Local Area Network (LAN) Qualification Guideline

Standard Operating Procedure (SOP) for Local Area Network (IT Network / LAN) qualification procedure, Protocol, and related documentation. Procedure for qualification of IT network equipment’s for the fulfillment of availability of hardware as per requirement, guidance for re-qualification and to provide the procedure for numbering of network equipment.

Qualification of Local Area Network (LAN)

1.0   PURPOSE

    • To provide a procedure for qualification of Local Area Network (LAN) equipment for the fulfillment of availability of hardware as per requirement, guidance for re-qualification, and to provide the procedure for numbering of network equipment.

2.0   SCOPE

    • This SOP is applicable to all relevant network equipment’s i.e. Network switches, rack, LIU, jack panel, cable manager, IO connectors, cables, faceplate, etc. The scope of this SOP is limited to URS, DQ, IQ, OQ, and PQ of local area network (LAN) equipment’s

3.0   RESPONSIBILITY – Local Area Network (LAN) Qualification

    • Information Technology:

    • Preparation and execution of qualification.
    • New Local Area Network (LAN) provision to user and LAN qualification.
    • Maintain the list of equipment.Local Area Network (LAN)
    • Codding of network equipment as per SOP.
    • Layout Updation for Local Area Network (LAN).
    • User Department:

    • To raise the request for new / to modify the Local Area Network (LAN) requirement.
    • Engineering Department:

    • To ensure and verify the utility requirement
    • Coordination with User and IT for new Local Area Network (LAN) requirements.
    • Quality Assurance:

    • Review and approve of qualification documents.

4.0   ABBREVIATION & DEFINITION

IQ : Installation Qualification
IT : Information Technology
LAN : Local Area Network (LAN)
OQ : Operational Qualification
PQ : Performance Qualification
SOP : Standard Operating Procedure
LIU :        Line Interface Unit
    • Qualification :

    • A qualification is an act of planning, carrying out, and recording results on equipment, system, premises, and facilities that form part of the validated process to demonstrate that it will perform as intended.
    • User Requirement Specification (URS):

    • A requirement specification (URS) that describes what the equipment or system is supposed to do, thus containing at least a set of criteria or conditions that have to be met.
    • Design Qualification (DQ):

    • Design Qualification is a documented evidence that the proposed design of the facilities, system, and equipment are suitable for the intended purpose.
    • Installation Qualification (IQ) – Local Area Network (LAN):

    • Activity which establishes that the Systems are properly installed as per approved design specification/manufacturing recommendation and as per requirement.
    • Operational Qualification (OQ) – Local Area Network (LAN):

    • The documented verification that the IT System, as installed or modified, performs as intended throughout the anticipated operating ranges.
    • Performance Qualification (PQ) – Local Area Network (LAN):

    • Performance Qualification is the process of demonstrating that an IT System consistently performs according to the predetermined specification for its intended use.

5.0   PROCEDURE FOR QUALIFICATION OF LOCAL AREA NETWORK (LAN)

    • Note: Appropriate safety instructions shall be followed as per the supplier manual.
    • Proper functioning and performance of IT systems play a major role in obtaining consistency, reliability, and accuracy of results.
    • The primary requirement for all IT systems is that they must be suitable for their intended purpose.
  • Identification / Naming of IT System:

    • All the major Network equipment shall have naming as follow
Network Rack CNLNUNFFNRK-X
CN Country
LN Location
UN Unit No. (Only if applicable)
FF Area Name (For e.g. FF First floor, GF Ground floor, SR Server room etc.)
NRK Abbreviation for Network Rack
X Alphabetical Number e.g. A, B, C D, etc.

