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 22, 2018

Temperature Mapping | FDA | EU | WHO | cGMP's | FLCV | GxP | SOP's |

Learn the techniques and become an expert in cGMP compliant temperature mapping requirements. Temperature Mapping documentation available for instant download for fixed and mobile installation qualification studies.

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Sep 22, 2018

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

Learn the legal complexities involved in authoring Operational Qualification protocols, by using first class professionally produced templates. Fully referenced & risk rated, with built in traceability, all ready for you to edit them into your own bespoke protocol.

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Sep 22, 2018

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

New validation templates were designed specifically to ensure that the basic attributes demanded by the regulators; applicable to each document type, were always there.

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Sep 22, 2018

GMP Calibration Requirements | FDA | EU | WHO | cGMP | QbD | SOP's |

GMP Calibration Requirements mandate that calibration periodicities for all critical sensors; used in any regulated process, must be established using a documented company approved methodology. The records generated are to be considered reviewable predicated data.

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Sep 19, 2018

Validation Master Plan | FDA | EU | WHO | cGMP | QbD | FLCV | SOP's |

Learn the easy way; use an industry standard, Validation Master Plan (VMP) template & follow the integral completion SOP. This will prompt you into documenting, individual responsibilities, boundaries, methodologies & legislative requirements as specified in cGMP's.

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Sep 19, 2018

GAMP 5 Categories | FDA | EU | WHO | QbD | GMP | FLCV | SOP | SOP's |

Although "Good Automatic Manufacturing Practices Issue 5" - GAMP 5 - is not a legal requirement, it does contain some interesting and useful methodology. It is therefore; up to the end user, to extract and apply the methodology that is appropriate to their requirements.

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Sep 15, 2018

Facilities Qualification | FDA | EU | WHO | cGMP | QbD | FLCV | SOP |

Facilities Qualification or validation demands a great deal of attention to detail. Time spent in getting the scope, responsibilities, boundaries and methodologies properly defined will ensure that your validation task progresses in accordance with the planed time-line.

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Sep 14, 2018

Standard Operating Procedures | FDA | EU | WHO | cGMP | QbD | GxP |

Learn why Standard Operating Procedures (SOP's) documents are mandatory throughout all cGMP controlled industries. Tasks that are executed in the manufacture of cGMP regulated product must be concisely documented to guarantee continuous repetitive replication of the process.

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Sep 14, 2018

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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Sep 13, 2018

Facility HVAC | FDA | EU | WHO | cGMP | FLCV | QbD | QxP | SOP's |

For all Facility HVAC 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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Sep 13, 2018

FAT or SAT | FDA | EU | WHO | cGMP's | FLCV | QbD | QxD | SOP's |

FAT or SAT defined: The FAT or Factory Acceptance Testing is written & executed at the vendors test facility & usually witnessed by the client. It involves exhaustive testing of all aspects of the system. The SAT or Site Acceptance Testing is executed at the clients site.

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Sep 12, 2018

Process Validation | FDA | EU | WHO | cGMP | FLCV | QbD | SOP | GxP |

Learn how to successfully ensure that your automated process validation verifies that all product parameters that can influence any of the products predicated requirements are continuously monitored. Any out-of-specification - must immediately stop the process.

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Sep 12, 2018

current Good Manufacturing Practice | FDA | EC | WHO | GMP | QbD | GXP

Learning & understanding the FDA’s requirements for protocols and standard operating procedure documentation; as published in, “Current Good Manufacturing Practice (GMP)” is greatly simplified for the end user, when fully detailed, interactive, templates are made available.

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Sep 12, 2018

21 CFR Part 11 | FDA | EU | WHO | cGMP's | FLCV | QbD | SOP's | GxP |

Study and learn how the requirements detailed in 21 CFR Part 11 can render electronic signatures and data as secure as the manually produced and cumbersome; to archive data, it was designed to replace.

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Sep 11, 2018

Corporate Validation Manual | FDA | EU | WHO | SOP's | QbD | SOP's |

Learn the clever way; use an industry standard, Corporate Validation Manual (CVM) template & follow the in-built fully detailed & interactive SOP, in setting out the scopes, responsibilities, boundaries, methodologies & legislative requirements as per 21 CFR Part 210.

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Sep 10, 2018

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

Equipment qualification or validation demands a great deal of attention to detail. Time spent in getting the scope, responsibilities and boundaries properly defined and documented ensures that dreadful blunders are unlikely to appear later-on in the task execution stage.

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

Sep 10, 2018

Compressed Air Validation | FDA | EU | WHO | cGMP | FLCV | QbD | SOP |

Where compressed plant air is used in production processes, any contact with regulatory controlled product or associated containers necessitates that the air in use is certified to be of an appropriate standard.

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Sep 10, 2018

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

It must be understood that validation is a dynamic activity - it is subjected to changes - therefore we must be ready to incorporate these changes. This makes retrospective Validation; not only legal, but a requirement that must be applied when ever justified.

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Sep 09, 2018

Temperature Controlled Transport | FDA | EU | WHO | GMP | QbD | GxP |

Study & learn about validation of temperature controlled transport by executing the integral SOP (built into each of our templates) will lead you through the process of evolving the template into a company bespoke cGMP protocol. The easier way of mastering cGMP.

