Validation Online Compliant Templates.

Validation Online retails a range of fully detailed and referenced FDA, EC and WHO compliant document templates that were specifically designed to be used in complying with all of the current Good Manufacturing Practice (cGMP) requirements. The template range extends from the VMP to the VP and through the URS, VRA, DQ, IQ to the PQ. The range of templates also includes all the attendant validation support documentation and SOPs. To produce your own bespoke document, simply start by acquiring the appropriate state of the art template from our range and executing the in-built interactive SOP that forms a preface to the document. Execution of this preface will quickly produce your own bespoke document.
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Sep 17, 2019

Validation Templates | VMP | VP | URS | VRA | DQ | IQ | OQ | PQ | 4Q |

Validation Templates were first designed for GMP use by this company, when we found that our “On Site” consultants were all authoring the same documents; but producing their own unique versions. Now; 14 years later, the latest edition of each document is instantly available

Continue reading "Validation Templates | VMP | VP | URS | VRA | DQ | IQ | OQ | PQ | 4Q |"

Aug 05, 2019

Validation4u | FDA | EU | WHO | QbD | 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.

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Aug 01, 2019

IQ-OQ-PQ | FDA | EU | WHO | cGMP's | SOP's | GxP's | FLCV | GAMP 5 |

Our combined IQ-OQ-PQ template makes a brilliant aid-memoir for the expert or a fabulous tutor for the student. Thoughtfully designed; hence easy to use.

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Jul 31, 2019

Validation Master Plan | FDA | EU | WHO | GMP | GAMP-5 | FLCV | SOP |

Follow the integrated SOP & convert this interactive Validation Master Plan template, into your own bespoke FDA compliant intuitive Validation Master Plan.

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Jul 28, 2019

Process Validation | FDA | EU | WHO | GMP | FLCV | QbD | SOP | GAMP-5

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

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Jul 25, 2019

Facilities HVAC | FDA | EU | WHO | cGMP | FLCV | QxP | SOP | GAMP-5 |

Facilities HVAC validation tasks are greatly simplified when Validation Online's in-house "Facilities HVAC" designed template is used.

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Jul 17, 2019

current Good Manufacturing Practice | FDA | EU | WHO | GMP | GAMP-5 |

Keep your current Good Manufacturing Practice compliant by using professionally designed intuitive templates. Interactive templates available for all docs.

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Jul 16, 2019

Medical Device Validation | FDA | EU | WHO | cGMP | GAMP-5 | Med Div |

The Medical Device Validation 510k must define &verify; boundaries, responsibilities, executables & requirements for medical device validation to be successful

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Jul 11, 2019

21 CFR Part 211 | FDA | EU | WHO | cGMP | FLCV | QbD | SOP | GAMP-5 |

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

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Jul 09, 2019

21 CFR Part 11 | FDA | EU | WHO | cGMP's | FLCV | SOP's | GAMP-5 |

21 CFR Part 11 compliant software must be used in all instances where data mandated by 21 CFR Part 11 is to be stored or held in an editable format.

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Jun 28, 2019

Software Validation | FDA | EU | WHO | cGMP | FLCV | SOP | GAMP-5 |

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

Continue reading "Software Validation | FDA | EU | WHO | cGMP | FLCV | SOP | GAMP-5 |"

Jun 24, 2019

Computer Validation | FDA | EU | WHO | GMP | FLCV | SOP | VbD | GAMP-5

Learn computer validation techniques that automatically produce the tangible evidence that are a prerequisite for successful of computer validation projects.

Continue reading "Computer Validation | FDA | EU | WHO | GMP | FLCV | SOP | VbD | GAMP-5"

Jun 21, 2019

Combined IQ OQ PQ | FDA | EU | WHO | cGMP | QbD | FLCV | SOP's| GxP |

Learn how to edit combined IQ-OQ-PQ templates by using use our industry standard, cGMP compliant, fully detailed, combined IQ-OQ-PQ template.

Continue reading "Combined IQ OQ PQ | FDA | EU | WHO | cGMP | QbD | FLCV | SOP's| GxP |"

Jun 03, 2019

Equipment Qualification | FDA | EU | WHO | cGMP | FLCV | DbQ | SOP's |

Equipment Qualification can be defined as; The planned verification of a group of facts; by way of tangible evidence.

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May 21, 2019

Operational Qualification | FDA | EU | WHO | GMP | FLCV | SOP | GxP |

The FDA has mandated that the execution of the Operational Qualification (OQ) must produce reviewable evidence which verifies that all Operational-needs, as listed in the User Requirements; are found to equal or surpass their documented acceptance criterias.

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May 20, 2019

Regulatory Requirements | FDA | EU | WHO | cGMP | FVLC | QbD | SOP |

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

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May 13, 2019

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

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

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May 12, 2019

PLC Qualification | Packages | Protocols | Plans | SOP's | Test.....

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

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May 12, 2019

Design Qualification | FDA | EU | WHO | cGMP | QbD | FLCV | SOP | GxP

Execution of a Design Qualification (DQ) protocol must produce tangible verification that all requirements listed in the URS are fully satisfied.

