Visio Flow Of Instrument Process

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Conceptual Design –System Owner (SO)

SO establishes Design Team (DT)

DT establishes / revises concept

SO submits concept to Management for approval

DT establishes design specifications for DQ inclusion

Finalize / Revise DQ per SOP Requirements

SO submits DQ to DC for review (Change Ctrl SOP)

DQ Approved

Concept approved

DQ filed in Central Files

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Design Qualification

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DT obtains a Design Qualification (DQ) number from Doc. Ctrl (DC)

LifeCycle Management SOP

Equipment LifeCycle Management

New instrument is received

System Change Authorization (SCA) initiated

Part 1 of Equipment Registration Form completed/revised

QC assigned Asset Number

SO forwards form to QA for approval

Form Approved

QA assigns Maintenance Logbook

QA returns form to SO

SO applies Asset Tag

SO creates the Master Equipment File (MEF), filed by Asset Number

SO completes / revises section 3 (Calibration) of Registration Form

Instrument to be calibrated

Section 3 ‘ N/A’

SO forwards Equipment Registration From to QA for approval

Form Approved

Equipment Registration Form filed in MEF

SO defines frequency and tests per SOP

Calibration Interval/Test Adjustment

4 Successful Calibrations

No unscheduled Cal. maintenance

No deviations attributed to Cal. activities

SCA Initiated

Not eligible for Calibration Adjustment

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Instrument Retired

SCA Initiated

SO completes (revises) Sect. 4 of Equip. Registration Form

Date of last GMP activity ‘ N/A’d

MEF retention period documented (5 yrs from date of retire)

SO makes entry into Equipment Logbook

QA returns form and logbook to SO

SO archives Registration Form and Equip. Logbook in MEF

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Master Equipment File Archiving

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Date of Last GMP Activity Known

Date of last GMP activity documented

MEF retention period documented (5 yrs from GMP activity)

SO completes/ revises Equip. Registration From

SO forwards Registration form and Equip. Logbook to QA

QA Approval

System Change Authorization

SO completes/ revises section 1 of SCA Form

SO submits SCA form to Quality Management for Approval

Deviation from plan

SO provides a summary of all deviations with justification

SCA form approved

Quality Management returns form to SO

SO schedules change to take place / service rep

SO oversees all change activities

Inadequate Justification

SO consults with Quality Management / Vendor to resolve the issue

SO documents/ revises the plan as an attachment to the SCA Form

SO signs and forwards to QA for approval

QA Approval

Plan scheduled and executed

SO submits SCA form to QM for approval

SO reviews all Documentation

Vendor corrections

Vendor contacted and corrections made

SO completes / revises section 2 of SCA form

SCA form returned to SO by Quality Management

SO makes equipment logbook entry

SO updates any needed calibration information

Documentation filed in MEF

SCA form approved