Developing SOPs that define the procedures and rules for the validation of a computer system. These SOPs ensure that the system is validated according to established standards, validation practices, and applicable regulatory requirements.

• Prospective & Retrospective Validation
• Developing a Project Validation Plan
• Developing Requirements Specification(s)
• Developing a Qualification Plan
• Developing a Validation Summary Report

Our regulatory solutions include Developing Business and Technical SOPs. Our Business (User Department) SOPs define your procedures and rules for the use of the computer system(s). Our Technical (Information Technology) SOPs define the procedures and rules for the administration and maintenance of your system(s).

The software specific SOP will include:

• System Use (either a Work Instruction or SOP)
• System Administration

Other suggested SOP (site wide) should include:

• Backup/Recovery/Archiving
• Disaster Recovery
• Security (this includes physical and logical)
• Problem Reporting
• Periodic Reviews
• Change Management / Configuration Management
• Training