Continue reading "Design Qualification | FDA | EU | WHO | cGMP | QbD | FLCV | SOP | GxP "

Apr 25, 2019

Risk Based Validation | FDA | EU | WHO | Pharma | Med-Devise | Bio-t..

For compliance with regulatory requirements a methodology must be used that ensures the intensity of validation; is proportional to the complexity & critically of the item under qualification.

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Apr 24, 2019

Computer Qualification | FDA | EU | WHO | cGMP | FLCV | QbD | SOP's |

Study and learn the idiosyncrasies of computer qualification by following the integral SOP's that form part of each of our protocol templates. Following these SOP's will take you through the process of changing these templates into your own company bespoke cGMP protocols.

Continue reading "Computer Qualification | FDA | EU | WHO | cGMP | FLCV | QbD | SOP's |"

Apr 23, 2019

Validation Quality Plan | FDA | EU | WHO | cGMP | QbD | 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.

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Apr 22, 2019

Online Validation

Online Validation guarantees that your protocols will be fit for purpose. Just follow the prefaced interactive SOP to produce cGMP compliant documents.

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Apr 20, 2019

Cold Chain Validation | FDA | EU | WHO | FLCV | 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.

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Apr 17, 2019

Autoclave Validation | FDA | EU | WHO | GMP | QbD | SOP | GxP | FLCV |

All our Autoclave Validation Protocols templates contain integral SOP’s. These SOP's contain step by step instructions for editing the template into a protocol.

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Apr 17, 2019

Warehouse Climatic Mapping | FDA | WHO | EU | cGMP | Data 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.

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Apr 17, 2019

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

Validation Protocol standards of wording used in protocols must be accurate & unambiguous to ensure that executing a protocol produces the tangible evidence required to prove regulatory compliance.

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Apr 17, 2019

Validation Plan | FDA | EU | WHO | cGMP | QbD | GxP | FLCV |

Learn that the Validation Plan demands meticulous attention to detail to ensure that a properly balanced schedule of activities is developed. Basic rules and methodologies must be used to determine whether the depth of validation activies is appropriate.

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Apr 17, 2019

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

Validation Online Stats; Record this as one of the most commen audit statements - “Your investigations into deviations and out-of-specification (OOS) laboratory results are insufficient, and do not include scientifically-supported conclusions.”

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Apr 17, 2019

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

Validation Executables The integrity of individual protocols is kept to ensure compliance. The 4Q combined DQ/IQ/OQ/PQ is now much easier to work and control.

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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.

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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.

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Apr 16, 2019

User Requirements Specification | FDA | EU | WHO | cGMP | QbD | SOP |

URS-level 1 = End user needs: URS-Level 2 = Executables + Training + Facility needs. URS-Level 3 = Software functionality in Level 1.

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Apr 16, 2019

UDI Time Schedules.

UDI Time Schedules Regulatory Expectations.

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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 Process Air | FDA | EC | WHO | QbD | FLCV | 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 | EC | WHO | QbD | FLCV | GxP | GMP's | SOP's"

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.

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Apr 16, 2019

Standard Operating Procedure | FDA | EU | WHO | GMP | QbD | GxP | QxP

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

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Apr 16, 2019

Spreadsheet Validation | FDA | EU | WHO | Pharma | Med-Dev | Bio-Tech.

How to produce Spreadsheet Validation Documents that are intuitive, interactive and fully detailed.

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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.

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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

Software Qualification | FDA | EU | WHO | cGMP | QbD | FLCV | SOP's |

Learn how the use of a Software Qualification document package can ensure that your validation task is properly structured, adequately risk assessed and not over scoped. GMP compliant docs start with a VP and progress through URS, VRA, DQ, IQ, OQ and completes with the PQ.

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Apr 16, 2019

Site Problem Reporting.

Site Problem Reporting.

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Apr 16, 2019

Process Qualification | FDA | EU | WHO | cGMP | QbD | FLCV | SOP's |

Process Qualification used to require three trial batches to be produce and the quality verified. That is still required with certain products. For bulk produce the requirement is for is continuous monitoring of critical parameters & rapid intervention of any OOS's.

Continue reading "Process Qualification | FDA | EU | WHO | cGMP | QbD | FLCV | SOP's |"

Apr 16, 2019

Pharmaceutical Validation | FDA | EU | WHO | Pharma | Med-Device | Bio

Learn the idiosyncrasies of Pharmaceutical Validation by using Validation Online’s uniquely intuitive cGMP compliant templates. An integrated SOP in each document will guide you through the process of converting the template into your own company bespoke document.

Continue reading "Pharmaceutical Validation | FDA | EU | WHO | Pharma | Med-Device | Bio"

Apr 16, 2019

Pharmaceutical Equipment Validation | FDA | EU | WHO | GMP | QbD | SOP

Pharmaceutical Equipment Validation (PEV) templates that are interactive, intuitive, risk assessed & fully detailed are the preferred method.

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Apr 16, 2019

Performance Qualification | FDA | EC | WHO | cGMP | QbD | GxP | FLCV |

Training & learning are greatly enhanced when high quality interactive professionally authored Performance Qualification (PQ) templated protocols are used.

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Apr 16, 2019

part-11-update

part-11-update

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