 

Network Switches CNLNUNFFNSW-ZXX
CN Country
LN Location
UN Unit No. only if applicable
FF Area Name (For e.g. FF First floor, GF Ground floor, SR Server room etc.)
NSW Abbreviation for Network Switch
ZXX Z Alphabetical Number of Rack and XX serial no.  01, 02, 03…
    • Affix the number on the Network Switch and Rack.
    • List of Switch and Rack shall be prepared, with the numbers allotted, serial no. and location, etc., as per Annexure 1 and addition of switch, the rack will be list down in amendment list as per Annexure 9.
    • The list of switches and racks as per Annexure 1 will be revised once a year or as per requirement.
    • All IT network equipment shall be subjected to qualification in accordance with written qualification protocol, results shall be recorded in the qualification report.
    • The protocol shall be prepared by the IT department.
  • Qualification / Requalification Number:

    • For Qualification and Re-Qualification number shall have the following numbering.
    • AA/LN/YY/NE/XX
    • AA: Denotes abbreviations as URS, DQ, IQ, OQ, PQ, In case requalification include R before Q.
    • LN:  Is an abbreviation of the unit name
    • YY:  Year
    • NE:   NE for Network Equipment
    • XX       :   Number 01, 02, 03…
    • These numbers shall be issued by respective QA and records for the same shall be maintained in Annexure 2.
    • When the supplier / external agency shall perform the qualification, then qualification documents shall be checked and signed off by company IT personnel.
    • If the qualification documents are not provided by the supplier / external agency, then the required qualification documents shall be prepared by the IT department as per standard format (refer to Annexure 3 to 7).
  • User Requirement Specification (URS) – Local Area Network (LAN) :

    • URS shall be prepared by the IT department along with the inputs of the user department.
    • The same shall be approved by “Approved by Head Quality Assurance” and shall be authorized by the respective head of the department (In case of Projects, it will be authorized by system owner) (Refer Annexure 3).
    • Location and Unit: Respective Location and Unit shall be mentioned.
    • Version Number: Version no. of the document starts from ‘01’. It is revised with the revision in the document.
    • Supersedes: Supersedes date shall be mentioned in case of change in version. It shall be the date of issue of the previous version. In case of the first issue of a standard operating procedure, “—-’’ in bold shall be mentioned.
    • Index: An index shall consist of all the parameters to be included in the document.
    • Purpose: Describe the purpose of the IT System
    • Scope: Applicable to the procurement of IT systems in the respective Department.
    • Responsibility : Write the names / designation / department responsible for the procurement activity.
    • User Requirement Specification: Mention the Basic / Functional / Technical requirements such as make, model, capacity, expected output (but not limited to these).
    • Location Suitability: Mention as per the requirement.
    • Requirement Documentation: list of documents required such as operating manual, qualification documents, list of components, circuit / electric diagram (but not limited to these) shall be mentioned.
    • Training / Demonstration: Mention as per the requirement.
    • Safety Feature- Safety features such as emergency switch, safety valve, noise level, etc. shall be mentioned.
    • Final Approval: Final document approved by Department Head / System Owner and Head Quality.
    • Abbreviations: Abbreviations shall be mentioned in the document.
    • Any of the documents, such as Functional Design specification, if received from the vendor shall be compared with the URS
  • Design Qualification – Local Area Network (LAN):

    • Design qualification should be prepared based on the user’s requirement and functional design specification / technical specifications provided by the manufacturer / Vendor. (Refer Annexure 4).
    • Location And Unit: Respective Location and Unit shall be mentioned.
    • Version Number: Version no. of the document starts from ‘01’. It is revised with the revision in the document.
    • Supersedes: Supersedes date shall be mentioned in case of change in version. It shall be the date of issue of the previous version. In case of first issue of a standard operating procedure, “—-’’ in bold shall be mentioned.
    • Index: An index shall consist of all the parameters to be included in the document.
    • Purpose: Purpose of the Design qualification shall be written in this section
    • Scope: The scope of the document shall be mentioned in detail.
    • Qualification Team and Responsibility: The name of the personnel responsible for execution of the activity shall be mentioned in the qualification Team. System User / IT department shall prepare the document of Operational qualification along with the inputs of other respective departments and sign along with date. The same shall be approved by “Approved by Head Quality”. The respective head of the department shall authorize the Operational qualification document.
    • System Description: System description such as name of the IT System, Make and model of hardware, address of the manufacturer (but not limited to these), shall be mentioned. Purpose, principle of operation and physical verification of IT System on receipt shall be mentioned.
    • Pre-requisites shall be mentioned.

