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DOCUMENT APPLICATIONS

Introducing DOCUMENT APPLICATIONS, which indicates to users what documents are used where.............CLICK HERE TO VIEW OUR SITE STATISTICS...............LOOKING FOR PROMOTION?............ THEN CLICK HERE AND SEARCH OR REGISTER FOR PRIME UK AND INTERNATIONAL VACANCIES.
a

Computer =  C

Equipment =  E

Facilities                    = F

HVAC        =  H

Utilities      =  U

Procedural                 = P

Tools        =  T

Applicable  =  Y

Supplied in IQ or OQ = Y*

a

Template Description

C

E

F

H

U

P

T

21 CFR Part 11 Eligibility (Issue 3)

y*

y*

y*

 

y

 

 

Analog Address Verification (Issue 3)

y*

y*

y*

 

y*

 

 

Analog Loop Tests (Issue 3)

y*

y*

y*

 

y*

 

 

Application Software Identification (Issue 3)

y*

y*

y*

 

y*

 

 

Cabinet Temperature Mapping (Issue 4)

 

 

 

 

y

 

 

CAPA Audit (Issue 2)

 

 

 

 

 

 

y

CFR Part 11 Verification (Issue 3)

y*

y*

y*

 

 

 

 

Change & Consumable Parts Verification (Issue 3)

 

y*

y*

 

Y*

 

 

Computer Performance Qualification

y

 

 

 

 

 

 

Computer User Requirements Specification (Issue 5)

y

 

 

 

 

 

 

Computer Validation Master Plan (Issue 5)

y

 

 

 

 

 

 

Computer Vendor Audit (Issue 3)

y

 

 

 

 

 

 

Corporate Quality Manual (Issue 3)

 

 

 

 

 

y

 

Critical Area Material Verification (Issue 2)

 

y*

y*

 

y*

 

 

CSV Design Qualification (Issue 3)

y

 

 

 

 

 

 

CSV Installation Qualification (Issue 6)

y

 

 

 

 

 

 

CSV Operational Qualification (Issue)

y

 

 

 

 

 

 

CSV Validation Plan (Issue 3)

y

 

 

 

 

 

 

Definitive Validation Manual (Issue 3)

 

 

 

 

 

y

 

De-ionizer Unit Regeneration Test (Issue 1)

 

 

 

 

y

 

 

a

Design Qualification (Issue 4)

 

y

y

 

y

 

 

Electrical Conformance Verification (Minor) (Issue 3)

Y*

y*

y*

 

y

 

 

Equipment Functional Test (Issue 1)

 

y

 

 

 

 

 

Facility Installation Qualification (Issue 6)

 

 

y

 

 

 

 

Facility Operational Qualification (Issue 6)

 

 

y

 

 

 

 

Gap Analysis Tool (Issue 2)

 

 

 

 

 

 

y

HEPA Filter & Seal Integrity Test (Issue 5)

 

 

 

y*

 

 

 

HEPA Filter Clean PD Correction (Issue 5)

 

 

 

y*

 

 

 

HVAC New System Qualification Package (issue 3)

 

 

 

y

 

 

 

HVAC System DQ (Issue 3)

 

 

 

y

 

 

 

HVAC System IQ (Issue 6)

 

 

 

y

 

 

 

HVAC System OQ (Issue 6)

 

 

 

y

 

 

 

HVAC System PQ (Issue 4)

 

 

 

y

 

 

 

HVAC Validation Package (Issue 5)

 

 

 

y

 

 

 

Input Output Address Verification (Issue 3)

y*

y*

y*

 

y*

 

 

Installation Qualification SOP & Protocol (Issue 8)

 

y

 

 

y

 

 

Operating System Software Verification (Issue 3)

y*

y*

y*

 

y

 

 

Operation Qualification SOP & Protocol (Issue 9)

 

y

 

 

y

 

 

Performance Qualification (Issue 5)

 

 

 

 

y

 

 

a

Pipe Work Record Tests & Inspections (Issue 3)

 

y*

y*

 

y*

 

 

Power Failure Test (Issue 3)

y*

y*

y*

 

y

 

 

Preicate Rules (Issue 3)

 

 

 

 

 

y

 

Process Qualification (P2Q) (Issue 4)

 

y

 

 

y

 

 

Process Valves Tests & Inspections (Issue 6)

 

y*

y*

 

y*

 

 

Quality Water Alarm (Issue 3)

 

 

 

 

y

 

 

Radio Interference Verification (Issue 5)

y*

y*

y*

 

 

 

 

Room Airflow Regime (Issue 3)

 

 

y

 

 

 

 

Safety/Health/Environmental Assessments (Issue 2)

y*

y*

y*

y

 

 

 

Security of Back-up Software (Issue 3)

y*

y*

y*

y*

y*

 

 

Sensor Calibration Verification (Issue 3)

y*

y*

y

y*

y*

 

 

Software Quality Verification (Issue 3)

y*

 

 

y

 

 

 

SOP for a SOP (Issue 3)

 

 

 

 

 

y

 

SOP for cGMP Review (Issue 3)

 

y

 

 

 

y

 

SOP for Equipment Validation (Issue 6)

 

 

 

 

 

y

 

Steam Quality Validation (Issue 2)

 

 

 

 

y

 

 

System Component Verification (Issue 2)

y*

y*

y*

y*

y*

 

 

System Documentation (SOP) Verification (Issue 3)

y*

y*

y*

y*

y*

 

 

System Documentation (IQ) Verification (Issue 3)

y*

y*

y*

y*

y*

 

 

System Drawing Verification (Issue 2)

y*

y*

y*

 

y*

 

 

a

System Future Maintenance Verification (Issue 3)

y*

y*

y*

y*

y*

 

 

Test Equipment Calibration Verification (Issue 6)

y*

y*

y*

y*

y*

 

 

User Requirements Specification (Issue 7)

y

y

y

y

y

 

 

Validation Document Matrix (Issue 4)

y

y

y

y

y

y

 

Validation Master Plan (Issue 6)

y

y

y

 

y

y

 

Validation Package Level 1 (Issue 3)

 

y

 

 

 

 

 

Validation Package Level 2 (Issue 3)

 

y

 

 

y

 

 

Validation Package Level 3 (Issue 3)

 

y

 

 

 

 

 

Validation Plan (Issue 6)

 

y

 

y

y

y

 

Validation Risk Assessment (Issue 8)

y

y

y

 

y

 

 

Vendor Audit Check List (Issue 2)

 

 

 

 

 

 

y

Vendor Audit Document (Issue 4)

 

 

 

 

 

 

y

Verification Of Lubricants (Issue 2)

 

y*

y*

y*

Y*

 

 

Verification of Password Controlled Access (Issue 2)

y*

y*

y*

y*

Y*

 

 

Verification of Vessel Installation (Issue 3)

 

 

y

 

Y*

 

 

Water Velocity Test (Issue 3)

 

 

y

 

y

 

 

Zone Room Air Change Rates (Issue 3)

 

 

 

y*

 

 

 

Document Apllications - Document Applications - Document Applications>

DOCUMENT APPLICATIONS


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