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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: 309

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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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IQ/OQ/PQ - CfPA

IQ/OQ/PQ 10±11 March 2014 · 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/2014/1808,F,1403-203.pdf

Date added: October 25, 2013 - Views: 22

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FDA Guidance for Industry Update - Process Validation

Process Validation: General Principles and Practices”. This document, issued for public comment, ... mean that equipment IQ, OQ and PQ are no longer required? The answer is both yes and no! Yes, in that there is no expectation expressed in the

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

Date added: November 23, 2012 - Views: 103

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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: 11

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Qualifications (IQ/OQ/PQ)

Qualifications (IQ/OQ/PQ) An innovative, multi-platform, harmonized analytical instrumentation qualification service for the makes and models of chemical analysis systems we service.

http://theoverbrookgroup.com/wp-content/uploads/2013/09/OSS_Qualifications-data-sheet.pdf

Date added: December 6, 2013 - Views: 10

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IQ/OQ/PQ - CfPA

IQ/OQ/PQ 18±19 February 2013 · Amsterdam, The Netherlands Dr./Mr./Ms. Job Title Company/Organization Department/Mail Code Mailing Address Fax: E-mail Address How did you learn about this cour Surname Given Name Postal Code Priority Code:

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

Date added: May 27, 2013 - Views: 28

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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: 247

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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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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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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. SCOPE This document applies to computer systems using off-the-shelf, ...

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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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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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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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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Process Validation 101 - DIGICOM Electronics

This plan identifies the three IQ, OQ and PQ protocols and includes the acceptance criteria that each of these must meet their ... implement the process validation protocols. About the Authors Anne Bynon is an independent consultant with over 20 years of

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

Date added: October 26, 2012 - Views: 35

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Installation Qualification/Operational Qualification ...

Bio-Rad Laboratories recommends that the IQ/OQ protocols be performed in total when the Experion automated electrophoresis station and software are initially installed. Installation qualification should also be performed when the Experion electrophoresis station is moved to a

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

Date added: December 16, 2011 - Views: 131

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RevereIT LLC

RevereIT LLC Validation – A Brief Introduction Version: 1.32 . ... The IQ, OQ and PQ must be performed in order: ... examples of IQ, OQ, and PQ protocols 11.1 System: heating, ventilation, air conditioning (HVAC) IQ, OQ, PQ .

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

Date added: November 13, 2012 - Views: 14

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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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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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Complete and Efficient Process Validation - FINAL

IQ/OQ/PQ reports for equipment −Validation of critical process utilities −EIRs– last three years – look for validation issues −Change Control procedures and policies. ... ¾Outline process validation protocols required including:

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

Date added: October 14, 2012 - Views: 13

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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: 10

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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 Flexibility in determining what is done in OQ and PQ Major Areas of USP <1058> AIQ Analytical Instrument ... and consistent protocols for all similar instruments - no matter the manufacturer.

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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ContinuousCustomer Support - PerkinElmer

• Consistent IQ, OQ, PQ protocols designed to fit your laboratory needs • Integrated solutions designed to reduce compliance risk Expert Multi-Vendor Validation support and consultancy, working with you to improve compliance, reduce risk and save money.

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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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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Pharmaceutical Regulation Impact When a client was required ...

• Design Qualification (DQ)- Protocols and specifications outlining minimum requirements for unique configurations of system hardware, software and ancillary software tools. ... Microsoft Word - CS Pharma IQ-OQ-PQ development.doc Author:

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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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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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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PROJECT AND VALIDATION SERVICES - Barry-Wehmiller

IQ/OQ protocols validation master planning PQ services PROJECT AND VALIDATION SERVICES Like to Learn More? Please contact: Glenn Barbrey Barry-Wehmiller Design Group, Inc. 225 Spartangreen Boulevard Duncan, SC 29334 USA Phone: (864) 486-4300

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

Date added: October 25, 2013 - Views: 3

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FDA Validation Protocols and Services for QAD

The Installation Qualification (IQ) Protocols, the Operational Qualification (OQ) Protocols and the Performance Qualification (PQ) Protocols will provide documented verification ... (PQ) Protocols Software Validation Master Plan (SVMP) Development

