DUKE - EMMESspitfire.emmes.com/study/duke/SOP/Common Quality...Installation Checklist for Environmental and Utilities Requirements List utilities necessaiy to properly operate the

DUKE

DOCUMENT NUMBER: COMM-QA-044 FRM1

DOCUMENT TITLE:Instrument Equipment Validation Protocol FRM1

DOCUMENT NOTES:Document required for the BLA.

Document Information

Revision: 04

Status: Release

Date Information

Creation Date: 02 Nov 2018

Effective Date: 17 Jul 2019

Control Information

Author: LE42

Previous Number: COMM-QA-044 FRM1 Rev 0:B

Vault: COMM-QA-rel

Document Type: COMM-QA

Release Date: 17 Jul 2019

Expiration Date:

Owner: BS76

Change Number: COMM-CCR-081

CONFIDENTIAL - Printed by: BJ42 on 17 Jul 2019 07:46:36 am

Protocol Number:

Instrument/Equipment Validation Title:

Prepared By:

Approved By:Department Supervisor/Manager

Approved By:Medical Director

Approved By:Quality Systems Unit

Date:

Date:

Date:

Date:

COMM-QA-044 FRM1 Instrument Equipment Validation ProtocolOffice of Regulatory Affairs and Quality, Duke UniversityDurham, NC Page 1 of 1:


This form is to be used as a guide in the development of an instrument/equipment qualificationprotocol. Based on type of qualification to be performed, applicable contents can be importedinto an MSWord dociiment to create the protocol and final report.

1. Table of Contents

1. Table of Contents...............................................................................................................^

2. Background.........................................................................................................................32. 1 Purpose.........................................................................................................................32.2 Maintenance, Cleaning and Re-Qualification Schedule .................................................32. 3 Supplemental Data/Infomiation.....................................................................................3

3. INSTALLATION QUALIFICATION (IQ) .........................................................................33. 1 Scope and Responsibility ..............................................................................................33. 2 Reference(s)..................................................................................................................33. 3 Documentation..............................................................................................................3

3.4 Installation Checklist for Environmental and Utilities Requirements .............................43. 5 System Features...........................................................................................................^3. 6 Uncrating Procedure .....................................................................................................43. 7 Installation Procedure...................................................................................................^3. 8 Calibration/Preventive Maintenance Procedures............................................................5

3. 9 Safety/Enviromnental Evaluation..................................................................................53. 10 Spare Parts List.............................................................................................................53. 11 Acceptance Criteria......................................................................................................^

4. OPERATIONAL QUALIFICATION (OQ).........................................................................74. 1 Scope and Responsibility ..............................................................................................74. 2 Reference(s)..................................................................................................................74. 3 Documentation..............................................................................................................?

4.4 Test Module Acceptance Criteria ..................................................................................74. 5 OQ Procedure...............................................................................................................74. 6 Verification of SOPs.....................................................................................................74. 7 Test Modules ................................................................................................................8

5. PERFORMANCE QUALIFICATION (PQ)........................................................................95. 1 Scope and Responsibility ..............................................................................................95. 2 Reference(s)..................................................................................................................95. 3 Documentation.............................................................................................................^

5. 4 Test Module Acceptance Criteria...................................................................................95. 5 PQ Procedure................................................................................................................95.6 Verification of SOPs.....................................................................................................95. 7 Test Modules .............................................................................................................. 10

6. Amendment Revision History (as applicable) .................................................................... 107. Final Protocol Summary Report......................................................................................... 11

COMM-QA-044 FRM1 Instrument Equipment Validation ProtocolOffice of Regulatory Affairs and Quality, Duke UniversityDurham, NC Page 2 of 11


2. Background2. 1 Purpose

Identify the instrument/equipment to be validated. Include all pertinent information todistinguish the mstrwnent/equipment from others of its make and or equivalent design.Specify the intended use for the instrument/equipment and performance requirements.

Table 2.1

Instrument/Equipment Name

Manufacturer

Model Number/Unit Type

Serial Number

Internal Identification Number

Location of Instrument/Equipment

Intended use of

Instrument/Equipment

Performance Requirements

2.2 Maintenance, Cleaning and Re-Qualification ScheduleDescribe plans for maintenance, cleaning, and re-qualification for thisinstrument/eqiiipment, if applicable.

2.3 Supplemental Data/InformationDescribe any supplementaiy data/reports/summaries or company-driven proceduresexpected. These may be appended to the final report.

3. INSTALLATION QUALIFICATION (IQ)3. 1 Scope and Responsibility

Insert information about scope, such as the test procedures and acceptance criteriaspecific to this qualification. Identijy who will be completing the validation and describerequired pre-validation training including who will be conducting the training, ifapplicable.

