JMI Hospital Requisite Mfg. Ltd.

User Requirements Specification (URS)

System:

Document No. : Revision No.: Effective Date :

Prepared by: Signature: Date:

Name:
Designation: ___________________________
Checked by: Signature: Date:

Name:
Designation: ___________________________
Reviewed by: Signature: Date:

Name:
Designation: ___________________________
Approved by: Signature: Date:

Name:
Designation: ___________________________

Document history:

Revision No. Date Author Comments

Page 1 of 3
Doc. No : VMP/QA/01-F01-01, Revision No. : 01, Effective Date: June 2023
 JMI Hospital Requisite Mfg. Ltd.

User Requirements Specification (URS)

System:

Document No. : Revision No.: Effective Date :

1. Overview

2. SCOPE

3. Requirements

3.1 Process and Operational Requirements (PO)

Sl No. Requirements Criticality*

3.1 Process Requirements:

3.2 Operational Requirements:

3.2 Design and Environment Requirements (DE)

URS ID Requirements Criticality*

3.3 Regulatory Requirements (R)

URS ID Requirements Regulatory

Reference

3.4 Regulatory Requirements for e-record systems (21 CFR Part11) (ER)

URS ID 21CFR11 Requirement Description Y/N Comment

Ref.

3.5 Regulatory Requirements for e-signature systems (21 CFR Part11) (ES)

URS ID 21CFR11 Requirement Description Y/N Comment

Ref.

Page 2 of 3
Doc. No : VMP/QA/01-F01-01, Revision No. : 01, Effective Date: June 2023
 JMI Hospital Requisite Mfg. Ltd.

User Requirements Specification (URS)

System:

Document No. : Revision No.: Effective Date :

3.6 Data & Documentation Requirements (D)

URS ID Requirements Business

Criticality*

3.7 Validation Requirement

Record Regulation Retention Period

3.8 User Role Requirements (A)

URS ID Requirements Business

Criticality*
3.8.1 Installation / Commissioning / Training / Validation :

3.9 Service Requirements (S)

URS ID Requirements Business

Criticality*

3.10 Other Requirements (If any)

URS ID Requirements Criticality*

Note: * E – Essential
D – Desired
I – Important

Page 3 of 3
Doc. No : VMP/QA/01-F01-01, Revision No. : 01, Effective Date: June 2023