Validation Online Compliant Templates.

Any auditor: Regulatory or Routine has the right to review your Risk Based Practice and history.

For some years now we have been working within a (Risk Based) regulatory concession. This concession allows us to assess as to whether software (being validated) is used to integrate two or more parameters; in order to calculate or derive a judgement of cGMP relevance. Or; used to operate items and systems that can be measured or observed. If the latter is identified as the method of use, then routine validation practices acceptable practice; as detailed in Validation Risk Assessment (VRA). If however; the former is shown to be the case; then the software would have to be judged as "Critical" and Full Life Cycle Validation (FLCV) would be mandatory.

This makes the "Validation Risk Assessment" a Super Critical Document.


GET YOUR OWN RISK ASSESSMENT - FOR FURTHER DETAILS

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Oct 01, 2022

Ensure IQ OQ PQ Template is cGMP Compliant

Use our IQ OQ PQ template & follow the integral SOP to edit it into your own bespoke detailed & impressive Protocol.

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Sep 25, 2022

Ensure your Autoclave Validation is cGMP Compliant.

By using our interactive autoclave validation template you can quickly produce an impressive bespoke company protocol.

Continue reading "Ensure your Autoclave Validation is cGMP Compliant."

Sep 24, 2022

21 CFR Part 211 | FDA | MHRA | EU | WHO | GMP |

21 CFR Part 211 defines verification boundaries, mandates validation executables, documents responsibilities, maintains URS traceability & mitigates risk.

Continue reading "21 CFR Part 211 | FDA | MHRA | EU | WHO | GMP | "

Sep 24, 2022

21 CFR Part 11 Implementation - Validation Online.

The intent of 21 CFR Part 11 is to ensure that predicated retention records are held in a format that renders unauthorized editing or deletion impossible.

Continue reading "21 CFR Part 11 Implementation - Validation Online."

Sep 22, 2022

Current Good Manufacturing Practice - Validation Online

Understand Current Good Manufacturing Practice legislation and ensure your; protocols and plans are compliant with it.

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Sep 22, 2022

Edit Software Validation template into comprehensive Protocol.

Learn software validation techniques that automatically produce the tangible evidence that are a prerequisite for success in all software validation projects.

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Sep 22, 2022

Editing your Software Qualification Template into a Protocol.

Edit this software qualification template into a company protocol.

Continue reading "Editing your Software Qualification Template into a Protocol."

Sep 21, 2022

Standard Operating Procedure Template

Standard Operating Procedure template (SOP) are used to precisely replicate specific methodologies that were developed to produce a controlled product.

Continue reading "Standard Operating Procedure Template "

Sep 21, 2022

Pharmaceutical Validation Instant Download Templates.

Learn the simplicity of using Pharmaceutical validation instant download templates.

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Sep 17, 2022

Edit our Operational Qualification Template into your own Protocol.

Simply procure a cGMP compliant Operational Qualification template & follow the integral SOP to edit it into your own cGMP compliant, bespoke & impressive Protocol.

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Sep 16, 2022

Editing Medical Device Validation Template into bespoke Protocol

The Medical Device Validation Template must define & verify; boundaries, responsibilities, executables & requirements for device validation to be successful

Continue reading "Editing Medical Device Validation Template into bespoke Protocol "

Sep 16, 2022

Medical Device Templates | FDA | EC | WHO | cGMP | QbD | GXP | GDP |

Medical Device Templates. FDA, EC, & WHO Compliant. Innovatice and Intuative documentation.

Continue reading "Medical Device Templates | FDA | EC | WHO | cGMP | QbD | GXP | GDP |"

Sep 14, 2022

Facilities HVAC Editing Template into Protocol.

Facilities HVAC validation tasks are greatly simplified when professional templates are used, Simply follow integral SOP and produce your own bespoke protocol.

Continue reading "Facilities HVAC Editing Template into Protocol."

Sep 14, 2022

Pharmaceutical Equipment Validation

Pharmaceutical Equipment Validation made simple; with or without software. Simply follow Interactive completion SOP & edit into cGMP compliant Protocols.

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Sep 08, 2022

Edit our Computer System Validation template into your Protocol.

