Implementation Life-cycle SOP

Transcription

1 1.0 Commercial in Confidence 11-Aug of 12 Implementation Life-cycle SOP Document No: H4_SOP_0100 Prepared by: David Brown Date: 11-Aug-2006 Version: 1.0

2 1.0 Commercial in Confidence 11-Aug of 12 Document Approval Name Role Date Signature David Brown Author Document Control Version Author Date Description 1.0 David Brown 11-Aug-2006 Version 1

3 1.0 Commercial in Confidence 11-Aug of 12 Table of Contents 1 Introduction Purposes Scope Definitions Responsibility Procedure Initiation Phase Design Phase Installation Qualification (Operational Qualification) Phase Operational Qualification (System Test) Phase Production Installation Phase Operation and Maintenance Phase (Production Qualification) Appendix 1 - Documents Identified in the SOP... 12

4 1.0 Commercial in Confidence 11-Aug of 12 1 Introduction 1.1 Purposes The purpose of the Standard Operating Procedure is to outline the process to be followed when a company wishes to implement a validated computer system. The following diagram provides a visual overview of the process and high level SOPs for the protocols required to control the validation process. Validation Determination Statement SOP_0200 Implementation Lifecycle SOP_0100 Validation Plan SOP_0300 Design Qualification SOP_0400 (Protocol) Installation Qualification SOP_0500 (OQ Testing) Operational Qualification SOP_0600 (Protocol) Installation Qualification SOP_0400 (Production Testing) Validation Summary Report Update after every execution Validation Summary SOP_0700 System Live Production Qualification SOP_0800 (Periodic) Validation Change Control SOP_0900

5 1.0 Commercial in Confidence 11-Aug of Scope This procedure shall apply for all validated computer systems. 1.3 Definitions 1.4 Responsibility Project Team - The group of associates that come together for a specific purpose. The group maybe composed of business clients, Support, Validation, and other areas necessary for the successful completion of a project. Client they business system owner is typically the line manager responsible for the business process where the computer system will be used. Validation Group the group responsible for ensuring that computer systems are implemented and maintained in a validated state. IT Group the group responsible for development, operation, and maintenance of computer systems. It is the responsibility of the business system owner, system development and support group, and validation to ensure that this procedure is followed. 1.5 Procedure The procedure will be used for the implementation, configuration, and maintenance of all applications that are supported. Items appearing in quotations ( ) are deliverables from the process described in this procedure. The specific format and contents of these deliverables is detailed in separate SOP documents. Each document will be routed to various groups for approval signature. The groups are identified as 'IT' IT group, 'C' - Client, and 'V' - Validation. Refer to Appendix 1 for a list of documents that must adhere to the general format requirements defined in SOP SOP_0102 Documentation Standards.

6 1.0 Commercial in Confidence 11-Aug of 12 2 Initiation Phase A new project to introduce a computer system into a business area in the pharmaceuticals industry that may directly or indirectly be required to meet regulatory requirements must follow the validation process. The Validation Group will carry out a validation determination assessment to decide whether the new computer system, or change to an existing system, requires validation. The output from the validation assessment will be a Validation Determination Statement. If the new environment or change requires validation a Validation Plan will be prepared. The Validation Plan will detail the deliverables, and responsibilities for validation activities. Deliverable Prepare Approve Procedure Inputs: User Requirement Outputs: Validation Determination Statement V IT,V,C SOP_0200 Validation Plan V IT,V,C SOP_0300 Design Qualification V IT,V,C SOP_0400 Vendor Audit Report(s) if required V IT,V,C SOP_0111

7 1.0 Commercial in Confidence 11-Aug of 12 3 Design Phase During the Design Phase, the Project Team creates the Configuration Specification. The Configuration Specification explains how the application will be deployed. The nature of the Configuration Specification will vary according to specific requirements of the computer system and existing infrastructure. Before the Configuration Specification is approved, a review of the design will be performed to ensure all aspects of the Functional Requirements Specification are covered. Any differences identified in this review will be documented in the Configuration Specification. Once the Configuration Specification is approved, any further requirement changes are amended to the Configuration Specification and to the Functional Requirements Specification. If the design requires use of new deployment tools or study implementation approach, separate standards and conventions shall be written. When the test or production environments are implemented the configuration is under change control. An Installation Qualification describing the protocol to be used to ensure the quality of the installation will be created. Installation Plans are written for each hardware/software platform used in testing or production and referenced within the Installation Qualification. The Installation Plan describes how the Application will be introduced into the Test and Production environment. Deliverable Prepare Approve Procedure Inputs: Functional Requirements Specification Design Qualification (Pre-Approved) Outputs: Configuration Specification IT IT,V,C SOP_0104 Environment Naming Conventions IT IT SOP_0105 Completed Code Reviews IT IT,V SOP_0401 Unit Test Reports IT IT,V SOP_0402 Configuration Management Plan IT IT,V SOP_0113 Design Qualification (Approved) V IT,V,C SOP_0400 Installation Qualification V IT,V,C SOP_0500 Installation Plan(s) IT IT,V SOP_0501

