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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Jan 18, 2018

Equipment Qualification | FDA | EU | WHO | Pharma | Med-Dev | Bio-tec

Equipment Qualification & Validation skills are quickly adopted by staff when high quality interactive templates are used. Nothing tutors quicker or instills more permanently than actual protocols.

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Jan 15, 2018

Autoclave Validation | FDA | EU | WHO | Pharma | Med Device | Biotech |

Autoclave Validation Protocols & Packages. GMP Compliant. simply edit the fully detailed template into your own bespoke protocols.

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Jan 14, 2018

Equipment Validation | FDA | EU | WHO | Pharma | Med-Device | BioTech |

Equipment Validation & Qualification predicates the execution of specifically designed protocols to verify that the equipment is compliant with all the requirements listed in the URS.

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Jan 10, 2018

Computer equipment Validation | FDA | EU | WHO | Pharma | Med Devices | BioTech

Comprehend how using our risk based, computer equipment, validation protocol templates ensures complete FDA, WHO and EC regulatory compliance.

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Jan 07, 2018

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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Jan 07, 2018

FDA GMP PART 11 | Applicability | Compliance | Test Scripts.

Using FDA GMP PART 11 validation templates guarantee you produce the thorough and robust audit trail needed to meet all internal or external regulatory reviews or inspections.

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Jan 07, 2018

Validation Protocol Standards | FDA | EC | WHO | Pharma | Medical | Bio-tec |

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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Jan 05, 2018

Retrospective Validation | Rationale | cGMP | Justifications | Submissions |

Retrospective Validation justification legality is quite simply to establish. There are many instaces when revalidation is the best cGMP practice.n..

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Dec 20, 2017

Validation Master Plan | FDA | EU | WHO | Pharma | Med-device | Bio-tech | Test

Learn the skills of authoring a VMP that reveals to GMP compliance auditors how your company has integrated compliant practices and procedures into all relevant day to day activities.

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Dec 11, 2017

Validation | Definitive Defination | Explicitly For cGMP Regulated Industries.

Validation is the proof by way of tangible evidence that an entity or system conforms precisely to its specification.

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Dec 11, 2017

Facility Habitat | FDA | EU | WHO | Pharma | Med-Dev | Bio-tec | Dental | Mech

For all Facility Habitat tasks, learn to use Validation Online's interactive Protocols. These superbly intuitive & innovative documents will deliver the compliance that the regulators demand.

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Dec 08, 2017

Documentation Administration | FDA | EU | WHO | Pharma | Med-dev | Bio-tech

Documentation Administration that tutors and guides the student requires to be of intuitive and interactive design as all our templates are.

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Dec 07, 2017

Software Qualification | FDA | EU | WHO | Pharma | Med-Device | Bio-tech | Test

Software Qualification; Our GMP compliant docs start with a VP and progress through URS, VRA, DQ, IQ, OQ and complete with the PQ. Available as interactive package or as single documents..

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Dec 07, 2017

GAMP 5 Categories of Software | FDA | EU | WHO | Life-Cycle | FLCV |

GAMP 5 Categories, was authored by a committee; and as such, strives to answer all problems for all people. Great care is needed in identifying the sections that could be applicable in your instances.

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Dec 07, 2017

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

To understand Pharmaceutical Validation & qualification always use our intuative and interactive protocol templates - VMP through VMP, URS, DQ, IQ, OQ, to PQ.

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Dec 05, 2017

Machinery Validation - Qualification | FDA | Lathe | Mill | CNC | Press | Test

Amass the intricacies of GMP validation Qualification by using high quality templates. Nothing tutors quicker than using fully detailed, innovative, high quality, interactive templates.

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Dec 04, 2017

IQ OQ PQ Combined Protocol | FDA | EU | WHO | Pharma | Med-Device | Bio-Tech

Learn how to justify whether to use this combined IQ OQ PQ protocol or stay with the three routine individual protocols. Justification must be related to cGMP scope.

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Dec 03, 2017

Validation Templates | VMP | VP | URS | VRA | DQ | IQ | OQ | PQ | 3Q | 4Q |

Validation Template: Every document has a built in SOP for you to follow to convert these fully detailed templates into your own company bespoke document.

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Dec 01, 2017

FDA Medical Device | Templates | Qualification | Validation |Citations | Warning

Understand FDA Medical Device validation requirements by using only properly reference protocols and plans.

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Dec 01, 2017

Vendor Audit | FDA | EU | WHO | Pharma | Med-Device | Bio-tech | Test

Learning to become a Vendor Audit expert is entirely dependent on having a powerful targeted audit document. Our vendor audit document has been used by many of the major software suppliers.

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Dec 01, 2017

Temperature Mapping | FDA | EU | WHO | Pharma | Medical-Dev | Bio-Tec |

Learn the techniques and become an expert in cGMP temperature mapping requirements. Temperature Mapping documentation available for instant downnload for all studies.

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Nov 29, 2017

Biotechnology Validation

Biotechnology Validation Documentation. Interactive and detailed FDA compliant documentation for the bio-technical industries.

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Nov 28, 2017

Standard Operating Procedures

Standard Operating Procedures documents must be used for all tasks that are executed in the manufacture of cGMP regulated product.

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Nov 28, 2017

Software Validation | FDA | EU | WHO | Pharma | Med-Device | Bio-tech |Scripts

Software validation is easier to achieve using packages or Individual URS, VRA, DQ, IQ, OQ or PQ templates; interactive editing using built-in editor guarantees regulatory compliance.