Follow; Computer System Validation template’s integral SOP and edit template into your own company's bespoke Protocol.

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Sep 07, 2022

Make User Requirements Specification Template into your Doc.

Edit User Requirements Specification template into a bespoke company format

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Sep 06, 2022

Validation Online Stats | Packages | Protocols | Plans | SOP's | Test

Validation Online Statistics are recorded and compiled by independent administrators.

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Sep 06, 2022

Validation executables | FDA | EU | WHO | cGMP | FVLC | SOP's | QbD |

Validation is the verification of a related group of specifications.

Continue reading "Validation executables | FDA | EU | WHO | cGMP | FVLC | SOP's | QbD |"

Sep 06, 2022

Validation A

Validation A is our Interactive cGMP compliant, fully detailed template; then follow the integral completion SOP & proudly sign off, your own bespoke protocol.

Continue reading "Validation A"

Aug 25, 2022

Equipment Qualification cGMP Compliant Protocols.

To produce compliant equipment qualification protocols - use our interactive templates: Follow the integral SOP & edit them into your own impressive protocol.

Continue reading "Equipment Qualification cGMP Compliant Protocols."

Aug 18, 2022

Edit our Process Validation Template into a bespoke Protocol.

Editing our Process Validation template into a bespoke Protocol is accomplished by following the integral completion SOP.

Continue reading "Edit our Process Validation Template into a bespoke Protocol."

Aug 11, 2022

Edit Design Qualification template into Bespoke Protocol

The Design Qualification template must be used in off the shelf purchases to verify operational compliance.

Continue reading "Edit Design Qualification template into Bespoke Protocol"

Aug 10, 2022

Editing Process Qualification template into Protocol.

Process Qualification template used to run batches and check quality. Today the emphasis is on continuous product monitoring. tain products.

Continue reading "Editing Process Qualification template into Protocol. "

Aug 10, 2022

Editing Performance Qualification Template into a Protocol.

Edit this Performance Qualification Template, using the integral SOP to produce your own impressive company bespoke Protocol.

Continue reading "Editing Performance Qualification Template into a Protocol."

Aug 09, 2022

Edit Computer Qualification Template into Protocol

Use our Computer Qualification template; follow integral completion SOP, and produce an impressive bespoke Protocol.

Continue reading "Edit Computer Qualification Template into Protocol"

Jun 14, 2022

HOW TO ENSURE YOUR REGULATORY REQUIREMENTS ARE cGMP COMPLIANT.

Regulatory requirements are easy to comply with when professionally produced protocol templates are used throughout a qualification project.

Continue reading "HOW TO ENSURE YOUR REGULATORY REQUIREMENTS ARE cGMP COMPLIANT."

Jun 13, 2022

HOW TO MAKE SPREADSHEETS CGMP OK - ADD "SPREADSHEET VALIDATE PROTOCOL

Use our popular & easy to use interactive Spreadsheet Validation document templates, Templates that are compliant with GMP regulatory expectations & Part 11. an.

Continue reading "HOW TO MAKE SPREADSHEETS CGMP OK - ADD "SPREADSHEET VALIDATE PROTOCOL"

May 07, 2022

How can I create a cGMP compliant Validation Plan protocol?

Buy our cGMP compliant template & follow the integral SOP to edit it into your own bespoke detailed plan.

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Apr 27, 2022

Validation4u | FDA | MHRA | WHO | EU | FLCV | cGMP | GxP | SOP's

Learn how validation4u; by way of tangible evidence can establish that an entity or a system conforms precisely to the cGMP rules and regulations.

Continue reading "Validation4u | FDA | MHRA | WHO | EU | FLCV | cGMP | GxP | SOP's"

Apr 03, 2022

PLC Qualification Template | Pack | VMP | VP | VRA | DQ | IQ | OQ | PQ

PLC Qualification Template, FDA,EMA & WHO compliant Protocols, Plans, SOP's, Procedural and Assessment documentation. All available for immediate download.

Continue reading "PLC Qualification Template | Pack | VMP | VP | VRA | DQ | IQ | OQ | PQ"

Oct 18, 2021

Risk Based Validation | How to avoid Life Cycle Validation Costs |

Risk Based Validation is absolutely essential for cost effective validation & defining validation is often a very critical aspect of regulatory approval..