    • System Design / Technical / Utility Requirement: The list of main components with specification and required list of accessories/change parts shall be mentioned.
    • Location Suitability: If any special room requirement, it shall be mentioned in the document.
    • Safety Features: The necessary safety requirement for IT System such as earthing, moving parts shall be covered (but not limited to these) shall be mentioned
    • Documents to be attached:  The documents necessary shall be mentioned document such as the operation manual, assembly diagram, mechanical drawings, etc.
    • Recommendations / Conclusion: Recommendation and conclusion shall be mentioned.
    • Team Approval: System User / IT department shall prepare the document with Quality
    • Assurance of installation qualification along with the inputs and sign along with date
    • Final Approval: Final document approved by Department Head / System Owner and Head Quality.
    • Abbreviations: Abbreviations shall be mentioned in the document.
    • System User / IT department shall prepare the document of design qualification along with the inputs of other respective departments and sign along with the date. The same shall be approved by User Department. The respective head of the department shall authorize the design qualification document.
    • All other pages shall contain only the header as on the first page with respective page numbers and footer prepared by (System owner / IT department) and checked by QA along with signature and date.
  • Installation Qualification:

    • Installation qualification shall be prepared based manufacturer recommendation / manual (if available) (Refer Annexure 5).
    • Document number shall be mentioned.
    • Location and Unit: Respective Location and Unit shall be mentioned.
    • Version Number: Version no. of the document starts from ‘01’. It is revised with the revision in the document.
    • Supersedes: Supersedes date shall be mentioned in case of change in version. It shall be the date of issue of the previous version. In case of first issue of a standard operating procedure, “—-’’ in bold shall be mentioned.
    • Title as “Installation Qualification of Network Equipment” shall be mentioned.

    • Index: An index shall consist of all the parameters to be included in the qualification
    • Scope: Applicability of the document to the respective IT System shall be written
    • Qualification Team and Responsibility: The name of the personnel responsible for execution of the activity shall be mentioned in qualification Team.
    • IT department shall prepare the document of installation qualification along with the inputs of other respective departments and sign along with date.
    • The same shall be approved by “Approved by Head Quality Assurance”.
    • SOP Reference: Specify any referred SOP
    • System Description: System description such as the name of the IT System, Make and model of hardware, address of the manufacturer (but not limited to these), shall be mentioned. Purpose, the principle of operation, and physical verification of IT System on receipt shall be mentioned.
    • The list of components shall be verified for its serial no / service tag and model no.
    • Physical Verification: Physical verification shall be mentioned for Network switches, rack, LIU, jack panel, cable manager, IO connectors, cables, face plate etc. to state the System Hardware is intact in state.
    • System Technical Specification: System specification such as configuration IT systems, shall be mentioned.
    • Safety features: The necessary safety requirement for IT System such as earthing, moving parts shall be covered (but not limited to these) shall be mentioned.
    • Utilities: Utilities such as the Power supply required for the system shall be mentioned.
    • References: Required document shall be referred.

    • Documents to be attached: Corresponding documents w.r.t IT System shall be mentioned and attached.
    • Recommendation / Conclusion: Recommendation and conclusion shall be mentioned.
    • Review: Review and summary shall be mentioned.
    • Team Approval: System IT department shall prepare the document with Quality Assurance of installation qualification along with the inputs and sign along with the date.
    • Final Approval: Final document approved by Department Head and Head Quality.
    • All other pages shall contain only the header as on the first page with respective page numbers and footer with prepared by the IT department and checked by Quality Assurance along with signature and date.
  • Operational Qualification – Local Area Network (LAN)

    • Operational qualification shall be prepared based on requirements and manufacturer’s manual / recommendations and after completion of installation qualification (Refer Annexure 6).
    • Procedure related to IT System like operation, maintenance should be verified during Operational qualification. (If applicable)
    • Document number shall be mentioned
    • Location And Unit: Respective Location and Unit shall be mentioned.
    • Version Number: Version no. of the document starts from ‘01’. It is revised with the revision in the document.
    • Supersedes: Supersedes date shall be mentioned in case of change in version. It shall be the date of issue of the previous version. In case of the first issue of a standard operating procedure, “—-’’ in bold shall be mentioned.
    • Title as “Operational Qualification of (Name of the IT System)” shall be mentioned.

