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Validation: an introduction to IQ , OQ and PQ .

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Validation: an introduction to IQ , OQ and PQ .

Validation: an introduction to IQ, OQ and PQ. This seminar teaches the basics of validation. It is designed for people who have no experience in validation.

http://www.vcillc.com/training/Class.Outline-Validation.an.introduction.to.IQ.OQ.and.PQ.pdf

Date added: March 2, 2012 - Views: 307

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ABC LABORATORIES - Elsmar

IQ/OQ/PQ Protocol March 23, 2004 Page 1 of 42 ABC LABORATORIES Lunaire Environmental Chamber Model # CEO932W-4 Serial # 25647-07 ... protocols. f Execution of this protocol. f Preparation of the Final Report. 2.6.2 ABC Laboratories:

http://elsmar.com/pdf_files/IQ_OQ_PQ_protocol_sample.pdf

Date added: April 27, 2012 - Views: 44

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FDA Guidance for Industry Update - Process Validation

The changing face of Validation; are IQ, OQ and PQ really dead and buried?really dead and buried? In November 2008, the FDA released a draft version of its long-awaited update to its Process Validation Guidance for Industry.

http://www.pharmout.net/downloads/white_paper_fda_process_validation_guidance_update.pdf

Date added: November 23, 2012 - Views: 101

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IQ/OQ/PQ - CfPA

IQ/OQ/PQ 10±11 March 2014 · Amsterdam, The Netherlands | Offering# 1403-203 The Center for Professional Advancement 2014 COURSE OUTLINE www.cfpa.com

http://www.cfpa.com/pdf/2014/1808,F,1403-203.pdf

Date added: October 25, 2013 - Views: 22

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Validation: an introduction to IQ, OQ and PQ.

Validation: an introduction to IQ, OQ and PQ. This seminar teaches the basics of validation. The participants will learn how to write practical protocols

http://www.vcillc.com/sites/vcillc.com/files/pdf/Class.Outline-Validation.an.introduction.to.IQ.OQ.and.PQ.pdf

Date added: January 10, 2014 - Views: 9

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IQ/OQ/PQ

IQ/OQ/PQ 18±19 February 2013 · Amsterdam, The Netherlands Dr./Mr./Ms. Job Title Company/Organization Department/Mail Code Mailing Address Fax: ... • Prepare IQ/OQ/PQ Protocols and Verification Protocols • Perform execution of approved protocols

http://www.cfpa.com/PDF/2013/1808,C2-128,1302-402.pdf

Date added: May 27, 2013 - Views: 25

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IQ, OQ, PQ Qualification Seminar Presentation - Home - Mangan

IQ, OQ, PQ Qualification Seminar Presentation Derry, New Hampshire. April 2, 2013 ... “Our ability to successfully execute qualification protocols, proving that our client’s HVAC systems and procedures met or exceeded FDA expectations is

http://www.eastcoastvalidation.com/news/ECVS-PR-4-2-13.pdf

Date added: June 5, 2013 - Views: 18

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REQUIREMENTS FOR COMPUTER SYSTEM REQUIREMENTS, VALIDATION ...

reports, including the validation plan for a system, the IQ, OQ and PQ validation protocols, protocol reports and the Validation Final Report as required by VAL002 or VAL003. 2. SCOPE This procedure applies to all computer system validation plans, protocols (IQ, OQ, or PQ),

http://www.complianceonline.com/images/supportpages/501056/sample_VAL004%20Req%20for%20val%20plans%20%20protocols%207%20Mar%2006.pdf

Date added: May 25, 2012 - Views: 48

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A WHO guide to good manufacturing practice (GMP) requirements

GMP covers all aspects of the manufacturing process: defined manufacturing process; validated critical manufacturing steps; ... examples of IQ, OQ, and PQ protocols. 11.1 System: heating, ventilation, air conditioning (HVAC) IQ, OQ, PQ. HVAC IQ.

http://whqlibdoc.who.int/hq/1997/WHO_VSQ_97.02.pdf

Date added: December 19, 2011 - Views: 245

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autoclave iq oq pq

Secure Software and IQ/OQ/PQ validation protocols. AUTOCLAVE ... • IQ/OQ/PQ/DQ certificates • CE Marked Certificate • ISO-9001 : 2000 Certificate. Powered by TCPDF (www.tcpdf.org) 2 / 2. http://www.consteril.com/wp-content/uploads/2013/08/SterilQ_techsheet.pdf.

