For all Building HVAC validation tasks, learn to use Validation Online's interactive & intuitive Protocols. Superbly easy to use documentation.
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.
21 CFR Part 211 Must define: boundaries, responsibilities & executables. Must specify: test scripts, traceability & risk.
Pharmaceutical Equipment Validation (PEV) templates that are interactive, intuitive, risk assessed & fully detailed are the preferred method.
2019 – 483’s up. Keep your current Good Manufacturing Practice compliant by using templated protocols & packages which are interactive and intuative in use.
Validation Temperature Mapping requirements are simplified when an industry standard protocol template with a guidance SOP to steer you all the way is used.
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.
Process Validation – Weighs Methods | Process Validation – Verifies Accuracy | Process Validation - Creates Records | Process Validation – Verifies Efficacy |
Standard Operating Procedure (SOP's) are used to precisely replicate specific methodologies that were developed to produce a controlled product.
Validation Documentation Matrix is a reviewable indicator. It must portray the cGMP state of all mandated documents in your validation task.
GAMP 5 - Weighs Methods | GAMP 5 - Classifies Risk | GAMP 5 - Itemizes Tasks | GAMP 5 - Defines Scope | GAMP 5 - Details Tasks | GAMP 5 - Lists Executables |
Equipment qualification using professionally prepared templated documents helps to ensure that fewer blunders appear later-on in the task execution stage.
URS-level 1 = End user needs: URS-Level 2 = Executables + Training + Facility needs. URS-Level 3 = Software functionality in Level 1.
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.
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.
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.
Execution of a Design Qualification (DQ) protocol must produce tangible verification that all requirements listed in the URS are fully satisfied.
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.”
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.
The 510k must define boundaries, responsibilities, executables & requirements along with defining life cycle, traceability, risk, maintenance & calibration.
Validation 4u methodology is the most direct route to cGMP compliance available - Use known quality interactive templates and get it right every time.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
Validation Online retails cGMP compliant Validation packages containing VMP, URS, DQ, IQ, OQ & PQ. Or the new VrrP & 4Q two document validation Package.
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.
Learn how validation4u; by way of tangible evidence can establish that an entity or a system conforms precisely to the cGMP rules and regulations.
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.