Documentation

 

Document Control

Change Control

Good Documentation Practices

Protocols

Equipment Qualification – Installation, Operational, Process Performance

Quality Manual

Quality Assurance

Quality Control

New Product/New Equipment/Transfer Protocol

Employee Handbook

Organization and Personnel

Retains

Complaints

Sampling

Instrument Lifecycle/Calibration Program

Preventative Maintenance Program

Computer System Validation

Decommissioning

Data Retention

IT Policies

System Review/Audit

Vendor Management

Safety Policies

Master Batch Records

[Individual process procedures]

[Individual equipment procedures]