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

Date added: May 6, 2013 - Views: 6

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Product/Process Validation (PHSC 338) - Campbell University

Product/Process Validation (PHSC 338) Lecture Schedule Spring Semester 2004 ... (VPM), validation protocols (DQ, IQ, OQ, PQ), validation summary report (VSR). Basics of a Validation Master Plan (VMP) Validation Master Plan Assignment 13 Feb George Waterhouse

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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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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DISSOLUTION TEST SYSTEM VALIDATION LOGBOOK

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: 12 May 2005 Page 13 of 35 DISTEK Dissolution Test System Validation Logbook Unit SN:

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

Date added: June 9, 2013 - Views: 9

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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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Ultra Low Freezer Temperature Validation System

temperature freezer validation system can measure and log data as low as -86°C (-122°F). It can be ... Software and IQ/OQ/PQ validation protocols. For larger freezers, loggers can be plotted in one graph to show variances in different parts

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

Date added: February 28, 2012 - Views: 25

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

IQ/OQ/PQ per se. The EU GMPs prescribe content of IQ, OQ, and PQ with IQ having the most prescriptive detail. The FDA ... • These checklists that are labeled IQ/OQ protocols also could be used as the final verification report and the approval .

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

Date added: October 7, 2011 - Views: 234

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

The Validation Master Plan Reasons, Regulations, and Rules: ... (IQ/OQ/PQ) should be identified with a brief description of the procedure and how the associ- ... Protocols,” which can be used to gauge the man-hour require-

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

Date added: August 13, 2013 - Views: 5

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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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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 qualification verification of equipment. Full on-site and factory calibration services are offered.

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

Date added: February 1, 2013 - Views: 2

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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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NEW! Alltech 3300 ELSD

NEW! Alltech ® 3300 ELSD sensitive ... Full IQ/OQ/PQ protocols included with each ELSD ... Detailed IQ/OQ/PQ procedures are included with the detector to help you perform your own qualification or one of our service engineers can do it for you. Alltech 3300 ELSD*

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

Date added: October 26, 2012 - Views: 5

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PHARMA JOBS SERVICES, CORP

qualification, operational qualification (IQ/OQ) and performance qualification (PQ) protocols and final reports (includes processing equipment and utilities)

http://www.uprm.edu/students/empleos/pharmajob.pdf

Date added: August 6, 2013 - Views: 2

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Best Practices for Qualification Success: A Statistical ...

executed separate IQ/OQ protocols for process equipment ... overlaps with OQ, and all IQ, OQ, and PQ activities provide the basis for process qualification or validation. For the ... As with IQ/OQ duration and IQ/OQ cost, a relationship

http://www.ipaglobal.com/getattachment/4420f9a0-6d4a-4118-a202-b1c058cee8d5/Best-Practices-for-Qualification-Success-(1).aspx

Date added: July 26, 2013 - Views: 2

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VALIDATION VMP - İKEV

PROTOCOLS TESTS VALIDATION REPORTS VALIDATION Validation is a documented program that provides high ... CDQ IQ OQ PQ B uilding B uilding X X X X Services HVAC (Critical system s) X X X X X Industrial Steam (N on - critical ) X X X P ure S team ...

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

Date added: May 16, 2012 - Views: 15

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Methods Development, Validation Procedures and

IQ/OQ/PQ and PM • Validation and Qualification Strategies; Risk Assessment Approach • ICH Q9 • Documentation Strategies; Master Validation Plan and Protocols • Examples of OQ and PQ • HPLC Systems • Dissolution Apparatus • TOC, LC-MS and others • PQ vs. System Suitability

http://www.valqualintl.com/files/METD_and_IQOQPQ_Highlights_4_21_2009.htm

Date added: September 16, 2014 - Views: 1

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21 CFR Part 11 Data Sheet2

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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Validation Services

Iq / Oq /Pq factory acceptance testing ... Customized validation protocols Onsite protocol execution Commissioning of equipment sanyo warranty service coverage. As a leader in commercial, refrigeration, energy and environmental products,

http://us.sanyo.com/dynamic/product/Downloads/Validation_Brochure_2007-38961695.pdf

Date added: August 8, 2013 - Views: 2