Validation Online Compliant Templates.
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Jul 22, 2021
21 CFR Part 211 | FDA | MHRA | EU | WHO | GMP |
21 CFR Part 211 defines verification boundaries, mandates validation executables, documents responsibilities, maintains URS traceability & mitigates risk.
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Jul 22, 2021
Autoclave Validation | FDA | MHRA | WHO | EU | GMP | 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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Jul 20, 2021
Current Good Manufacturing Practices | FDA | MHRA | EU | WHO | cGMP |
Current Good Manufacturing Practices as legislated in EU and MHRA
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Jul 20, 2021
Computer System Validation | FDA | MHRA | WHO | EU | DCS | PC | PLC |
Learn the joy of editing easy to personalize, interactive Computer System Validation templates. Proven with 20 years of continuous use & over 37K downloads.
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Jul 20, 2021
Combined IQ OQ PQ | FDA | MHRA | WHO | cGMP | FLCV | SOP's| GxP |
Favored by regulators, auditors & agencies. Substantially reduces time-line & costs. Ready to edit Approve and circulate.
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Jul 19, 2021
User Requirements | FDA | MHRA | EU | WHO | cGMP | SOP |
Learn the joy of using unique easy to personalize, interactive User Requirements templates. Very popular with consultants & line managers - over 37K downloads
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Jul 08, 2021
Performance Qualification | FDA | MHRA | WHO | cGMP | EU | GxP
This stand alone PQ template is also available as an integral part of the superb interactive, intuitive & SOP prompted 4Q (dq/iq/oq/pq) combination protocol.
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Jul 01, 2021
21 CFR Part 11 | FDA | MHRA | WHO | EU | FLCV | SOP's | GAMP-5 |
21 CFR Part 11 mandates practices & procedures for electronic records. Interactive & Intuitive template since 1995 with over 32k downloads.
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Jun 29, 2021
Pharmaceutical Equipment Validation | FDA | MHRA | WHO | EU | cGMP |
Pharmaceutical Equipment Validation (PEV) templates that are interactive, intuitive, risk assessed & fully detailed are the preferred method.
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Jun 26, 2021
Validation Quality Plan | FDA | MHRA | WHO | cGMP | EU | 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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Jun 23, 2021
Operational Qualification | FDA | MHRA | WHO | GMP | EU | SOP | GxP |
This stand alone OQ template is also available as an integral part of the superb interactive, intuitive & SOP prompted 4Q (dq/iq/oq/pq) combination protocol.
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Jun 23, 2021
Validation4u | FDA | MHRA | WHO | EU | 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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Jun 23, 2021
Warehouse Climatic Mapping | FDA | WHO | MHRA | cGMP | EU 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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Jun 23, 2021
Computer Vendor Audit | FDA | MHRA | WHO | EU | GAMP | SOP |
Computer Vendor Audit. FDA and GMP requirements in the USA & Associated Markets
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Jun 23, 2021
Facilities HVAC | FDA | MHRA | WHO | cGMP | FLCV | EU | 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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Jun 23, 2021
Design Qualification | FDA | MHRA | WHO | cGMP | EU | FLCV | SOP |
This stand alone DQ template is also available as an integral part of the superb interactive, intuitive & SOP prompted 4Q (dq/iq/oq/pq) combination protocol.
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Jun 23, 2021
Cold Chain Validation | FDA | MHRA | WHO | EU | 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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Jun 22, 2021
Validation Templates | FDA | MHRA | WHO | EU | IQ | OQ | PQ | 4Q |
Validation Online was the 1st company to supply industry standard protocol templates for cGMP use and that was over 25 years ago & 24k templates ago.
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Jun 16, 2021
Validation Master Plan | FDA | MHRA | WHO | EC | cGMP |
Learn how easy it is to produce a fully bespoke company plan from our Validation Master Plan template. Over 37k downloads in last 20 years.
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May 24, 2021
System Process Air | FDA | MHRA | WHO | EU | 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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May 11, 2021
Computer Qualification | FDA | EU | WHO | MHRA | cGMP | CSV |
Learn the joy of editing easy to personalize, interactive Computer Qualification Templates. Proven in 20 years of continuous use with over 37K downloads.
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May 05, 2021
Laboratory Validation Package.
It is an absolute essential that your lab equipment is safely validated. and that you have continuous records that can substantiate this claim.
Apr 29, 2021
Validation Online Stats | Packages | Protocols | Plans | SOP's | Test
Validation Online Statistics are recorded and compiled by independent administrators.
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Apr 26, 2021
Spreadsheet Validation | FDA | MHRA | EU | WHO | Pharma | Bio-Tech |
How to produce Spreadsheet Validation Documents that are interactive and comply with regulatory expectations. Please review "Synopsis of regulatory displeasure".
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Apr 13, 2021
Process Validation | FDA | MHRA | EU | WHO | GMP | FLCV | GAMP-5 |
Learn process validation techniques that automatically produce the tangible evidence that are a prerequisite for success in all process validation projects
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Mar 13, 2021
IQ-OQ-PQ | FDA | MHRA | EC | WHO | cGMP | SOP | GAMP 5 |
Learn how this modern interactive IQ-OQ-PQ template can be simply edited into your own personalized bespoke protocol. Over 18.2K downloads in last 12 years.
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Feb 06, 2021
Equipment Qualification | FDA | EU | WHO | MHRA | cGMP |
Learn the joy of editing & personalizing our interactive User Requirements Specification (URS) template. Get the URS right & the rest follows naturally
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Oct 29, 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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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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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.
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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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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 22, 2019
Online Validation
Online Validation guarantees has guaranteed for the last 15 years that purchased documents will be "will be fit for purpose".
Apr 17, 2019
Validation Protocol Standards | FDA | EC | WHO | Pharma | Medical.....
Validation Protocol standards of wording must be accurate & unambiguous to ensure that executing a 4Q protocol produces the tangible evidence demanded
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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 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
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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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
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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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.
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
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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Vendor Audit Package $199.00
When goods or services are purchase by a cGMP approved organization from a none cGMP approved vendor; it is a legal requirement that the would-be purchaser audits the supplier to establish the scope of any work required to render the item or process cGMP compliant
This elevates the Vendor Audit (VA) Document to a “Must be in Place” status. So, your list of pre validation doc's must include: (VA) + (FAT) + (SAT)
These are mandatory & available as a package;