Any auditor: Regulatory or Routine has the right to review your Risk Based Practice and history.
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21 CFR Part 211 defines verification boundaries, mandates validation executables, documents responsibilities, maintains URS traceability & mitigates risk.
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How to compile and execute a 21-CFR-Part-11 Test protocol which will ensure all mandated retention records are held in secure controlled access system.
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How to produce superb User Requirement Specifications is explained in the interactive lead-through SOP integral to this template.
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Understand Current Good Manufacturing Practice legislation and ensure your; protocols and plans are compliant with it.
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How to create a winning Standard Operating Procedure precisely replicate specific methodologies that were developed to produce a controlled product.
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How to write Retrospective Validation Protocols that will accurately certify current system compliance with URS..
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How to produce a superb combined IQ OQ PQ Protocol that is intuitive to edit & use. Comply's with 21 CFR Part 820/210/211/11 Follow integral lead-thro SOP to complete.
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Validation Online Statistics are recorded and compiled by independent administrators.
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Compliant Interactive Templates for Computer System Validation Simply follow integral SOP to fully bespoke into your own company Protocol.
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Understanding how to write a superb Design Qualification protocol is fully explained in the integral SOP built in to each template
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Understanding how to write a superb Computer Qualification Protocol is fully explained in the integral SOP built in to each of our templates.
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Understanding how to write a superb Warehouse Climatic Control protocol is fully explained in the integral SOP built in to each of our templates.
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How to write superb Medical Device Qualification protocols is detailed and defined in the integral SOP contained in all our templates.
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Understanding how to write a superb Autoclave Validation protocol is fully explained in the integral SOP built in to to each of our templates.
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Understanding how to write a superb Validation Plan is fully explained in the integral SOP built in to each of our templates.
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It is an absolute essential that your lab equipment is safely validated. and that you have continuous records that can substantiate this claim.
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PLC Qualification Template, FDA,EMA & WHO compliant Protocols, Plans, SOP's, Procedural and Assessment documentation. All available for immediate download.
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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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SOP for cGMP Review. Uniquely Interactive and Highly Cost Effective Documents for FDA and GMP requirements in the USA & Associated Markets.
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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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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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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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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Validation A is our Interactive cGMP compliant, fully detailed template; then follow the integral completion SOP & proudly sign off, your own bespoke protocol.
Edit this Validation Performance Qualification Template, using the integral SOP to produce your own impressive company bespoke Protocol.
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Regulatory requirements are easy to comply with when professionally produced protocol templates are used throughout a qualification project.
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Facilities HVAC validation tasks are greatly simplified when professional templates are used, Simply follow integral SOP and produce your own bespoke protocol.
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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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Validation is the verification of a related group of specifications.
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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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Risk Based Validation is absolutely essential for cost effective validation & defining validation is often a very critical aspect of regulatory approval..
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Understanding how to write a superb process validation template is fully explained in the SOP built in to each of our templates.
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Understanding how to write a superb Cold Chain Validation protocol is fully explained in the integral SOP built in to each of our templates.
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Understanding how to write a superb Spreadsheet Validator protocol is fully explained in the integral SOP built in to each of our templates
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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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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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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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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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Computer Vendor Audit. FDA and GMP requirements in the USA & Associated Markets
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Understanding how to write a superb Software Qualification protocol is fully explained in the interactive integral SOP built in to each of our templates.
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Understanding how to write a superb Operational Qualification protocol is fully explained in the integral SOP built in to each template.
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Understanding how to write a superb Equipment Qualification protocol is fully explained in the integral SOP built in to to each template.
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Process Qualification template used to run batches and check quality. Today the emphasis is on continuous product monitoring. tain products.
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