Thursday, October 8, 2009


1.0 Company Information

1.1 Human and Financial resources.

1.2 Knowledge of GMP requirements

1.3 Organization

a) Structure

b) Responsibilities.

1.4 Customer Support

a) Installation and service.

b) Technical support

c) User training.

2.0 Quality System –General.

2.1 Management’s stated policy and commitments.

2.2 Quality group’s responsibility and authority.

2.3 Written Company quality plan.

2.4 Management Review of quality system.

3.0 Quality System –Software Development.

3.1 Development Plan

a) Functional Requirements.

b) Software design specifications.

c) Programming standards and procedures.

d) Programming tools.

e) Review procedures.

3.2 Test Plan

a) Types of Tests.

b) Test tools and methods.

c) Error correction and re-test.

d) Test review.

e) Acceptance criteria.

f) Test reports.

3.3 Configuration Management.

a) Organization and responsibilities.

b) Identification and traceability.

c) Configuration tools.

d) Change control procedures.

e) Version identification control policy.

f) Release approval procedures.

g) Configuration history and status report.

3.4 Program Documentation

a) Source code.

b) Logic diagrams.

c) List of all inputs and outputs.

d) List of all modifiable parameters.

e) List of all operator inputs.

f) Description of interfaces to other systems.

g) Description of alarms and interlocks.

h) Description of error detection and recovery.

i) Description of all data displays.

j) Description of all reports.

3.5 Document Control

a) Documents to be controlled.

b) Approval of issue procedures.

c) Change control procedures.

d) Retention and security procedures.

3.6 Personnel Qualification

a) Formal education.

b) Internal training.

c) Experience in software development.

d) Experience with specific programs used.

e) Experience with application.

4.0 Product Information

4.1 Validation Features.

a) Security.

b) Self documentation.

c) Automatic program change audit trail.

d) Simulation capability.

e) Program compare.

f) Revision documentation detail.

4.2 History of Use

a) Customers of all version.

b) Customers of present version.

c) Configuration history and status report.

4.3 Expected File

a) Present version

b) Revised products.

4.4 Revision Policy

a) Notification of problems.

b) Change required to fix problems.

c) Change to add or modify features.

d) Notification of revisions.

e) Support old versions.

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