Validation Online Compliant Templates.
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Mar 25, 2019
Building HVAC | FDA | EU | WHO | cGMP | FLCV | QbD | QxP | SOP's
For all Building HVAC validation tasks, learn to use Validation Online's interactive & intuitive Protocols. Superbly easy to use documentation.
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Mar 24, 2019
IQ-OQ-PQ | FDA | EU | WHO | cGMP's | SOP's | GxP's | FLCV |
Our combined IQ-OQ-PQ is interactive, intuitive and makes a brilliant aid-memoir for the expert or fabulous tutor for the student. Fully detailed & referenced.
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Mar 24, 2019
21 CFR Part 211 | FDA | EU | WHO | cGMP | FLCV | GxP | QbD | SOP's |
21 CFR Part 211 Must define: boundaries, responsibilities & executables. Must specify: test scripts, traceability & risk.
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Mar 21, 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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Mar 20, 2019
current Good Manufacturing Practice | FDA | EC | WHO | GMP | QbD | GXP
2019 – 483’s up. Keep your current Good Manufacturing Practice compliant by using templated protocols & packages which are interactive and intuative in use.
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Mar 19, 2019
Temperature Mapping | FDA | EU | WHO | cGMP | FLCV | GxP | SOP | QbD |
Validation Temperature Mapping requirements are simplified when an industry standard protocol template with a guidance SOP to steer you all the way is used.
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Mar 17, 2019
Software Validation | FDA | EU | WHO | cGMP | QbD | FLCV | SOP | GxP |
Learn how software validation becomes intuitive when industry standard templates are used. Simply; allow the integral interactive SOP to guide you step by step through the completion process and on to in-budget and on-time line completion.
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Mar 17, 2019
Process Validation | FDA | EU | WHO | cGMP | FLCV | QbD | SOP | GxP
Process Validation – Weighs Methods | Process Validation – Verifies Accuracy | Process Validation - Creates Records | Process Validation – Verifies Efficacy |
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Mar 17, 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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Mar 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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Mar 13, 2019
GAMP 5 | FDA | EU | WHO | QbD | cGMP | FLCV | SOP's | SOP's | GxP |
GAMP 5 - Weighs Methods | GAMP 5 - Classifies Risk | GAMP 5 - Itemizes Tasks | GAMP 5 - Defines Scope | GAMP 5 - Details Tasks | GAMP 5 - Lists Executables |
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Mar 11, 2019
Equipment Qualification | FDA | EU | WHO | cGMP | FLCV | DbQ | SOP's |
Equipment qualification using professionally prepared templated documents helps to ensure that fewer blunders appear later-on in the task execution stage.
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Mar 11, 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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Mar 08, 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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Mar 05, 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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Mar 05, 2019
Validation Master Plan | FDA | EU | WHO | cGMP | QbD | FLCV | SOP's |
Master the Validation Master Plan (VMP) - follow the integral SOP - This will steer you through the process of editing the template into your VMP document.
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Mar 05, 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.
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Mar 04, 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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Mar 04, 2019
Validation Risk Assessment | FDA | EU | WHO | QbD | FLCV | GMP | SOP |
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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Mar 02, 2019
510k | FDA | EU | WHO | cGMP | QbD | SOP's | Med Div | Pharma |
The 510k must define boundaries, responsibilities, executables & requirements along with defining life cycle, traceability, risk, maintenance & calibration.
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Feb 23, 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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Feb 18, 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.
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Feb 18, 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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Feb 18, 2019
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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Feb 18, 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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Feb 18, 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.
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Feb 16, 2019
Computer equipment Validation | FDA | EU | WHO | cGMP | FLCV | SOP |
Learn all about computer equipment validation by using fully detailed intuitive and interactive templates and simply following the inbuilt completion SOP to edit this template into your own Good Manufacturing Practice (GMP) compliant bespoke company protocol.
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Feb 15, 2019
Corporate Quality Manual | FDA | EU | WHO | cGMP | FLCV | QbD | SOP |
Included with this Corporate Quality Manual template, all ready to edit & use, twenty popular protocols templates, six popular SOP templates & eighteen test/inspection scripts. Just follow the integrated completion SOP to produce your own company bespoke Quality Manual.
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Feb 15, 2019
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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Feb 15, 2019
21 CFR Part 11 | FDA | EU | WHO | cGMP's | FLCV | QbD | SOP's | GxP |
The 21 CFR Part 11 software must be used within a frame work of documented mandatory procedures for the stored data to be considered “secure”. The physical safety & security of this software and associated documented procedures along with all hardware must validated.
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Feb 11, 2019
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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Feb 11, 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.
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Feb 06, 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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Feb 06, 2019
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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Feb 06, 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.
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Feb 05, 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
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Feb 04, 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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Feb 04, 2019
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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Feb 04, 2019
GMP Calibration Requirements | FDA | EU | WHO | cGMP | QbD | SOP's |
GMP Calibration Requirements mandate that calibration periodicities for all critical sensors; used in regulated process, must be established using documented company approved methodology. The records generated are to be considered reviewable predicated data.
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Feb 04, 2019
Performance Validation. | FDA | EU | WHO | QbD | GMP | FLCV | SOP's |
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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Feb 03, 2019
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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Feb 03, 2019
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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Feb 01, 2019
Autoclave Validation | FDA | EU | WHO | GMP | QbD | SOP | GxP | FLCV |
All our Autoclave Validation Protocols templates contain integral SOP’s. These templates contain step by step instructions for editing the template into a company bespoke protocol. All calculations and methodologies are fully into described and illustrated where needed.
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Jan 23, 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.
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Jan 20, 2019
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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Jan 16, 2019
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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Jan 16, 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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Dec 11, 2018
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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Nov 17, 2018
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.
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