http://www.pdfspath.com/download/autoclave%20iq%20oq%20pq.pdf

Date added: August 6, 2014 - Views: 1

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Thermo Scientific Validation Services for Laboratory Equipment

Improved Productivity Our factory-developed IQ, OQ, PQ protocols allow you to start the review process before the equipment arrives, increasing product uptime.

http://labequipmentparts.com/support/documents/BRSERVALID1010.pdf

Date added: October 26, 2012 - Views: 19

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MicroBio MB1 IQ/OQ/PQ - Cantium Scientific

MicroBio MB1 IQ/OQ/PQ Installation, Operational and Performance Qualification Protocol and Report for the MicroBio MB1 Bioaerosol Sampler Document No:

http://www.cantiumscientific.com/downloads/P0001W004.pdf

Date added: April 10, 2012 - Views: 15

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Business Performance Document #: VAL015 ECO #: Associates ...

The purpose of this procedure is to provide guidance on what to test in IQ, OQ, and PQ protocols for computer systems. This procedure is a guidance document and is not binding. 2. ... Microsoft Word - VAL015 Guidance items for IQ OQ PQ 23 June 06.doc

http://www.complianceonline.com/images/supportpages/501091/sample_VAL015%20Guidance%20items%20for%20IQ%20OQ%20PQ%2023%20June%2006.pdf

Date added: April 23, 2012 - Views: 29

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Pharmaceutical Cleanroom Commissioning, Certification, and ...

DQ, IQ, OQ, and PQ Pharmaceutical Cleanroom Commissioning, Certification, and Validation DQ, IQ, OQ, and PQ April 2005 Presented by ... Cleanroom Operation Protocols for Cleanroom Operations Executed in Parallel with During Commissioning – Testing, Balancing, Certification

http://www.gmpua.com/CleanRoom/Design/CleanroomQualification.pdf

Date added: December 18, 2011 - Views: 277

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EQUIPMENT QUALIFICATION PLAN (EQP) - Agilent Technologies

It covers Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), scheduled repeat OQ, and Re ... protocols, calculates results ... Policy documents dictate the need for validation & qualification of GMP/GLP systems and usually mention the DQ/IQ/OQ/ PQ ...

http://www.chem.agilent.com/Library/service/Public/Review%20Document_Standard_EQP_GC.pdf

Date added: April 10, 2012 - Views: 23

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Process Validation 101 - DIGICOM Electronics

Process Validation 101 by Anne Bynon, MSBE and Fariba Hurry, MS 3 What is a PQ? The PQ demonstrates that the process consistently produces acceptable product.

http://www.digicom.org/Electronics-Manufacturing-Services-EMS-Process-Validation-101.pdf

Date added: October 26, 2012 - Views: 35

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Guidelines for Validation &Qualification, including Change ...

Validation protocols should be written for each phase of the validation to include acceptance criteria. The validation plan and the ... (IQ,OQ,PQ or method process validation) that tests will be performed the test procedures

http://www.bcshguidelines.com/documents/Guidelines_for_validation_bcsh_13082010.pdf

Date added: February 13, 2012 - Views: 123

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V1 Validation Protocols & On-Site Validation Services 29 03 11

Validation Protocols & On-Site Validation Services Rely on a comprehensive and ready to use validation. Validation Protocols consist of the following test sections:

http://labface.com/suppliers/pdf/milliporevalidationpdf.pdf

Date added: May 6, 2013 - Views: 92

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RevereIT LLC

examples of IQ, OQ, and PQ protocols 11.1 System: heating, ventilation, air conditioning (HVAC) IQ, OQ, PQ . 11.2 Large equipment: Autoclave IQ, OQ, PQ . ... validation protocols usually indicates a lack of documentation, and often data is reported as only

http://revereit.com/pdf/RevereIT%20-%20Validation%20-%20An%20Introduction.pdf

Date added: November 13, 2012 - Views: 14

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Steril-Q - Consolidated Sterilizer Systems

Made in USA Steril-Q™ IQ/OQ/PQ Validation Services Steril-Q™ Validation and Documentation Services Steril-Q™ includes an array of documentation, tools and

http://www.consteril.com/wp-content/uploads/2013/08/SterilQ_techsheet.pdf

Date added: October 24, 2013 - Views: 7

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EQUIPMENT QUALIFICATION PLAN (EQP) - Agilent Technologies

This document is an Equipment Qualification Plan (EQP). It covers Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), ... protocols, calculates results and ... PQ model. The precise procedures for IQ & OQ for each type of equipment are prescribed in an ...

http://www.chem.agilent.com/Library/service/Public/Review%20Document_Standard_EQP_LC.pdf

Date added: March 7, 2012 - Views: 35

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Installation Qualification/Operational Qualification ...