3.2 Reference(s)List any reference standards used for IQ of the instrument/equipment.

3.3 Documentation

List SOPs, attachments, or operator 's manuals needed for IQ.



3.4

3.5

Installation Checklist for Environmental and Utilities RequirementsList utilities necessaiy to properly operate the instrument/equipment.

ExampleThe following utilities are necessary to properly operate the XXX and are available atthe XXX location. Refer to Operator's Manual for more information. (Add/Delete asapplicable)

Table 3.1

Utility

Electricity

SpaceRequirementsHumidityAmbient

Temperatvre

Specification

Volt!Herti

Amps

Temperature Range:

Additional

RequirementsUtilities as

FoundAvailable

Yes No

Yes No

System FeaturesDescribe system features of the instrwnent/equipment being validated.

Example:

System featiires are described in detail in the Operator 's Manual. A copy of the manualis located in this document, in Appendix X.Table 3.2

System Feature Specifications Range

3.6 Uncrating ProcedureDescribe steps for uncrating or unpackaging the instrument/eqi iipment. (Refer to

operator 's manual. ) If already in use, state that the mstrument/equipment was already inuse. List all of the components required to complete the instrument/equipment mstallationand specify if available.



Table 3.3 Instrument/Equipment VerificationInstrument/Equipment Catalogue

NumbersAvailable

(circle one)Yes NoYes NoYes NoYes No

3.7 Installation Procedure

List the steps to properly install the instrwnent/equipment as defined in the operator 'smanual. If the equipment is portable, refer to the steps in the manual defined for prior tofirst use, e. g., install a battery, limited assembly, or proper connection to a power supplyto perform OQ.

3.8 Calibration/Preventive Maintenance Procedures

Note any special maintenance requirements. Determine if an SOP is needed. Attachcalibration certificates as part of the OQ.

3.9 Safety/Environmental EvaluationIdentify any safety features or special safety handling operating requirements here.Identify any special protective equipment that will be needed to operate the eqiiipment.Ensure that any special safety devices have been installed. Identify any specialenvironmental concerns such as disposables, biological or hazardous waste, with apotential release into the environment.

3. 10 Spare Parts ListIdentify the part mmiber of any spare parts that may be required for theinslrument/equipment. If the list is lengthy, ensare that a parts list is copied and attackedto a labeled Appendix.

Table 3.4

Spare Part Catalogue Number



3. 11 Acceptance Criteria

Table 3.5 Circle yes/no, as applicable.1. All procedural steps contained in this document have been

followed.

2. Any and all deviations from the approved protocol have beendocumented and approved.

3. All applicable space, environmental and utility requirementshave been met.

4. The equipment has been installed or set up according to themanufacturer 's instructions. Exceptions have been noted andapproved in a deviation report.

5. All safety, environmental and warranty information have beenidentified and documented.

6. Master Equipment List updated.

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No



4. OPERATIONAL QUALIFICATION (OQ)

4. 1 Scope and ResponsibilityInsert information about scope, such as the test procedures mid acceptance criteriaspecific to this qualification. Identify -who will be completing the work and describerequired pre-validation training including who will be conducting the traming, ifapplicable.

4.2 Reference(s)List any reference standards used for OQ of the mstrumefit/equipment.

4.3 Documentation

List SOPs, attachments, or operator 's manuals needed for OQ.

4. 4 Test Module Acceptance Criteria. All test modules must be performed according to the procedure included in each

test module.

. Failure of any or all of the replicate data sets to meet acceptance criteria willconstitute a trial failure. If a root cause can be found for one trial failure, thesingle trial is repeated under the corrected condition and with the approval ofQSU. If no root cause is found, all replicates must be repeated.

. In the event of a trial failure, remedial action taken to correct a given varianceshall be undertaken and documented.

4.5 OQ ProcedureDescribe the OQ procedure.

Example:

. Identify all operational SOPs that are in place or that need to be developed.

. Test modules may be listed together or each test module may be given a newnumber. State whether the modules are to be performed in order or whether theycan be performed in any order.

. Perform each test module as described. Enter the data m the spaces provided.

4.6 Verification of SOPsDefine SOPs needed to properly operate the instniment/equipment. Note: These shouldbe approved, or at a mmimum drafted, before the qualification can be approved.

Table 4.1SOPH Title Verified



4.7

Table 4.2

Test Modules

List and verify that all required materials/instruments/equipment are present.

Material/Instrument/

Equipment

Manufacturer Model Number/

CatalogueNumber

SerialNumber/Loi

Number

ExpirationDate

NISTCertification

Number

VerifiedBy

4. 7. 1. 1 Procedure for the Test Module

Provide details of test module procedure. Write test procedures for generalverification that engineering safety controls are working properly, test basicoperating functionality critical to its intended use, and verify equipment settingsprodiice reproducible results. Verify any required PPE is available andapplicable as indicated.

