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Jan 21, 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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Jan 21, 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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Jan 20, 2019
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.
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Jan 20, 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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Jan 20, 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 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 20, 2019
Process Validation | FDA | EU | WHO | cGMP | FLCV | QbD | SOP | GxP |
Validation must verify that all critical parameters are continuously monitored and that the process will be halted if any of these parameters go out-of-specification (OOS). OOS product must be segregated from within specification (WS) product.
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Jan 20, 2019
Temperature Mapping | FDA | EU | WHO | cGMP | FLCV | GxP | SOP | QbD |
Understanding validation temperature mapping requirements is simplified when industry standard protocol templates with an integral guidance SOP takes you through the completion process step by step. cGMP compliance and on-time completion are guaranteed.
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Jan 19, 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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Jan 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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Jan 17, 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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Jan 17, 2019
Standard Operating Procedures | FDA | EU | WHO | GMP | QbD | GxP | QxP
Each Standard Operating Procedure (SOP) details step by step, execution of a regulatory controlled procedure. The regulatory authorities consider both this methodology & execution of the procedures to be “critical records of cGMP compliant production” I.E. predicated data.
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Jan 17, 2019
GAMP 5 | FDA | EU | WHO | QbD | cGMP | FLCV | SOP's | SOP's | GxP |
Although GAMP 5 - Good Automatic Manufacturing Practices Issue 5 - is legally unenforceable, it does debate some practical and useful methodologies. However, the end user is left to select the methodologies most appropriate to their regulatory obligations and requirements.
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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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Jan 16, 2019
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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Jan 15, 2019
IQ-OQ-PQ | FDA | EU | WHO | cGMP's | SOP's | GxP's |
Learn the techniques required to be regarded an expert in authoring IQ-OQ-PQ validation protocols that are interactive & intuitive not only in their editing but also in their ability during execution to produce the tangible evidence of compliance required by the regulators
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Jan 14, 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
Continue reading "Validation Templates | VMP | VP | URS | VRA | DQ | IQ | OQ | PQ | 4Q |"
Jan 13, 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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Jan 11, 2019
current Good Manufacturing Practice | FDA | EC | WHO | GMP | QbD | GXP
The FDA’s “current Good Manufacturing Practices (cGMP)” legislative, as published in 21 CFR Part 210/211/820, becomes easier to understand & comply with when our professionally designed interactive & unique protocol templates are used. Planned progress – with no omissions.
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Jan 11, 2019
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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Jan 09, 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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Jan 07, 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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Jan 07, 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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Jan 07, 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. These superb easy to use documents will lead you step by step through the validation process.
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Jan 07, 2019
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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Dec 12, 2018
Temp Safe Transit | FDA | EU | WHO | GMP | QbD | GxP | FLCV | GxP |
Study & learn that the most cost effective way of validating Temp Safe Transit transport systems is by using industry standard interactive validation templates. Templates which have been cpecifically designed to lead you through the validation process step, by step.
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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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Dec 02, 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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Nov 21, 2018
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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Nov 18, 2018
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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Nov 17, 2018
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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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.
Continue reading "SOP-GMP | FDA | EU | WHO | cGMP | QbD | FLCV | SOP's | GxP's |"
Nov 17, 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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Oct 31, 2018
Validate a Process | FDA | EU | WHO | GMP | QbD | FLCV | SOP's | GxP |
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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Oct 29, 2018
Pharmaceutical Equipment Validation | FDA | EU | WHO | GMP | QbD | SOP
Validation Online design pharmaceutical equipment validation templates that are interactive, intuitive, risk assessed & detailed. The end-user is required to follow the integral SOP which will lead him/her through the completion process & produce an FDA compliant protocol.
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Oct 04, 2018
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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Sep 26, 2018
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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Sep 23, 2018
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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Sep 23, 2018
HVAC Qualification | FDA | EU | WHO | cGMP | FLCV | QbD | SOP | GxP |
Tutoring staff in HVAC qualification skills is made easier when interactive fully detailed templated validation protocols are used. The possibility of discovering seriously embarrassing omissions late in the execution stage is costly & can be deleterious to one’s health.
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Sep 23, 2018
System Process Air | FDA | EC | WHO | QbD | FLCV | GxP | GMP's | SOP's
Never validated 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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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 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
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 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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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.
Continue reading "Operation Validation. | FDA | EU | WHO | Pharma | Med-Device | Bio"
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.
Continue reading "Validation Quality Plan | FDA | EU | WHO | cGMP | QbD | SOP's | "
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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