Continue reading "Risk Based Validation | How to avoid Life Cycle Validation Costs | "

Oct 06, 2021

Validation Templates | FDA | MHRA | WHO | EU | IQ | OQ | PQ | 4Q |

Validation Online was the 1st company to supply industry standard protocol templates for cGMP use and that was over 25 years ago & 24k templates ago.

Continue reading "Validation Templates | FDA | MHRA | WHO | EU | IQ | OQ | PQ | 4Q |"

Jun 26, 2021

Validation Quality Plan | FDA | MHRA | WHO | cGMP | EU | SOP's |

Attention to detail is required in preparing a quality validation plan. Time spent in getting the detail, scope, responsibilities and boundaries properly defined and documented ensures that dreadful blunders are unlikely to appear late in the task execution.

Continue reading "Validation Quality Plan | FDA | MHRA | WHO | cGMP | EU | SOP's | "

Jun 23, 2021

Warehouse Climatic Mapping | FDA | WHO | MHRA | cGMP | EU Logging |

Learn the most cost effect and least intrusive method for complying with the Good Manufacturing Practices legislation requirement for warehouse climatic mapping. Where the accuracy of all data produced must be traceable to national standards.

Continue reading "Warehouse Climatic Mapping | FDA | WHO | MHRA | cGMP | EU Logging | "

Jun 23, 2021

Computer Vendor Audit | FDA | MHRA | WHO | EU | GAMP | SOP |

Computer Vendor Audit. FDA and GMP requirements in the USA & Associated Markets

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Jun 23, 2021

Cold Chain Validation | FDA | MHRA | WHO | EU | cGMP | SOP's | QbD |

With a failure indication of over 43%.(EC ) and 23% (US); Everything to do with; Cold Chain Validation, has overnight become the number one topic on everybody's compliance inspection list.

Continue reading "Cold Chain Validation | FDA | MHRA | WHO | EU | cGMP | SOP's | QbD |"

May 24, 2021

System Process Air | FDA | MHRA | WHO | EU | GxP | GMP's | SOP's

Never validated System Process Air before? Use an industry standard set of validation protocol templates and follow the in-built fully detailed and interactive SOP to guide you; step by step, to on-time and in-budget project completion.

Continue reading "System Process Air | FDA | MHRA | WHO | EU | GxP | GMP's | SOP's"

May 05, 2021

Laboratory Validation Package.

It is an absolute essential that your lab equipment is safely validated. and that you have continuous records that can substantiate this claim.

Continue reading "Laboratory Validation Package."

Apr 22, 2019

Online Validation

Online Validation guarantees has guaranteed for the last 15 years that purchased documents will be "will be fit for purpose".

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Apr 17, 2019

Validation Protocol Standards | FDA | EC | WHO | Pharma | Medical.....

Validation Protocol standards of wording must be accurate & unambiguous to ensure that executing a 4Q protocol produces the tangible evidence demanded

Continue reading "Validation Protocol Standards | FDA | EC | WHO | Pharma | Medical....."

Apr 17, 2019

Validation Documentation Matrix | FDA | WHO | EU | GMP | QbD | FLCV |

Validation Documentation Matrix is a reviewable indicator. It must portray the cGMP state of all mandated documents in your validation task.

Continue reading "Validation Documentation Matrix | FDA | WHO | EU | GMP | QbD | FLCV |"

Apr 17, 2019

Validation 4u | FDA | EU | WHO | GMP | QbD | FLCV | SOP's

Validation 4u methodology is the most direct route to cGMP compliance available - Use known quality interactive templates and get it right every time.

Continue reading "Validation 4u | FDA | EU | WHO | GMP | QbD | FLCV | SOP's "

Apr 16, 2019

UDI Time Schedules.

UDI Time Schedules Regulatory Expectations.

Continue reading "UDI Time Schedules."

Apr 16, 2019

Temperature Safe Transit | FDA | EU | WHO | GMP | QbD | GxP | FLCV |

The most cost method of validation of temperature safe transit systems is undoutably through using industry standard interactive validation templates. Templates which have been specifically designed to be interactive and intuative to use.