Installation Qualification/Operational Qualification Protocols and Instructions Experion™ Automated Electrophoresis Station and Software Validation Kit

http://www.bio-rad.com/webroot/web/pdf/lsr/literature/10005250C.PDF

Date added: December 16, 2011 - Views: 130

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MicroBio MB2 IQ/OQ/PQ - Cantium Scientific

MicroBio MB2 IQ/OQ/PQ Installation, Operational and Performance Qualification Protocol and Report for the MicroBio MB2 Bioaerosol Sampler Document No:

http://www.cantiumscientific.com/downloads/P0002W002.pdf

Date added: May 24, 2012 - Views: 7

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USP < 1058 > AIQ Risk-Based Instrument Qualification Guidelines

• DQ / IQ / OQ / PQ Risk Management: Grouping Instruments into A / B / C categories ... Performance Qualification Ongoing ... environment can be achieved by employing uniform protocols for

http://labcompliancesolutions.com/wp-content/uploads/2011/09/USP-1058-AIQ-Risk-Based-Instrument-Qualification-Guidelines.pdf

Date added: February 29, 2012 - Views: 242

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ULT90 - Instrumart

CFR Part 11 Secure Software and IQ/OQ/PQ validation protocols. For larger freezers, loggers can be plotted in one graph to show variances in different parts of the freezer. Finally, as failure to monitor external

http://www.instrumart.com/assets/ult90-Datasheet.pdf

Date added: May 6, 2013 - Views: 4

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Complete and Efficient Process Validation - FINAL

• Validation Protocols and Reports −Are there thorough validation reports? ... • Review Facility and Systems Validation −IQ/OQ/PQ reports for equipment −Validation of critical process utilities −EIRs– last three years – look for validation issues

http://www.bptc.com/sites/default/files/presentations/complete.pdf

Date added: October 14, 2012 - Views: 13

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Pharmaceutical Regulation Impact When a client was required ...

Installation Qualification (IQ)-Documents ... important part of regulatory compliance. This qualification process is now used for Wintel, UNIX, Linux and VMS environments to ensure ... Microsoft Word - CS Pharma IQ-OQ-PQ development.doc

http://www.courtsquaregroup.com/pdf/case_studies/CS%20Pharma%20IQ-OQ-PQ%20development.pdf

Date added: June 5, 2013 - Views: 6

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ContinuousCustomer Support - PerkinElmer

PerkinElmer understands the traceability requirements of quality measuring devices and ensures that: ... • Consistent IQ, OQ, PQ protocols designed to fit your laboratory needs • Integrated solutions designed to reduce compliance risk

http://shop.perkinelmer.com/Content/onesource/Multi-vendor%20Validation%20Brochure.pdf

Date added: May 11, 2012 - Views: 10

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Validation and Qualification - Infitrak

documenting the procedures and protocols that demonstrate your equipment and processes operate within acceptable parameters. Validation and ... • IQ/OQ/PQ results and findings • Calibration parameters for any equipment used in the qualification testing

http://www.infitrak.com/wp-content/uploads/2012/05/Validation_and_Qualification1.pdf

Date added: March 31, 2014 - Views: 1

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Product/Process Validation (PHSC 338) - Campbell University

IQ/OQ and PQ Protocols Validation Projects: Overview of IQ/OQ and PQ; Discuss Content of IQ/OQ and PQ Protocols (continued) Prepare for Validation Project Execution 4 Apr Through 7 Apr Validation Project: Execute IQ/OQ and/or PQ Protocol

http://web.campbell.edu/faculty/fetterman/PHSC%20338/Process%20and%20Product%20Validation%20Course%20Schedule%20Spring%202005.pdf

Date added: May 6, 2013 - Views: 12

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Reasons, Regulations, and Rules: A Guide to the Validation ...