    • Index: An index shall consist of all the parameters to be included in the qualification.
    • Purpose: Purpose of the Operational Qualification shall be written in this section.
    • Scope: The scope of the document shall be mentioned in detail. Applicability of the document to the respective IT System shall be written.
    • Qualification Team and Responsibility: The name of the personnel responsible for execution of the activity shall be mentioned in the qualification Team. IT department shall prepare the document of Operational qualification along with the inputs of other respective departments and sign along with date.
    • The same shall be approved by “Approved by Head Quality”. The respective head of the department shall authorize the Operational qualification document.
    • Pre-requisite: Pre-requisites required for operational qualification shall be mentioned.
    • Training: Mention as per the requirement.
    • Technical Functioning shall be mentioned.

    • Safety features: The necessary safety requirement for the IT System such as earthing, moving parts shall be covered (but not limited to these) shall be mentioned.
    • Verification of SOP: Verify and Refer to respective SOP’s.
    • Document to be attached: Corresponding documents w.r.t IT System shall be mentioned and attached..
    • Recommendation / Conclusion: Recommendation and conclusion shall be mentioned.
    • Review: Review and summary shall be mentioned.
    • Team Approval: IT department shall prepare the document with Quality Assurance of Operational qualification along with the inputs and sign along with date.
    • Final Approval: Final document approved by Department Head / System Owner and “Head Quality Assurance”.
    • Abbreviations: Abbreviations shall be mentioned.
    • All other pages shall contain only the header as on the first page with Respective page numbers and footer with prepared by IT department and checked by Quality Assurance along with signature and date.
  • Performance Qualification – Local Area Network (LAN) :

    • Performance qualification should be prepared based on user’s requirement and functional specifications / technical specifications provided by the manufacturer (Refer Annexure7).
    • Document number shall be mentioned
    • Location and Unit: Respective Location and Unit shall be mentioned
    • Version Number: Version no. of the document starts from ‘01’. It is revised with the revision in the document.
    • Supersedes: Supersedes date shall be mentioned in case of change in version. It shall be the date of issue of the previous version. In case of the first issue of a standard operating procedure, “—-’’ in bold shall be mentioned.
    • Title as “Performance Qualification of (Name of the IT System)” shall be mentioned.

    • Index: An index shall consist of all the parameters to be included in the qualification.
    • Purpose: In brief for making this Performance qualification shall be mentioned.
    • Scope: Applicability of the document to respective IT System shall be written
    • Qualification Team and Responsibility: The name of the personnel responsible for execution of the activity shall be mentioned in Qualification Team. IT department shall prepare the document of Performance Qualification along with the inputs of other respective departments and sign along with the date. The same shall be approved by Quality Assurance. The respective head of the department shall authorize the Operational qualification document.
    • Variable to be met: Specify the Technical requirement
    • References: Required document shall be referred.
    • Documents to be attached: Required documentation during Performance Qualification shall be mentioned.
    • Recommendation / Conclusion: Recommendation and conclusion shall be mentioned
    • Review: Review and summary shall be mentioned

    • Team Approval: System User / IT department shall prepare the document with Quality Assurance of Operational qualification along with the inputs and sign along with the date
    • Final Approval: Final document approved by Department Head / System Owner and Head Quality.
    • Abbreviations: Abbreviation shall be mentioned
    • Document Approval: System User / IT department shall prepare the document of Performance qualification along with the inputs of other respective departments and sign along with the date. The same shall be approved by Head Quality”. The respective head of the department shall authorize the performance qualification document.
    • All other pages shall contain only the header as on the first page with Respective page numbers and footer with prepared by System Owner / IT department and checked by Quality Assurance along with signature and date.
    • After the completion of the Qualification activity handover certificate shall be given by the System User/IT department to the respective Department / Project Owner (Refer to Annexure 6).
    • Qualification shall be performed for any major equipment addition e.g. switch and rack.
    • Periodic requalification shall be done every five years.

