Validation Online Compliant Templates.
Any auditor: Regulatory or Routine has the right to review your Risk Based Practice and history.
This makes the "Validation Risk Assessment" a Super Critical Document.
May 25, 2022
HOW TO EDIT AN OPERATIONAL QUALIFICATION TEMPLATE INTO A PROTOCOL.
If you use our cGMP Operational Qualification compliant template & you follow the integral SOP you will edit it into a bespoke detailed & impressive Protocol.
Continue reading "HOW TO EDIT AN OPERATIONAL QUALIFICATION TEMPLATE INTO A PROTOCOL."
May 16, 2022
HOW TO STICK TO CURRENT GOOD MANUFACTURING PRACTICES (cGMP).
Use our own cGMP compliant templates to ensure that all your procedures and processes are in conformance with 21 CFR Part 210/211/820/11
Continue reading "HOW TO STICK TO CURRENT GOOD MANUFACTURING PRACTICES (cGMP)."
May 08, 2022
How can I create cGMP compliant IQ OQ PQ protocols
Use our cGMP compliant template & follow the integral SOP to edit it into your own bespoke detailed & impressive Protocol.
Continue reading "How can I create cGMP compliant IQ OQ PQ protocols"
May 08, 2022
How can I create cGMP compliant computer system validation protocols?
Use our cGMP compliant templates & follow the inbuilt SOP, which will edit them into your own bespoke, detailed & impressive Protocol.
Continue reading "How can I create cGMP compliant computer system validation protocols?"
May 07, 2022
How can I create a cGMP compliant Validation Plan protocol?
Buy our cGMP compliant template & follow the integral SOP to edit it into your own bespoke detailed plan.
Continue reading "How can I create a cGMP compliant Validation Plan protocol?"
May 07, 2022
How can I create a cGMP compliant IQ OQ PQ protocol/?
Use our cGMP compliant template & follow the integral SOP to edit it into your own bespoke detailed & impressive Protocol.
Continue reading "How can I create a cGMP compliant IQ OQ PQ protocol/?"
May 07, 2022
How can I create cGMP compliant protocols for Autoclave qualification
By using validation interactive detailed templates ready to edit into your own bespoke company FDA compliant protocol.
Continue reading "How can I create cGMP compliant protocols for Autoclave qualification"
May 07, 2022
Validation Online Stats | Packages | Protocols | Plans | SOP's | Test
Validation Online Statistics are recorded and compiled by independent administrators.
Continue reading "Validation Online Stats | Packages | Protocols | Plans | SOP's | Test "
May 01, 2022
21 CFR Part 11 * Protects and secures digital records and signatures *
The intent of 21 CFR Part 11 is to ensure that predicated retention records are held in a format that renders unauthorized editing or deletion impossible.
Continue reading "21 CFR Part 11 * Protects and secures digital records and signatures *"
Apr 27, 2022
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.
Continue reading "Validation4u | FDA | MHRA | WHO | EU | FLCV | cGMP | GxP | SOP's"
Apr 22, 2022
How can I produce a professional User Requirements Specification?
Procure our Interactive cGMP compliant, fully detailed template; then follow the integral Completion SOP & proudly sign off your own bespoke URS.
Continue reading "How can I produce a professional User Requirements Specification?"
Apr 21, 2022
How can I produce a CGMP compliant Validation Master Plan protocol ?
Purchase our Interactive cGMP compliant, fully detailed template; then follow the integral completion SOP & proudly sign off, your own bespoke protocol.
Continue reading "How can I produce a CGMP compliant Validation Master Plan protocol ?"
Apr 08, 2022
Computer Qualification Template| FDA | EU | WHO | MHRA | cGMP | CSV |
Learn the joy of editing easy to personalize, interactive Computer Qualification Template Proven in 20 years of continuous use with over 37K downloads.
Continue reading "Computer Qualification Template| FDA | EU | WHO | MHRA | cGMP | CSV |"
Apr 06, 2022
Process Qualification template | FDA | MHRA | EU | WHO | cGMP | GMP |
Process Qualification template used to require three trial batches to be produce and the quality verified. That is still required with certain products.
Continue reading "Process Qualification template | FDA | MHRA | EU | WHO | cGMP | GMP |"
Apr 03, 2022
PLC Qualification Template | Pack | VMP | VP | VRA | DQ | IQ | OQ | PQ
PLC Qualification Template, FDA,EMA & WHO compliant Protocols, Plans, SOP's, Procedural and Assessment documentation. All available for immediate download.
Continue reading "PLC Qualification Template | Pack | VMP | VP | VRA | DQ | IQ | OQ | PQ"
Apr 01, 2022
Performance Qualification template | FDA | MHRA | WHO | EMA |
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.
