August 25, 2017 — Latest Information VrrP & 4G Protocol.
May 12, 2017 — Latest Information VrrP & 4G Protocol.
May 01, 2017 — Introduction of VrrP & 4G Protocol.
September 22, 2016 — HVAC HEPA Essential Corrections.
September 12, 2016 — HVAC HEPA Essential Corrections.
September 07, 2016 — FDA Citations and SOP's.
August 01, 2015 — FDA COMPLIANT CALIBRATION.
August 01, 2015 — FDA COMPLIANT CALIBRATION.
May 31, 2015 — FDA Citations and SOP's.
May 29, 2015 — FDA and Design Qualification.
November 26, 2014 — FDA COMPLIANT CALIBRATION.
July 10, 2014 — Validation Risk Assessment (VRA).
June 04, 2014 — Transgressions & Citations.
April 16, 2014 — Cold Chain Compliance.
February 02, 2014 — GMP Importance of Procurement
September 03, 2013 — Serious Product Contimination.
September 02, 2013 — Latest Issue Protocols.
August 21, 2013 — Validation Document Packages
August 16, 2013 — Validation Risk Assessment.
July 18, 2013 — FDA Inspection Issues.
April 09, 2013 — FDA and Quality Steam Testing.
December 11, 2012 — Machinery Validation Package.
November 30, 2012 — Laboratory Validation Package.
October 31, 2012 — GMP Transgressions and Citations.
September 17, 2012 — Validation Risk Assessment.
August 22, 2012 — Laboratory Equipment Validation.
August 15, 2012 — Software Validation.
July 25, 2012 — Proper use of the DQ.
July 02, 2012 — Employee Appraisal.
May 23, 2012 — Keeping Cold Rooms Cold.
May 22, 2012 — Warehouse Climatic Validation.
March 14, 2012 — New e-mail Address.
March 11, 2012 — Climate Controlled Cabinets
February 28, 2012 — Validation Of Temperature Controlled Cabinets & Rooms
February 22, 2012 — GMP Work Experience Assessment
January 23, 2012 — Quality Steam Qualification.
December 14, 2011 — FDA Audit Documentation.
November 28, 2011 — Radio and Magnetic Interference.
November 24, 2011 — Quality System Regulation.
August 26, 2011 — Procurement Citations.
August 25, 2011 — Software Validation.
July 20, 2011 — FDA Contentious GMP Topics.
April 06, 2011 — Regulatory Warning Letters.
March 16, 2011 — Whistle Blowers.
March 15, 2011 — Whistle Blowers.
February 16, 2011 — FDA Ruling Autoclaves.
January 10, 2011 — Validation Points Of Contention. Point 4.
December 09, 2010 — GMP Violations and Citations.
November 29, 2010 — Validation & Sub-Contracting Companies.
November 11, 2010 — FDA and Personal Accountability.
November 02, 2010 — FDA Important Procedures.
September 30, 2010 — Regulatory Compliance (483's).
September 28, 2010 — Software Validation.
August 06, 2010 — Software Validation.
July 27, 2010 — Consultant Responsibilities.
June 14, 2010 — The Trials & Tribulations of Spreadsheets
May 17, 2010 — 21 CFR Part 11 Guidance Document.
May 06, 2010 — 21 CFR Part 11 Guidance Document.
March 22, 2010 — 21 CFR Part 11 Guidance Document.
February 23, 2010 — 21 CFR Part 11 Guidance Document.
February 04, 2010 — Combined IQ/OQ Protocol.
January 26, 2010 — Combined IQ/OQ Protocol.
December 21, 2009 — HUMIDITY CALIBRATION.
November 30, 2009 — HUMIDITY CALIBRATION.
October 27, 2009 — THE EVOLUTION OF 21 CFR PART 11.
October 06, 2009 — THE EVOLUTION OF 21 CFR PART 11.
September 10, 2009 — VLIDATION COSTS
July 23, 2009 — FMEA for Bio-Med.
June 02, 2009 — FMEA for Bio-Med.