proposed Qualification tests (IQ/OQ/PQ) should be identified ... protocols. The VMP needs to be updated to document major project scope changes such as the addition or deletion of equipment, and project completion (i.e., release to production).

http://systemworksit.com/wdynamics/site/client_data/55/filedrop/uploads/01MJ-Saxton.pdf

Date added: August 13, 2013 - Views: 2

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PROJECT AND VALIDATION SERVICES

Barry-Wehmiller Design Groupcan assist you with your complete validation needs. From specifications and master plans to FAT and IQ/OQ protocols, process validation,

http://www.barry-wehmiller.com/literature/BarryWehmillerDe/EngineeringConsu/validlr_728.pdf

Date added: October 25, 2013 - Views: 3

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Ultra Low Freezer Temperature Validation System

Software and IQ/OQ/PQ validation protocols. For larger freezers, loggers can be plotted in one graph to show variances in different parts of the freezer. Finally, as failure to monitor external freezer temperatures may invalidate internal freezer temperatures, an

http://www.omega.com/DAS/pdf/OM-CP-ULT90.pdf

Date added: February 28, 2012 - Views: 25

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FDA Validation Protocols and Services for QAD

FDA Validation Protocols and Services for QAD ... (IQ) Protocols Operational Qualification (OQ) Protocols Performance Qualification (PQ) Protocols Software Validation Master Plan (SVMP) Development 21 CFR Part 11 Compliance Services

http://www.strategic.com/products/download/qad-fda-validation-protocols-and-services/

Date added: May 6, 2013 - Views: 6

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V VAALLIIDDAATTIIOONN GGUUIIDDEE - Packworld USA

Process Qualification - (See Appendix One) ... Process validation is considered to be a total process that includes written protocols, ... The validation system employs IQ, OQ and PQ as described above and combines these

http://packworldusa.com/pdf/Packworld_Validation_Guide.pdf

Date added: April 17, 2012 - Views: 1

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Process Validation of Solid Oral Dosage Forms, Part I General ...

Prospective Process Validation Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Protocol Approval PQ Protocol Execution Data Analysis ... General Notes on Validation - #4 • Following protocols and procedures is another

http://www.ikev.org/haber/bozzonejune1.pdf

Date added: December 21, 2011 - Views: 261

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DISSOLUTION TEST SYSTEM VALIDATION LOGBOOK

Performance Qualification of the DISTEK Dissolution Test System Unit. ... I agree that the IQ, the OQ and the PQ procedures in this document, assembled by DISTEK, München ... Attach protocols. LEFT BLANK. Version 20020416 REV 4 Printing Date: ...

http://www.diessechem.com/download.php?file=1296231549-IQOQDIss_Copy.pdf

Date added: June 9, 2013 - Views: 9

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COMMISSIONING - Maetrics

Executed commissioning, qualification, and validation programs, including: Process validation Facility commissioning ... Developed and executed equipment qualification protocols (IQ, OQ, PQ), SOPs, and final reports for various process

http://www.maetrics.com/documents/Case%20Studies/Commissioning_Case_Study.pdf

Date added: April 23, 2013 - Views: 10

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Product/Process Validation (PHSC 338) - Campbell

(VPM), validation protocols (DQ, IQ, OQ, PQ), validation summary report (VSR). Basics of a Validation Master Plan (VMP) Validation Master Plan ... Discuss Content of IQ/OQ and PQ Protocols Protocol Assignment . 16 Jan 04 Rev 0 Product/Process Validation (PHSC 338)

http://web.campbell.edu/faculty/fetterman/PHSC%20338/Process%20and%20Product%20Validation%20Schedule%20Spring%202004.pdf

Date added: March 11, 2013 - Views: 16

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hvac validation protocols

7.4 Verification protocols: The Verifier shall verify an HVAC system installation in two stages: review of the installation file and the in-field verification. ... Certification, and Validation DQ, IQ, OQ, and PQ Pharmaceutical Cleanroom.

http://www.pdfspath.com/download/hvac%20validation%20protocols.pdf

Date added: July 31, 2014 - Views: 2

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Product Specifications UV Validator Qualification ...

