Sunday, November 9, 2008

Computerised System Validation Part 2

To view Computerised System Validation Part 1 Click Here
The responsibility of the personnel associated with computerised systems is to
ensure that they understand the requirements of Computerised System Validation and comply with it. This guideline should be used by individual sites/departments as appropriate to prepare
their own local procedures. Validation and regulatory compliance is the responsibility
of each site/department and should be incorporated into their quality planning. Local
user, IT, controls engineers, laboratory technicians, and QA are expected to take an
active role. The senior management role is usually conducted in conjunction with
QA. Emphasis between roles will vary depending on the nature of the work being
1.Senior Management
Responsible for:
- Providing adequate resources.
- Final authorisation of the validated system for use.
2. System Owner/User Role
Responsible for:
- Validation activities associated with any aspect of the requirements definition, acceptance and use of a computerised system.
- Defining the system requirements.
- Ensuring that the system is validated and used in a compliant manner.
- Ensuring that appropriate user procedures are in place.
- Ensuring that system end users/operators are trained.
- The integration of the computerised system with existing processes, infrastructure and ways of working.
3. Project Manager
Responsible for:
- Ensuring that validation activities associated with any aspect of the development, provision, implementation and handover to the user of a computerised system are conducted in accordance with agreed plans.
4. Developer/Technical Role
Responsible for:
- All technical aspects of the system development and validation including preparing specification and design documentation.
- The technical implementation and delivery of the computerised system including preparing test documentation, conduct testing, etc.
5. Support/Maintenance Role
Responsible for:
- Ensuring that appropriate support and maintenance procedures are in place.
- All technical aspects of the system support and maintenance whilst the system is in use including documentation not covered by QA/Validation.
6. QA/Validation Role
- Preparing and approval of validation plans and of associated validation reports.
- Providing key validation activities and approvals as defined in validation plans such as supplier audits, qualification plans/reports, change control records, and configuration management.
- Authorising validated computerised systems as fit for purpose.
- Provide GxP and regulatory input into validation projects with particular focus on product quality impact.
- Conducting compliance audits on the implementation of Computerised System Validation in
support of ’regulated’ computerised systems.
To view Computerised System Validation Part 3 Click here

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