Continue reading "Performance Qualification template | FDA | MHRA | WHO | EMA | "
Mar 26, 2022
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.
Continue reading "21 CFR Part 211 | FDA | MHRA | EU | WHO | GMP | "
Mar 25, 2022
Design Qualification | FDA | MHRA | EMA | WHO | Validation Online |
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.
Continue reading "Design Qualification | FDA | MHRA | EMA | WHO | Validation Online |"
Jan 03, 2022
Pharmaceutical Equipment Validation Compliant 21 CFR Part 210/211/820
Suitable most equipment with or without software facility. Simply follow Interactive completion SOP & edit into a 21 CFR Part 210/211/820 compliant protocol.
Continue reading "Pharmaceutical Equipment Validation Compliant 21 CFR Part 210/211/820"
Dec 13, 2021
Spreadsheet + Critical data = Mandatory Validation Requirement.
Use our popular & easy to use interactive Spreadsheet Validation document templates, Templates that are compliant with GMP regulatory expectations & Part 11. an.
Continue reading "Spreadsheet + Critical data = Mandatory Validation Requirement."
Oct 18, 2021
Risk Based Validation | How to avoid Life Cycle Validation Costs |
Risk Based Validation is absolutely essential for cost effective validation & defining validation is often a very critical aspect of regulatory approval..
Continue reading "Risk Based Validation | How to avoid Life Cycle Validation Costs | "
Oct 06, 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.
Continue reading "Validation Templates | FDA | MHRA | WHO | EU | IQ | OQ | PQ | 4Q |"
Sep 11, 2021
Software Qualification | FDA | MHRA | WHO | EU | 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 | MHRA | WHO | EU | QbD | FLCV | SOP's |"
Aug 08, 2021
Software Validation | FDA | MHRA | WHO | EU | 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.
Continue reading "Software Validation | FDA | MHRA | WHO | EU | FLCV | SOP | GAMP-5 |"
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.
Continue reading "Validation Quality Plan | FDA | MHRA | WHO | cGMP | EU | SOP's | "
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.
Continue reading "Warehouse Climatic Mapping | FDA | WHO | MHRA | cGMP | EU Logging | "
Jun 23, 2021
Computer Vendor Audit | FDA | MHRA | WHO | EU | GAMP | SOP |
Computer Vendor Audit. FDA and GMP requirements in the USA & Associated Markets
Continue reading "Computer Vendor Audit | FDA | MHRA | WHO | EU | GAMP | SOP |"
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.
Continue reading "Facilities HVAC | FDA | MHRA | WHO | cGMP | FLCV | EU | SOP | GAMP-5 |"
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.
Continue reading "Cold Chain Validation | FDA | MHRA | WHO | EU | cGMP | SOP's | QbD |"
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.
Continue reading "System Process Air | FDA | MHRA | WHO | EU | GxP | GMP's | SOP's"
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 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
Continue reading "Process Validation | FDA | MHRA | EU | WHO | GMP | FLCV | GAMP-5 |"
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.
Continue reading "Validation executables | FDA | EU | WHO | cGMP | FVLC | SOP's | QbD |"
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
Continue reading "Medical Device Validation | FDA | EU | WHO | cGMP | GAMP-5 | Med Div |"
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.
Continue reading "Regulatory Requirements | FDA | EU | WHO | cGMP | FVLC | QbD | SOP | "
May 13, 2019
Medical Device Templates | FDA | EC | WHO | cGMP | QbD | GXP | GDP |
Medical Device Templates. FDA, EC, & WHO Compliant. Innovatice and Intuative documentation.
Continue reading "Medical Device Templates | FDA | EC | WHO | cGMP | QbD | GXP | GDP |"
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
Continue reading "Validation Protocol Standards | FDA | EC | WHO | Pharma | Medical....."
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.
Continue reading "Validation Documentation Matrix | FDA | WHO | EU | GMP | QbD | FLCV |"
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.
Continue reading "Validation 4u | FDA | EU | WHO | GMP | QbD | FLCV | SOP's "
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.
Continue reading "Temperature Safe Transit | FDA | EU | WHO | GMP | QbD | GxP | FLCV |"
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.
Continue reading "system Hardware Validation | FDA | EU | WHO | Packages | Protocols | "
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.
Continue reading "Standard Operating Procedure | FDA | EU | WHO | GMP | QbD | GxP | QxP"
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.
Continue reading "SOP-GMP | FDA | EU | WHO | cGMP | QbD | FLCV | SOP's | GxP's |"
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.
Continue reading "Retrospective Validation | FDA | EU | WHO | GMP | FLCV | GxP | SOP's |"
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
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.
Continue reading "Pharmaceutical Validation | FDA | EU | WHO | Pharma | Med-Device | Bio"