Validation Title: 

Project #:     

Validation #: 

Asset #/ID:

SN:

Vendor: 

Equipment Description: 

Item

Requirements

Disposition

(Complete Y/N)

Documentation Location

Date

Descriptions & Specifications

Equipment and layout drawings, manuals or other written description.

Utility connections

Power: ________watts

Air: _________ psi

Gas:________ 

Water:_______

Environment

Temperature: _____°C       Light:_________

Relative Humidity:____% Vibrations: _____

Particulate: _______           EMR: _________

Calibration

Calibration Procedure in Place:________

Calibration Interval Established:_______

Calibration is Current:_________

Preventive Maintenance

PM procedure is complete: __________

Spare parts inventory complete:_______

PM intervals are established:_________

PM is current:_____________________

Vendor Contacts

Service contacts identified:___________

Calibration contacts identified_________

Spare parts contacts identified:_________

Operating Procedures

Operating procedures complete:__________

Procedure accessible by operators:________

Critical process parameters identified:______

Tolerances, and control plan established:___

Operator Training

Training records complete and current for all equipment operators.

Operational Qualification

Equipment operates satisfactorily at extremes of all critical operating parameter tolerances