Continue reading "Temperature Safe Transit | FDA | EU | WHO | GMP | QbD | GxP | FLCV |"

Apr 16, 2019

system Hardware Validation | FDA | EU | WHO | Packages | Protocols |

System Hardware Validation docs that are ready for final edit and issue. Docs that not only guarantees compliance, but are also a first class methodology for instilling into validation staff the expectations of their regulators.

Continue reading "system Hardware Validation | FDA | EU | WHO | Packages | Protocols | "

Apr 16, 2019

SOP-GMP | FDA | EU | WHO | cGMP | QbD | FLCV | SOP's | GxP's |

The SOP-GMP legislative, as published in 21 CFR Part 210/211/820, becomes easier to understand & comply with when professionally authored, interactive & unique protocol templates such as those produced Validation Online; are used, i.e. Planned progress – with no omissions.

Continue reading "SOP-GMP | FDA | EU | WHO | cGMP | QbD | FLCV | SOP's | GxP's |"

Apr 16, 2019

Retrospective Validation | FDA | EU | WHO | GMP | FLCV | GxP | SOP's |

Retrospective Validation must be considered "a dynamic activity" - all process changes must be "reviewed for effect" on validation scope and content - This makes retrospective Validation; not only legal, but a requirement that must be applied when ever justified.

Continue reading "Retrospective Validation | FDA | EU | WHO | GMP | FLCV | GxP | SOP's |"

Apr 16, 2019

SOP for cGMP Review

SOP for cGMP Review. Uniquely Interactive and Highly Cost Effective Documents for FDA and GMP requirements in the USA & Associated Markets.

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Apr 16, 2019

Site Problem Reporting.

Site Problem Reporting.

Continue reading "Site Problem Reporting."


Combined IQ-OQ-PQ Computer (Issue-4) $159.00

This Pharmaceutical Validation combination protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’. It has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment and associated standard operating procedure TEMPLATE. The associated medical device validation  Master Plan template is interactive, easy to use and suitable for all mixes of equipment with and without software. Where temperature mapping is required it will included in this section. This of course may well be a validation A Plan template. As per 21 CFR Part 11.

The Installation Qualification Template section establishes documented verification that all medical device validation template online executables are catered for and that key aspects of the equipment Qualification adhere to approved design Qualification template and the recommendations of the manufacturer have been suitably considered. The Operational Qualification Template section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documented process validation A executables to demonstrate this. The PQ section develops documented evidence that all the requirements specified in your corporate validation 4U manual have been verified as operating consistently and exactly as specified in the medical device validation template; i.e, The User Requirement Specification template. 



User Requirements Specification (Issue 8) $115.00

This document was designed to be used as a live document up until the DQ is completed and approved. It uses three levels of URS, URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the User requirements specification template through to the final PQ and OQ functionality testing. A mandatory requirement for Full Life Cycle Validation of computer systems and compliance with Current Good Manufacturing Practice legislation. It can be used on mechanical, electrical and software controlled, monitored or driven systems and of course medical device validatioN Template along with the Software Qualification template.



Installation Qualification. SOP & Protocol (Issue 9.) $115.00 10000020

The Standard Operating Procedure template (SOP) used to generate this pharmaceutical validation IQ, takes you through the process line by line, chapter by chapter. It really is unique to find a SOP document so easy to use, all the work is done for you. All the documents are detailed, all the drawings listed and all the checks and tests detailed. The final product is a professional and comprehensive Installation Qualification Protocol. One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past, whether for medical device validatioN  TEMPLATE or for being able to produce 4 to 8, IQ protocols per 8 hour day.



Operational Qualification, SOP & Protocol (Issue 10.) $115.00 

You will find the Operational Qualification template (OQ) delightfully simple and straightforward to use, as it takes you through the process of customization of your Operational Qualification Protocol template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific 21 CFR Part 11 compliant Installation  Qualification Template. The OQ template comes complete with all the standard test scripts, more specialist test scripts can be found listed below. These can easily be pasted into the standard OQ, allowing you to quickly build your own fully detailed and referenced company bespoke Operational Qualification Protocol.