for Thermo Scientific UV-Visible spectropho-tometers, ... (OQ), Performance Qualification (PQ) and Re-Qualification (RQ) procedures for simple ... IQ/OQ When purchased with both the UV Validator and Installation Certification Service,

http://www.thermo.com/eThermo/CMA/PDFs/Product/productPDF_51149.pdf

Date added: October 13, 2012 - Views: 7

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VAL-005 Validation-Concept and Procedure - Gmpsop

A Validation Plan 4. Installation Qualification Report/s 5. A series of Operational Qualification Test Protocols and Raw Data Results (as defined in the Validation Plan. 6. ... All DQ, IQ, OQ and PQ Protocols shall define the acceptance criteria with

http://www.gmpsop.com/sample/VAL-005_Validation-Concept_and_Procedure_sample.pdf

Date added: November 2, 2012 - Views: 10

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A Comparison of the FDA’s Draft Process Validation Guidance ...

process validation guidance. A Comparison of the FDA’s Draft ... IQ, OQ, and PQ,” the following is suggested with . ... • These checklists that are labeled IQ/OQ protocols also could

http://www.commissioningagents.com/clientuploads/directory/Documents/09mj-chew.pdf

Date added: October 7, 2011 - Views: 234

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SERVICE AND QUALITY - Caron Products

The validation services are performed according to IQ, OQ and PQ protocols. Caron’s validation services satisfy FDA guidelines for ... • Validation protocols for cGxP requirements. • Protocols can be modified to meet your specific needs.

http://caronproducts.com/lib/sitefiles/pdf/literature/lit_ServiceQuality.pdf

Date added: February 1, 2013 - Views: 2

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Clean Room – HVAC GMP & ISO 14644 Validation Services

 GMP & ISO 14644 Requirements  EN 1822 Test Method  DEHS Test Media  Laser Particle Counter  Calibrated Particle Generator  Calibrated 1:100 Dilution System  Preparation of Test Protocols ... • Submittal of completed IQ, OQ, PQ protocols

http://www.stefatos.gr/client_files/Validation_Leaflet.pdf

Date added: December 30, 2011 - Views: 95

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Professional Installation & Qualification for Meters IPac ...

Qualification documentation Proven IQ/OQ protocols Qualified personnel User training Performance at a constant level Routine tests (PQ) defined ... Performance Qualification is a process of: • regular examination of instrument performance

http://us.mt.com/us/en/home/supportive_content/product_documentation/datasheets/SevenMulti_IPac/jcr:content/download/file/file.res/51725171B_V09.11_IPac_pH_Lab_DB_e_WEB.pdf

Date added: September 5, 2013 - Views: 2

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VALIDATION VMP - İKEV

VMP PROTOCOLS TESTS VALIDATION REPORTS VALIDATION Validation is a documented program that provides high ... CDQ IQ OQ PQ Process Cleaning Areas X Cleaning Equipments X Cleaning Machine Parts X Cleaning Garments X Filling Operation X Vial Washing X Plugging X

http://www.ikev.org/haber/val-mas-pl.pdf

Date added: May 16, 2012 - Views: 15

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NEW! Alltech 3300 ELSD

Alltech® 3300 ELSD sensitive ... Full IQ/OQ/PQ protocols included with each ELSD The 3300 ELSD is easy to integrate into a qualified HPLC system. It is thoroughly tested before shipment and calibration ... IQ/OQ/PQ at Customer Site Q330030 Alltech ...

http://www.bioszeparacio.hu/_user/downloads/Alltech%20keszulekek/M147_3300ELSDlr.pdf

Date added: October 26, 2012 - Views: 5

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21 CFR Part 11 Data Sheet2 - CAS DATALOGGERS

IQ/OQ/PQ protocols can be purchased and implemented to validate Additional support is available for full software training. The layout of the secure software is similar to the Madgetech Standard Software version, allowing users to easily learn the additional features.

http://www.dataloggerinc.com/datasheets/madgetech-21_CFR_Part_11_Data_Sheet.pdf

Date added: May 6, 2013 - Views: 7

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QE SPECIALIST II

• Develop and execute equipment, utility and facility qualification (IQ, OQ, PQ) protocols. • Prepare qualification (IQ, OQ, PQ) reports. • Develop and execute factory acceptance test at OEM facilities as required.

http://www.avevadds.com/WEB_QE%20Specialist_Aug2012.pdf

Date added: February 20, 2013 - Views: 1