    • Requalification is required for the addition of Local Area Network (LAN) points and after maintenance.
    • The requalification shall be prepared as per the respective formats shown in Annexure 5 to 7.
    • Layout shall be prepared by the engineering department with the help of the user.
    • In case major equipment addition e.g. Switch, Rack, Change Control procedure shall be followed.

6.0   REFERENCES

    • Guidelines for preparation and finalization of layouts for approval

7.0   ANNEXURES

Annexure 1 – List of Network equipment

Sr. No.

Equipment Type Make Model Port / No. of Unit Equipment

Serial No

Location Equipment Tag

Remark

 

Annexure 2 – Qualification / Requalification Document Number Issuance Log

Sr. No

Date Equipment Name URS No. with sign and date DQ No. with sign and date IQ No. with sign and date OQ No. with sign and date PQ No. with sign and date Issued to

Issued by

(QA)

Annexure 3 – User Requirement Specification of Local Area Network (LAN)

USER REQUIREMENT SPECIFICATIONS (URS)

Document No.: NETWORK EQUIPMENT Unit:
Version No.: Date of Issue:
Supersedes: Page x of x

 

USER REQUIREMENT SPECIFICATIONS (URS)

FOR

 NETWORK EQUIPMENT

INDEX

Sr. No. List of Content
1. Purpose
2. Scope
3. Responsibility
4. User Requirement Specification
4.1. Technical specification
4.2. Required Documents
5. Annexures
6. Abbreviations
7. Approval

 

1.0    PURPOSE :

    • To identify the IT Network Equipment and its design specification suitable for the application and process desired.
    • To provide a written document to suppliers/vendors with respect to the design requirements.           

2.0     SCOPE :

    • This URS will be recognized as an integral part of the procurement agreement with the selected vendor.
    • The supplier or vendor shall abide by the information and conditions set forth by this document as well as the standard purchasing terms and conditions of the company.

3.0      RESPONSIBILITY:        

    • System User / IT Department: ____________________________ (To prepare the qualification & verify the equipment after installation for all proposed parameters and document the same) [Individuals name to be recorded at the time of execution].
    • Engineering : _____________________________ (To provide & verify the utilities, certify components, location and equipment parameters) [Individuals name to be recorded at the time of execution].
    • HSE :_________________________________ (To verify the safety aspects of equipment and facility) [Individuals name to be recorded at the time of execution].
    • Quality Assurance : _________________ (To be a part of team) [Individuals name to be recorded at the time of execution].
    • Department Head / System Owner: ____________________________ (To review and approve the protocol) [Individuals name to be recorded at the time of execution].

4.0      USER REQUIREMENT SPECIFICATION:

    • Technical Specification (as Per the requirement)
Sr. No. Parameter Specifications Remarks
    • Required documents:
Sr. No. Parameter Specifications Remarks

5.0   ANNEXURES:

Sr. No. Annexure Details Annexure No.

6.0   APPROVAL:

PREPARED BY

APPROVED BY

AUTHORISED BY

System User  / IT department: Department Head  / System Owner : Head Quality Assurance

Annexure 4 – Design Qualification of Local Area Network (LAN)

DESIGN QUALIFICATION

Document No.:

NETWORK EQUIPMENT

Unit:
Version No.: Date of Issue:
Supersedes: Page x of x

 

DESIGN QUALIFICATION (DQ)

FOR

NETWORK EQUIPMENT

INDEX

Sr. No. List of Content
1. Purpose
2. Scope
3. Responsibility
4. Pre-requisites
5. Variables to be met
5.1. System Design / Technical Requirement
6. References, if any
7. Documents to be attached
8. Documents received from the supplier
9. Abbreviations
10. Report Approval

Annexure 5 – Installation Qualification of Local Area Network (LAN)

INSTALLATION QUALIFICATION

Document No.:

NETWORK EQUIPMENT

Unit:
Version No.: Date of Issue:
Supersedes: Page x of x

 

INSTALLATION QUALIFICATION (IQ)

FOR

NETWORK EQUIPMENT

INDEX

Sr.      No. List of Content
1 Purpose
2 Scope
3 Qualification Team & Responsibility
4 Standard Operating Procedure (SOP) reference, if any
5 System Description
6 Location Suitability
7 Physical Verification
8 Variables to be met
8.1 System Technical specification :
8.2 Safety features
8.3 Utilities
9 Verification of documents
10 References, if any
11 Documents to be attached
12 Deviations, If any
13 Recommendation / Conclusion
14 Review (Inclusive of follow up action, if any)
15 Team Approval
16 Approved by
17 Abbreviations