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Sep 09, 2018

21 211 | FDA | EU | WHO | cGMP | FLCV | GxP | QbD | SOP's |

21 211. Must define: boundaries, responsibilities, deliverables & requirements. Must specify: life cycle, test scripts, traceability & risk. Must scope: protocols, maintenance & calibration. Must produce: tangible evidence of all validation activities.

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Sep 07, 2018

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

Learn the easy way; use industry standard, cGMP compliant Combined IQ-OQ-PQ templates. Fully detailed, intuitive and interactive. Available for: General Equipment: Computer Equipment: Spreadsheets: Quality Steam: Software: Without a doubt the most popular download.

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Sep 06, 2018

Computer equipment Validation | FDA | EU | WHO | cGMP | FLCV | SOP |

Learn all about computer equipment validation by using our fully detailed intuayive and interactive templated document. Follow the inbuilt SOP and edit this template into your own Good Manufacturing Practice (GMP) compliant bespoke company protocol.

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Sep 06, 2018

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

Study and learn 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.

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Sep 06, 2018

Installation Qualification | FDA | EU | WHO | cGMP | QbD | FLCV | SOP

Learning is much easier when professional standard templated Installation Qualification protocols are used. With all details and methodologies in place, the end user is only required to edit the already detailed interactive protocol to suit their exact requirements.

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Sep 05, 2018

GMP Vendor Audit | FDA | EU | WHO | GMP | FLCV | QbD | GxP's | SOP's |

Learning to conduct an impartial GMP vendor audit is entirely dependent on having a properly weighed & targeted audit document, which will allow percentage compliance to be indicated. Auditors will often review it, and suppliers may even contest its legality and objectivity.

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Sep 05, 2018

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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Sep 05, 2018

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

Learn the ideosyncracies of authoring an "User Requirements Specification" (URS) document. The execution of the IQ, OQ and PQ protocols must produce tangible evidence verifying that every requirement listed in the URS has been fully satisfied.

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Sep 05, 2018

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

Training and learning are greatly enhanced when high quality interactive professionally authored Performance Qualification (PQ) templated protocols are in use. Intensity and frequency of all testing, scoping and inspection tasks are all reviewed and sensibly managed.

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Sep 05, 2018

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

Learn to use our Quality by Design (QbD) interactive IQ OQ PQ combination templated protocol to assure your validation task is correctly risk assessed, scoped appropriately & FDA predicated traceability from User Requirements to Test Scripts is verifiably maintained.

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Sep 05, 2018

Corporate Quality Manual | FDA | EU | WHO | cGMP | FLCV | QbD | SOP |

Learn how to turn this comprehensive in-depth Corporate Quality Manual template, into your own company's bespoke manual; detailing exactly how your company has integrated "continued Good Manufacturing Practices" requirements into all regulated daily activities.

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Sep 02, 2018

Validation | FDA | EU | WHO | QbD | FLCV | cGMP | GxP | SOP's

Learn how validation; 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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Sep 01, 2018

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.

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Aug 28, 2018

Software Validation | FDA | EU | WHO | cGMP | QbD | FLCV | PLC

Learn how software validation becomes intuitive when third generation 4Q protocols and plans are used. Start with the Validation, Requirements, Risk & Plan (VrrP) and finish with the combined Design Installation Operation & Performance Protocol (4Q). Simpler & Swifter.

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Jul 24, 2018

510k | FDA | EU | WHO | cGMP | QbD | SOP's | Med Div | Pharma |

510k. Must define: boundaries, responsibilities, deliverables & requirements. Must specify: life cycle, test scripts, traceability & risk. Must scope: protocols, maintenance & calibration. Must produce: tangible evidence of all validation activities.

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Jul 23, 2018

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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Jun 21, 2018

Design Qualification | FDA | EU | WHO | cGMP | QbD | Pharma | BioTech

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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May 20, 2018

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.

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May 19, 2018

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

Tutoring staff in validation skills is made easier when interactive fully detailed templated protocols are used. The possibility of discovering seriously embarrassing omissions when halfway through the execution stage is very costly & can be deleterious to one’s health.

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May 12, 2018

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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May 10, 2018

Validation Risk Assessment | FDA | EU | WHO | Pharma | Med-Device | Bi

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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May 10, 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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May 10, 2018

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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May 09, 2018

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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May 09, 2018

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 09, 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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May 08, 2018

Biomed Design Validation (DV).

Biomed Design Validation (DV). GMP compliant, uniquely interactive and highly cost effective Protocols, Plans, SOP's, Risk assessment and many other procedural documents.

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May 06, 2018

Performance Validation. | FDA | EU | WHO | Drugs | QbD | 4Q Protocol |

Performance Validation is when the equipment is validated throughout the full range of its designed capabilities. Usually contract manufacturers validate full equipment specification, whereas actual drug manufacturers will only validate what is used in their own processes.

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May 06, 2018

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

Pharmaceutical Equipment Validation made easy, simply follow intuative protocols and learn by using innovative templates authored by seasoned professionals.

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May 05, 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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