21 CFR Part 211 defines verification boundaries, mandates validation executables, documents responsibilities, maintains URS traceability & mitigates risk.
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.
Current Good Manufacturing Practices as legislated in EU and MHRA
Learn the joy of editing easy to personalize, interactive Computer System Validation templates. Proven with 20 years of continuous use & over 37K downloads.
Favored by regulators, auditors & agencies. Substantially reduces time-line & costs. Ready to edit Approve and circulate.
Learn the joy of using unique easy to personalize, interactive User Requirements templates. Very popular with consultants & line managers - over 37K downloads
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.
21 CFR Part 11 mandates practices & procedures for electronic records. Interactive & Intuitive template since 1995 with over 32k downloads.
Pharmaceutical Equipment Validation (PEV) templates that are interactive, intuitive, risk assessed & fully detailed are the preferred method.
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.
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.
Learn how validation4u; by way of tangible evidence can establish that an entity or a system conforms precisely to the cGMP rules and regulations.
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.
Computer Vendor Audit. FDA and GMP requirements in the USA & Associated Markets
Facilities HVAC validation tasks are greatly simplified when Validation Online's in-house "Facilities HVAC" designed template is used.
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.
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.
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.
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.
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.
Learn the joy of editing easy to personalize, interactive Computer Qualification Templates. Proven in 20 years of continuous use with over 37K downloads.
It is an absolute essential that your lab equipment is safely validated. and that you have continuous records that can substantiate this claim.
Validation Online Statistics are recorded and compiled by independent administrators.
How to produce Spreadsheet Validation Documents that are interactive and comply with regulatory expectations. Please review "Synopsis of regulatory displeasure".
Learn process validation techniques that automatically produce the tangible evidence that are a prerequisite for success in all process validation projects
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.
Learn the joy of editing & personalizing our interactive User Requirements Specification (URS) template. Get the URS right & the rest follows naturally
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.
The Medical Device Validation 510k must define &verify; boundaries, responsibilities, executables & requirements for medical device validation to be successful
Learn software validation techniques that automatically produce the tangible evidence that are a prerequisite for success in all software validation projects.
Regulatory requirements are easy to comply with when professionally produced protocol templates are used throughout a qualification project.
Medical Device Templates. FDA, EC, & WHO Compliant. Innovatice and Intuative documentation.
PLC Qualification, FDA, EC & WHO compliant Protocols, Plans, SOP's, Procedural and Assessment documentation. All available for immediate download.
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.
Online Validation guarantees has guaranteed for the last 15 years that purchased documents will be "will be fit for purpose".
Validation Protocol standards of wording must be accurate & unambiguous to ensure that executing a 4Q protocol produces the tangible evidence demanded
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.
Validation Documentation Matrix is a reviewable indicator. It must portray the cGMP state of all mandated documents in your validation task.
Validation 4u methodology is the most direct route to cGMP compliance available - Use known quality interactive templates and get it right every time.
UDI Time Schedules Regulatory Expectations.
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.
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.
Standard Operating Procedure (SOP's) are used to precisely replicate specific methodologies that were developed to produce a controlled product.
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.
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.
SOP for cGMP Review. Uniquely Interactive and Highly Cost Effective Documents for FDA and GMP requirements in the USA & Associated Markets.
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.
Site Problem Reporting.
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.
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;