Annexure 6 – Operational Qualification of Local Area Network (LAN)

OPERATIONAL QUALIFICATION

Document No.:

NETWORK EQUIPMENT

Unit:
Version No.: Date of Issue:
Supersedes: Page x of x

 

OPERATIONAL QUALIFICATION (OQ)

FOR

NETWORK EQUIPMENT

INDEX

Sr.      No. List of Content
1. Purpose
2. Scope
3. Qualification Team & Responsibility
4. Pre-requisite
5. Training
6. Variables to be met
6.1 Technical Functioning
6.2 Safety features
7. Verification of standard operating procedure (SOP)
8. Reference, if any
9. Documents to be attached
10. Deviations, If any
11. Recommendation /Conclusion
12. Review (Inclusive Of Follow Up Action, If Any)
13. Team Approval
14. Approved by
15. Abbreviations

Annexure 7 – Performance Qualification of Local Area Network (LAN)

PERFORMANCE QUALIFICATION

Document No.:

NETWORK EQUIPMENT

Unit:
Version No.: Date of Issue:
Supersedes: Page x of x

 

PERFORMANCE QUALIFICATION (PQ)

FOR

NETWORK EQUIPMENT

INDEX

Sr.          No. List of Content
1. Purpose
2. Scope
3. Qualification Team & Responsibility
4. Variables to be met
5. References
6. Documents to be attached
7. Deviations, if any
8. Recommendation / Conclusion
9. Review (Inclusive of follow up action, if any)
10. Team Approval
11. Approved by
12. Abbreviations

Annexure 7 – Handover Certificate of Local Area Network (LAN)

     HANDOVER CERTIFICATE FOR

_____________________________________

 

This is to certify that the_________________________has been qualified and is herewith approved for regular usage in ____________________________ unit / department as on _____________ (date).

User/IT  Department: _________________________      Date: ________

Engineering: _______________________________       Date: ________

Safety: ___________________________________         Date: ________

Quality Assurance:  __________________________         Date: ________

Department Head:  __________________________           Date: ________   

Annexure 8 – Handover Certificate of Local Area Network (LAN)

Sr. No.

Equipment Type Make Model Port / No. of Unit Equipment

Serial No

Location Equipment Tag

Remark

Annexure 9 – Amendment list of Local Area Network (LAN)

Sr. No.

Equipment Type Make Model Port / No. of Unit Equipment

Serial No

Location Equipment Tag

Remark

Annexure 10 – Local Area Network (LAN) Requirement Request

Request Section <To be filled by requester>                            Date:               

Request Type:

(    )    New Data Point Request

(    )    Data Point Modification

(    )    Temporary Data Point Request

Network Type: 

(    )    New Data Point

(    )    Data Point

Existing Data Point Code:
Justification
Department

           

Area Location

Room No.

Nos. Data

 

  Name Remarks Sign / Date
Request raised by

(User Department)

     
Approval :
Head of the department      
Unit Head    
Engineering Department      
Changes Done by Point Assigned/Deleted/Modified  

Annexure 11 – Error Investigation form of Network Equipment – Local Area Network (LAN)

 Name of equipment:__________________________________________

Error Reported Date \ Time: ___________________________________

Description of error:    ________________________________________

Impacted Application / Process:__________________________________

Issue reported By:

________________                        ____________________                    ______________

Unit                                                 Department                                   Name Sign / Date

IT Team: ____________________

Name Sign / Date

Details of Investigation:__________________________________________________

Action Taken for resolution:_______________________________________________

Evaluation of Impact:___________________________________________________

Issue Resolution date \ time:_________________________ Actual Down time:________

Issue Resolved By:________________________________

Conclusion, Corrective Action & Preventive Action / Remedial Action (If required): Yes / No.____

IT Team  (Date \Sign)                                                          IT Head / Head Unit QA (Sign \ Date)

 

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Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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