4. 7. 1.2 Results of Test

Record results of the test and initials of persons verifying and checking theresults. What mode the instniment/equipment will be left in behveen the differenttime intervals should be stated.

4. 7. 1.3 Data Analysis

Provide a brief description of the data analysis methodologies to be used.

Example:Determine the Standard Deviation of the test points to the known weights.Calculations may be performed on separate sheets and appended to thisdocument or written into the module.



5. PERFORMANCE QUALIFICATION (PQ)

5.1 Scope and ResponsibilityInsert information about scope, such as the test procedures and acceptance criteriaspecific to this qualification. Identify who will be completing the work and describerequired pre-validation training including who will be conducting the framing, ifapplicable.

5.2 Reference(s)List any reference standards used for PQ of the instrumeiit/equipment.

5.3 Documentation

List SOPs, attachments, or operator 's manuals needed for PQ.

5.4 Test Module Acceptance CriteriaList test module acceptance criteria.

Example:

. All test modules must be performed according to the procedure included in eachtest module.

. Faihire of any or all of the replicate data sets to meet acceptance criteria -willconstitute a trial failure. If a root cause can be found for one trial failure, thesingle trial is repeated under the corrected condition and with the approval ofQSU. If no root cause is found, all replicates must be repeated.

. In the event of a trial failure, remedial action taken to correct a given varianceshall be undertaken.

5.5

5.6

PQ ProcedureProvide details of the PQ procedure.

Example:

. Verify all operational SOPs are approved and in place.

. Test modules may be listed together or each test module may be given a newnumber.

. Perform each test module as described. Enter the data in the spaces provided.

. Complete the PQ Summary Section. The Siipei-visor/Manager is responsible forreviewing this report.

Verification of SOPsList SOPs needed to properly operate the instrument/equipment. Note: These should beapproved, or at a minimum drafted, before the qualification can be approved.

Table 5.1SOP # Title Verified



5.7 Test Modules

Verify that all required materials/instrwnents/equipment are present.

Table 5.2Material/

Instrument/

Equipment

Manufacturer Model Number/

CatalogueNumber

SerialNumber/Loi

Number

ExpirationDate

NISTCertification

Number

VerifiedBy

5.7. 1. 1 Procedure for the Test Module

Provide details of the test and initials of persons verifying and checking theresults. State what mode the equipment will be left in between the different timeintervals.

5. 7. 1.2 Results

Record results of the test and initials of persons verifying and checking theresults.

5. 7. 1.3 Data AnalysisProvide a brief description of the data analysis methodologies to be used.

Example:

Determine the Standard Deviation of the test points to the known weights.Calculations may be performed on separate sheets and appended to thisdocument or written into the module.

6. Amendment Revision History (as applicable)Provide a brief description of the change(s) from the previous review and approval. Includejustification for the change (s}.

COMM-QA-044 FRM1 Instrument Equipment Validation ProtocolOffice of Regulatory Affairs and Quality, Duke UniversityDurham, NC PagelOofll


7. Final Protocol Summary ReportA final summary report should be generated after execution of the protocol. The final report -willinchtde completed tables with data and other information as described in the protocol. Inaddition, summaries, conclusions, and recommendations should also be included. Deviations

fi'om the protocol should be noted in the final report, including an assessment/justification of anyperceived impact to the qualification of this instrument.

COMM-QA-044 FRM1 Instalment Equipment Validation ProtocolOffice of Regulatory Affairs and Quality, Duke UniversityDurham, NC Page 11 ofl 1


Signature Manifest

Document Number: COMM-QA-044 FRM1

Title: Instrument Equipment Validation Protocol FRM1

Revision: 04

All dates and times are in Eastern Time.

COMM-QA-044 FRM1 Instrument Equipment Validation Protocol FRM1

Author

Name/Signature

Lisa Eddinger (LE42)

Medical Director

Name/Signature

Joanne Kurtzberg(KURTZ001)

Quality

Name/Signature

Richard Bryant (RB232)

Document Release

Name/Signature

Title

Title

Title

Title

Date

12 Jul 2019, 05:44:17 PM

Date

12 Jul 2019, 06:42:40 PM

Date

15 Jul 2019, 07:32:58 AM

Date

Meaning/Reason

Approved

Meaning/Reason

Approved

Meaning/Reason

Approved

Meaning/Reason

Sandy Mulligan (MULL1026) 15 Jul 2019, 02:29:45 PM Approved


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DUKE - EMMESspitfire.emmes.com/study/duke/SOP/Common Quality...Installation Checklist for Environmental and Utilities Requirements List utilities necessaiy to properly operate the