileges for Shimadzu HPLC.
USER : Analyst shall use testing method in the HPLC but there is no rights to change testing method.
SUPERVISOR : Section Head shall be prepare method of analysis in the software.
ADMINISTRATOR : Admin person shall be check the audit trials in the software.

5.11.3 Levels of Privileges for LIMS software.
USER : Analyst and computer operator shall be use LIMS software for entry of result and generation of COA and Labels .
REVIEWER : Asst. Manager/Manager shall be review the result entered in the software .
ADMINISTRATION : Admin person shall be responsible for review and editing.

5.12 Levels of Privileges for Shimadzu HPLC
5.13 Shimadzu LC Solution software system :

5.13.1 The user must login as unique User Id.
5.13.2 The user must login by unique user password.
5.13.3 The password of the each individual user must be change after 180 days.
5.13.4 The minimum password length must be 5 to 8 alphanumeric characters.
5.13.5 The limit for false password attempt is 03 tries.
5.13.6 Don’t allow the applications to stay running after logging off.
5.13.7 Don’t allow multiple logins.

5.14 Procedure for creation of New user :

5.14.1 Double click on LC-Solution.
5.14.2 Click on Data base.
5.14.3 Login ID and Password (Administrator Logon to the LCsolution software).
5.14.4 Go to Tools and select “user Administration”.
5.14.5 Click New or Edit option.
5.14.6 To create or edit users, set permission group for operator, reviewer etc…

5.14.7 Select the appropriate user instruments available.
5.14.8 Select password check box and provide password.
5.14.9 The set password of new user must be changed by user at the time of first login.

5.15. User account policies:
5.15.1 Administrator shall creates user by following step no. 5.14

5.16 In the user account policies following settings are defined;
5.16.1 Audit trail option must keep on at the time of creating method file.
5.16.2 Editing the method parameters is prohibited.

5.17 Following settings are defined for File management.
5.17.1 Overwriting of the data file is prohibited.
5.17.2 Overwriting of the other method file is prohibited.
5.17.3 Overwriting of report file is prohibited.
5.17.4 Overwriting of batch file is prohibited.

5.18 Procedure for modification of User account;
5.18.1 Login to the LC solution software with administrator rights and change the user rights or
modify the user account and click OK.
5.19 The privileges of the individual users are given based on the rights given to them.
The list of privileges is defined as per Annex-I.

6.0. ABBREVIATION :

Sr. No.	Abbreviation used	Full form of abbreviation used
1.0	QC	Quality Control
2.0	QA	Quality Assurance
3.0	SOP	Standard Operating Procedure
4.0	NA	Not Applicable
5.0	Sr.	Senior
6.0	GM	General Manager
7.0	AGM	Assistant General Manager
8.0	Asst	Assistant