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Nov 28, 2017

Performance Validation. | FDA | EU | WHO | Pharma | Med-Device | Bio-tech |

Performance Validation is executed when the equipment is validated against its design specification, as distinct from validating its use in a single process.

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Nov 28, 2017

Good Manufacturing Practice | GMP | Pharmaceutical | Medical | Biotechnical |

Good Manufacturing Practice and cGMP become standard if targeted our templates are used; documents that can guide and prompt the user along the regulative path of compliance.

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Nov 28, 2017

Computer Qualification | FDA | EU | WHO | Pharma | Med Dev | Bio-Tech | Test

Computer Qualification is easy to understand if you follow the detailed completion SOP’s that form an integral part of all of our protocol templates.

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Nov 24, 2017

Facilities Qualification | FDA | EU | WHO | cGMP | Med-Device | Bio-tec | Tests

Facilities Qualification. FDA, WHO & GMP compliant. Fast Cost Effective Protocols, SOP's, Plans & procedural documents.

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Nov 23, 2017

Corporate Quality Manual | FDA | EU | WHO | Methodologies | Plans | Procedures

Ready for you to review, edit and adopt as your own bespoke Corporate Quality Manual.

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Nov 23, 2017

Process Validation | FDA | EU | WHO | Pharma | Med-device | Bio-tech | Test

Successful process validation must certify that a system is capable of continuous critical parameter monitoring that can identify and isolate defects before the whole batch of product is contaminated.

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Nov 21, 2017

Standard Operating Procedure.

The SOP is an essential tool in the standardization and replication of production and process tasks.

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Nov 20, 2017

Operational Qualification | FDA | EU | WHO | Pharma | Med-Device | Bio-tech |

The execution an OQ must verify that all the functionality listed in the user requirements specification has been delivered in a manner compliant with FDA EU cGMP & WHO legislation.

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Nov 16, 2017

Medical Device Templates | Packages | Protocols | Plans | SOP's | Test Sipts.

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

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Nov 15, 2017

Validation Online | Drugs | Device | Bio-tec | Machine | Dental | cGMP Templates

Validation Online retails cGMP compliant Validation packages containing VMP, URS, DQ, IQ, OQ & PQ. Or the new VrrP & 4Q two document validation Package.

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Nov 13, 2017

21 211, Validation Documentation | FDA | EU | WHO | Pharma | Med-Dev | Bio-

21 211 Commonly known as 21 CFR Part 211. Easy to use fast interactive regulatory compliant document templates. Fully detailed and referenced.

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Nov 04, 2017

Planned Preventative Plant Maintenance | FDA | EU | WHO | Pharma | Med-Dev |

It is esentual that your planned preventative plant maintenance (PPPM) program is comprehensive enough to maintain your validated status.

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Oct 27, 2017

User Requirements Specification | FDA | EU | WHO | Pharma | Med-Device | Bio-

The execution of the IQ, OQ & PQ is required to produce tangible evidense that all the requirements listed in the URS have been fully satisfied.

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Oct 20, 2017

Design Qualification | FDA | EU | WHO | Pharma | Med-Device | Bio-tech | Test

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

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Oct 20, 2017

Combined IQ OQ PQ | FDA | EU | WHO | Pharma | Medi-Device | Bio-tech |

This combined IQ OQ PQ protocol was designed by us for use in simpler validation tasks. In general if an item is stand alone and of simple functionality; then this 3Q document is ideal.

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Oct 10, 2017

FAT or SAT Initiation and Execution.

FAT or SAT Superb interactive combined IQ/OQ/PQ document ready for instant download.

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Oct 02, 2017

Validation Quality Plan | Responsibilities | Methods | Deliverables | Compliance

A Detailed and Referenced Validation Quality Plan. Simply follow the interactive built in SOP to complete.

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Sep 25, 2017

Validation Risk Assessment | FDA | EU | WHO | Pharma | Med-Divice | Bio-tech |

In risk based validation - your Validation Risk Assessment (VRA) is of quintessential importance if your validation scope is going to match or exceed regulatory expectations.

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Sep 23, 2017

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

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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Sep 18, 2017

Installation Qualification | FDA | EU | WHO | Pharma | Med-Device | Bio-tech |

Installation Qualification; Our GMP compliant docs start with a VP and progresses through URS, VRA, DQ, IQ, OQ and completes with the PQ. Available as interactive package or as single documents.

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Sep 15, 2017

Performance Qualification | FDA | EU | WHO | Pharma | Med-Device | Bio-tech |

Performance Qualification (PQ) Scope. Compliant inter-active high quality Process Protocols, SOP's and many other procedural documents.

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Sep 15, 2017

Process Qualification | FDA | EU | WHO | Pharma | Med-device | Bio-tech |

Process Qualification with all process equipment validated and all procedures approved product quality must be verified using ongoing sampling techniques.

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Sep 15, 2017

GMP Calibration Requirements | FDA | EU | WHO | Pharma | Med-Device | Bio-Tech

GMP Calibration Requirements. Every FDA auditor expects to be able to review "Documented justifications for all calibration periodicities in use."

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Sep 14, 2017

Operation Validation. | FDA | EU | WHO | Pharma | Med-Device | Bio-tech |

Operational Validation. FDA and GMP requirements in the USA & Associated Markets.Documents from the URS to the PQ.

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Sep 14, 2017

Installation Validation | FDA | EU | WHO | Pharma | Med-Device | Bio-tech |

Installation Validation. Fully loaded with all pertinent test scripts. Compliant with all FDA, WHO & EU directives. Simply follow integral SOP to complete.

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