April 20, 2009 — FDA COMPLIANCE
March 09, 2009 — FDA COMPLIANCE
February 12, 2009 — FDA COMPLIANCE
February 12, 2009 — FDA COMPLIANCE
January 26, 2009 — FDA COMPLIANCE
October 14, 2008 — FDA COMPLIANCE
September 09, 2008 — FDA COMPLIANCE
July 04, 2008 — FDA COMPLIANCE
May 04, 2008 — FDA COMPLIANCE
March 11, 2008 — FDA COMPLIANCE
February 11, 2008 — FDA COMPLIANCE
November 19, 2007 — FDA COMPLIANCE
November 07, 2007 — FDA COMPLIANCE
October 11, 2007 — FDA COMPLIANCE
June 19, 2007 — New Release.
May 14, 2007 — New Site Documentation.
March 29, 2007 — MHRA & FDA Fridges and Pure Steam
February 01, 2007 — Compliance Group, Issue #001 -- teaser here
Urgent Requirement
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Index Page
Autoclave Validation
CAPA - GMP
Cold Chain Validation
Computer Compliance annex 11
Corporate Quality Manual
Computer Qualification
Computer System Validation
Computer Vender Audit
Corporate Validation Manual
Cost Effective Validation
Dental Validation
Design Qualification
Equipment Qualification
Facilities Qualification
Facility Pure Steam
FAT & SAT
FDA Failure Analysis
Free Downloads
GAMP 5
Good Manufacturing Practice (cGMP)
Facilities HVAC
HVAC Qualification
Installation Qualification
Installation Validation
IQ OQ PQ Template
Lab Validation Package
LAN Validation
Machinery Qualification
Medical Device Templates
Machinery Validation
Online Validation
Operational Qualification
Operation Validation
21-CFR-Part-11
Part 11 update
Performance Qualification
Pharmaceutical Equip Validation
Pharmaceutical Validation
PLC Qualification
Process Qualification
Process Validation
Regulatory Compliance
Risk Based Validation
Site Based Reporting
Software Qualification
Software Validation
Spreadsheet Validation
Standard Operating Procedure
System Hardware Validation
System Process Air
Temperature Safe Transit
UDI Time Schedules
URS
Validation Academy
Validation Executables
Validation Master Plan
Validation Online Newspaper
Validation Online Stats
Validation Plan
Validation Protocol Standards
Validation Quality Plan
Validation Risk Assessment
Validation Templates
Validation 4U
Validation4U
Warehouse Climatic Mapping
Standard Operating Procedures
(SOP's)
SOP for: Vendor Audit Check.
SOP for: GMP.
SOP for: cGMP review.
SOP for: Retrospective Validation.
SOP for: PPP Compliance.
SOP for: Compliance 21 CFR Part 11.
SOP for: 21 CFR Part 211.
SOP for: Sensor Calibration.
SOP for: GAP Analysis.
SOP for: Document Matrix.
SOP for: Predite Rules.
SOP for: Vendor audit.
ValidationOnline Blog
News for Today
All documents are now available in any language. Simply, when you make a purchase; you will be issued with an order number. Email us this order number and the language required, and we will then translate the documents listed in your purchase order into the language you have chosen, and email them out to you. No extra charge.
To ensure your protocols are going to be cGMP compliant always ensure that the templates you use; are technically fully detailed, and use a comprehensive and interactive lead-through SOP.
Complex equipment will always require a full suite of protocols; however simple equipment can often be validated with a more basic combination iq/oq/pq template: Your Risk Assessment must define this requirement.
If assistance is required in selecting the appropriate documents then please make contact with us at email address: rc@validation-online.net (all lower case) and we will contact you. for urgent requirements ring direct +44 1842 820906.
Complete validation Equip/HVAC/Com/soft/Util/Steam Packages VMP/VRA/URS/DQ/IQ/OQ/PQ from $199.00
The ever popular Combination IQ/OQ/PQ FOR $199.00
The only one on the net - Steam Qualification package $199.00
These templates cut Authoring costs - 50/75% Reviewing time - 50% and execution costs 20/40%.
The only interactive and fully detailed suit of protocols available on line for Autoclave and Steam cGMP validation.VP/URS/IQ/OQ/PQ Complete with integral LEAD-ME-THRU' SOP.
The only cGMP compliant Risk Assessment Template available on line.