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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Jul 10, 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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Jul 09, 2018

21 CFR Part 11 | Drugs | Medical Devices | Bio Tech | FDA | cGMP | SOP

21 CFR Part 11 Compliance Application & Verification is built into all our IO's and OQ's. The test Scrips are also available separately.

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Jun 25, 2018

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

Learn the idiosyncrasies of the regulatory requirements contained in "Current Good Manufacturing Practices” legislation, by actual “hands on” editing and execution of industry standard fully detailed, innovative, high quality SOP’s, plans and protocols.

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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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Jun 20, 2018

GAMP 5 Categories Software | FDA | EU | WHO | QbD | cGMP | FLCV | LC |

GAMP 5 is an acronym for "Good Automatic Manufacturing Practices Issue 5". Compiled by a committee as a guidance document it strives to answer all problems for all people. The end user must sift through it and extract that which is appropriate to your activities.

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Jun 20, 2018

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

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

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Jun 13, 2018

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

Successful process validation must certify that an automated systems is capable of continuously monitoring; for compliance, all product parameters affected by the said process and that all predicated data is recorded & stored stored iaw companies published procedures.

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Jun 01, 2018

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

Validation Templates: Each cGMP mandated document has a built in SOP for you to follow through the intricacies of converting these fully detailed templates into your own company bespoke regulatory compliance documents.

Continue reading "Validation Templates | VMP | VP | URS | VRA | DQ | IQ | OQ | PQ | 3Q |"

Jun 01, 2018

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

Learn why Standard Operating Procedures (SOP's) documents are mandated 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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May 25, 2018

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

Learning to conduct an impartial vendor audit is entirely dependent on having a properly weighed and 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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May 21, 2018

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

VMP is an acronym for "Validation Master Plan", which must verify; by way of documented evidence, that all relevant requirements detailed in 21 CFR Part 210/820 have been integrated into all cGMP related activities undertaken by the company, or on behalf of the company.

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May 20, 2018

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

Study and learn by following the integral SOP that forms part of each of our documents. Following these SOP's will take you through the process of changing these templates into your own company bespoke cGMP documents - VMP through VP, URS, VRA, DQ, IQ, OQ, & PQ.

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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 19, 2018

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

Learn how software validation can be greatly expedited 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 & Peformance Protocol (4Q). Simpler & Swifter.

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May 15, 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.

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

May 14, 2018

IQ OQ PQ | FDA | EU | WHO | GMP | QbD | Pharma | Med Div | Bio Tech |

Learn how the use of our Quality by Design (QbD) interactive IQ OQ PQ combination protocol templates can assure your validation task is correctly risk assessed, scoped appropriately & traceabilities between User Requirements & Test Scripts are portrayed in a matrix display.

Continue reading "IQ OQ PQ | FDA | EU | WHO | GMP | QbD | Pharma | Med Div | Bio Tech | "

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

zzz-21 211, Validation Documentation | FDA | EU | WHO | Pharma |

zzz-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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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

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

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

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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

Retrospective Validation | Rationale | cGMP | Plans | Protocols |

Retrospective Validation is legal and allowed. Far better that you find and remove any cGMP inadequacies rather than having a visiting auditor publish them.

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May 09, 2018

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

OQ is an acronym for Operational Qualification. Execution of an OQ must produce tangible evidence certifying that all aspects of the equipment under qualification operate within the specifications listed within the User Requirements Specification.

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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

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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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 09, 2018

FAT or SAT Initiation and Execution.

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

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May 08, 2018

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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May 08, 2018

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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May 08, 2018

Combined IQ OQ PQ | FDA | EU | WHO | Pharma | Med-Device | 3Q Protocol

This 3Q protocol contains IQ, OQ & PQ protocols that have been integrated & edited to ensure that all wasteful repetition of tests or inspections in the execution stage; have been removed. With a little care; planning, can now integrate many activities with commissioning.

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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

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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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

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

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

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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 06, 2018

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

Equipment Qualification & Validation skills are acquired & adopted by staff, when they are using high quality interactive templates. Nothing tutors more quickly or instills more permanently than actual using quality interactive templated protocols.

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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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May 01, 2018

zzz-data Logger.

zzz-Data Logger Specification.

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Apr 28, 2018

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

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 28, 2018

User Requirements Specification | FDA | EU | WHO | cGMP | Pharma | Tes

URS is an acronym for "User Requirements Specification". Which is the most important document in the validation process. The execution of the IQ, OQ and PQ protocols must produce tangible evidence that every requirement listed in the URS has been fully satisfied.

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Apr 27, 2018

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

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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Apr 24, 2018

Validate a Process | FDA | EU | WHO | GMP | Pharma | Med Div | BioTech

Need to validate a process in the most expedient and efficient way possible; then use Validation Online's high quality fully referenced protocol templates. Templates that will "pass muster" with your compliance regulators and be economical with your validation budget.

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Mar 17, 2018

System Process Air | FDA | EC | WHO | Protocol | Plan | Package | GMP

Learn all about System Process Air validation. Since air is used in numerous processes throughout any production facility, it must be subjected to the rigors of validation to ensure that it is fit for purpose.

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Feb 27, 2018

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

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

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Feb 21, 2018

VALIDATION GAP ANALYSIS | FDA | EU | WHO | Pharma | Med Dev | Bio-tec

Validation Gap Analysis enables you to audit your client's cGMP status. Ensures that the required VMP to PQ via VMP. URS, DQ, IQ, and OQ protocols are cGMP compliant.

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Jan 29, 2018

Regulatory Requirements | 21 CFR | Parts 820 - 211- 210 & 11

Compliance with Regulatory requirements requires the use of fully detailed templates. Innovative by design and intuative when used ensures your validation will be comprehensive and robust.

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