8 1.0 Commercial in Confidence 11-Aug of 12 4 Installation Qualification (Operational Qualification) Phase During the system test installation qualification phase, the software and supporting hardware will be installed into a test environment and configured by following protocols described in the Installation Qualification and associated Installation Plans. Inputs: Deliverable Prepare Approve Procedure Installation Qualification (Preapproved) Installation Plan(s) Tested Software Modules Outputs: Configuration Specification IT IT,V,C SOP_0104 Environment Naming Conventions IT IT SOP_0105 Configuration Management Plan IT IT,V SOP_0113 Installation Qualification (Approved) V IT,V SOP_0500 Installation Report IT IT,V SOP_0501

9 1.0 Commercial in Confidence 11-Aug of 12 5 Operational Qualification (System Test) Phase The validation and client groups test the configured environment. The Operational Qualification and associated System Test Cases define how the system will be tested. The System Test Cases are derived from the Functional Specification and describe how the patient data gathering environment will function. It is expected that the Installation Phase may be revisited as the result of failed system tests. The Computer Operations Manual describes how the computer operators will support the Production Environment. The Disaster Recovery Plan describes how the disaster recovery requirements identified in the Functional Requirements Specification are met. Inputs: Deliverable Prepare Approve Procedure Configuration Specification Functional Specifications Operational Qualification (Pre- Approved) Outputs: System Test Plan(s) V IT,C,V SOP_0601 System Test Case(s) V IT,C,V SOP_0602 System Test Results V IT,C,V SOP_0602 Operational Qualification (Approved) V IT,C,V SOP_0600 Computer Operations Manual IT IT,V SOP_0108 Disaster Recovery Plan IT IT,C,V SOP_0110

10 1.0 Commercial in Confidence 11-Aug of 12 6 Production Installation Phase During the production installation phase the application is installed for production use by following the instructions in the Installation Plan for this platform. This may include running in parallel with existing systems, out-of-hours installation, etc. During the Installation Phase, an Installation Report is generated describing any anomalies or changes required to actually install the system in the Production Environment. The project team will develop the Application Access Matrix Form to document the granting of access to the application. Installation Phase activities include completing Validation documents such as: the Design Qualification which documents the design of the computer system; the Installation Qualification which documents the hardware, software, supporting development documents, and relevant client documents such as Standard Operating Procedures; the Operational Qualification which provides evidence that the system will perform as described in the Functional Requirements Specification; and the Validation Summary Report which summarizes the Validation effort, authorizes the system to be released for production use according to the Installation Plan, and documents any limitations in use of the system. Inputs: Deliverable Prepare Approve Procedure Production Installation Qualification (Preapproved) Installation Plan(s) Outputs: Installation Report IT IT,V SOP_0501 Application Access Matrix Form IT IT,C,V SOP_0107 Installation Qualification (Approved) V IT,C,V SOP_0500 Validation Summary Report V IT,C,V SOP_0700 Production Qualification V IT,C,V SOP_0800

11 1.0 Commercial in Confidence 11-Aug of 12 7 Operation and Maintenance Phase (Production Qualification) The Operation and Maintenance phase is ongoing. During this phase production qualifications must be run at scheduled intervals to ensure that the system has been maintained in a validated state. For each production system an incident log will be maintained. The IT group will create for each incident an Incident Report to record the anomalous behaviour and whether or not the behaviour results in a change to the Application. The IT Group will send a copy of the Incident Report to the Validation Group prior to making any changes to a validated system. The Validation Group will then submit a Validation Change Control Form (VCC), which describes validation activities that must occur to effect the change, to the IT Group. Changes made to validated applications must not be used in production until the "Validation Change Control Form" has been finally approved. In making changes to the application, consideration must be given to identify which documents will be affected by the change. The Validation Change Control Form will be used to identify which documents will require amendments due to a change in the application. Inputs: Deliverable Prepare Approve Procedure Computer Operations Manual Configuration Management Plan Production Qualification(s) (Pre- Approved) V IT,V,C SOP_0800 Outputs: Incident Report IT IT,V SOP_0106 Incident Log IT IT,V SOP_0106 Validation Change Control Form V IT,V,C SOP_0900 Production Qualification(s) (Approved) V IT,V,C SOP_0800

12 1.0 Commercial in Confidence 11-Aug of 12 8 Appendix 1 - Documents Identified in the SOP SOP No. Deliverable Title Complies with SOP_0102 Doc. Type SOP_0104 Configuration Specification Yes CS SOP_0105 Environment Naming Conventions No EC SOP_0106 Incident Report No IR SOP_0106 Incident Log No IL SOP_0107 Access Authorization and Security No AA SOP_0107 Application Access Matrix Form No AM SOP_0108 Computer Operations Manual Yes CM SOP_0109 Backup and Archival No BA SOP_0110 Disaster Recovery Plan No DRP SOP_0111 Vendor Audit Yes VA SOP_0113 Configuration Management Plan Yes CP SOP_0200 Validation Determination Statement Yes VD SOP_0300 Validation Plan Yes VP SOP_0400 Design Qualification Yes DQ SOP_0401 Code Reviews Yes CR SOP_0402 Unit Testing Yes UT SOP_0500 Installation Qualification Yes IQ SOP_0501 Installation Plan Yes IP SOP_0501 Installation Report Yes IPR SOP_0600 Operational Qualification Yes OQ SOP_0601 Test Plan Yes TP SOP_0602 Test Case & Results Yes TC SOP_0700 Validation Summary Report Yes VS SOP_0800 Production Qualification Yes PQ SOP_0900 Validation Change Control Form No VC