VALIDATION ONLINE DOCUMENTATION CENTRE.



Introduction to Validation Online Services.

As Validation Online enters it's fifteenth consecutive year of online sales - its goals remain the same - to deliver to the end user; professional intuitive document templates, that will in the most cost effective manner, deliver compliance with your mandated FDA, WHO and or EU validation requirements.
Over the past decade and a half our team of highly experienced consultants have worked with most of the major Bio-technical, medical and pharmaceutical companies in the world. Their time has been spent not only in satisfying the necessary international and local regulatory requirements, but in also ensuring that the most cost effective methods of doing so; were and are, used.

To ensure the concept of cost effective regulatory compliance was and is maintained, Validation Online used not only the academic qualities of their various specialists; but also their collective accumulation of hands-on field experience, to design and perfect a completely new package of interactive and fully detailed validation online documents. Documentation that is written in an easy to edit; interactive word format. A format that is very obviously targeted for the specific worldwide use of the busy technologist or manager based in an FDA, WHO or EC regulated pharmaceutical, medical device or bio-technical facility. Thus enabling these people to quickly raise and issue fully detailed, compliant and professional documents.


Your Use Of Our Documents.

Since legislation, science and engineering in all of their formats are for ever changing; validation requirements have to change, and all mandated validation documentation must be capable of synchronizing with, and or, capturing these changing requirements. Simply put this means that we write documents that are appropriate for the current requirements; as we have found them. In all probability, these requirements will change and the documents will no longer be Fit-For-Purpose. If it is decided that the documents must be made currently Fit-For-Purpose - they will be reviewed, revised and reissued with a new approved issue level and date.


The purchasing of a registered document entitles you to use the document as often as you require. After recurrent use, we would expect you to check that it is still the current standard. Shortly we will be incorporating into our site a reference system that will greatly expedite this task for you; currently, people email us.


The document you purchased today could still be current in weeks, months or years. However, it could be re-written within a few weeks if the requirement arises. Out of date documents cannot be updated – a current issue level document must be purchased.


Protocols wanted in a hurry and in the most cost effective manner possible?

Well, that is no longer a problem. Simply select the protocols you require and an electronic interactive validation questionnaire will be instantly emailed to you. Complete the questionnaire and then click on the 'Submit Button'. One of our validation online specialists will then, use the information on the completed questionnaire and an appropriate in-house template to produce a fully detailed, bespoke, ready to use, validation protocol for your use.


The Importance of Humidity Sensor calibration.

Humidity sensors require frequent calibration and continual monitoring, they are, the most prone to error sensors in general facility use. Where as most sensors measure to within (plus or minus) 1% and have have extremely low drift rates. Most humidity sensors measure to within (plus or minus) 3% at mid range and 5-7% at the top and bottom of their ranges, and have a significant drift rate. In a standard Heating, Ventilating and Air Conditioning (HVAC) system, a humidity sensor that over reads the incoming air humidity will drive the cooling coils to maximum chill, as it tries to remove the moisture it is erroneously sensing. This severely chilled air then requires maximum heating from the heat coils to attain and maintain room temperatures. This vicious energy burning situation often goes completely unnoticed and can increase energy consumption by as much as 400% per AHU. This is the very reason that humidity sensor accuracy is one of the most important energy conservation concerns. Read further .. 

Humidity Calibration Kit descriptions.   Humidity Calibration Kit Purchase .

 

From:  VAISALA news

No humidity instrument stays accurate on its own. From time to time, the performance of these instruments must be checked against a reference standard.  When calibration is done in-house, the use of saturated salt solutions is unquestionably the most proven, affordable and expeditious method to use.


Validation Document Packages.

Validation project or equipment to execute? Then use our most popular document package. When you use our Package of inter-related and interactive documents the qualification task is properly scoped referenced and detailed. No loose ends. It becomes a smooth flowing efficient task, with progress and completion times being accurately predicted and achieved. Traceability of testing is maintained from the URS, to the PQ, a cGMP requirement. Validation Online Packages are available for most tasks.Click below, then select the section applicable to your requirement and view the packages available.



New to validation Online or looking for company SOP?

Validation Online released this basic Standard Operating Practice (SOP) for Equipment Validation twelve years ago - since then it has been downloaded 23.7k times. It has also been reproduced (with our permission) 37 times and incorporated into college syllabus's 16 times. This SOP takes you through the validation process for equipment, from the very early first stages, to the final closing stage. It will ensure that your validation is seamless, and that the correct documents are raised, approved, executed, reviewed and accepted correctly. It shows how to use validation tools such as the very important matrix control document and equally important risk assessments, along with the integration of the three level URS.


Validation Document Requirements

Protocols, such as the IQ, OQ, DQ and the PQ, along with the essential VMP, VP, URS, VRA and often an FMEA, make up a range of regulatory required documentation that has been used on behalf of many clients and has been repeatedly subjected to Regulatory Authority scrutiny. These, Part 11 compliant documents are continually under GMP review by Validation-Online to ensure that they conform to the FDA, WHO & EU regulator's current requirements and expectations. These standard format validation protocols are complemented with the addition of detailed specific protocols such as Computer System Validation (CSV)- VMP - IQ - OQ -IQ/OQ, HVAC IQ - OQ - PQ, and Facilities IQ - QO - PQ.



Reduce Your Validation Costs.

Why use up your budget authoring new VMP’s, URS, VP, VRA and GxP documentation for each and every validation project you are involved in, when there is quality documentation, at budget prices,available in minutes from Validation Online. Documentation that you can instantly down-load, and convert in minutes, from a generic, to a company bespoke document, using the attached detailed SOP. The SOP is an impressive tool to use, taking you quickly (section by section)through the document completion process. You can show a massive saving in the normal project validation budget, by using these documents. Result is, you look good and so does the project time line.


Proven Quality Documents.

Download, the Validation Online, generic Installation Qualification Protocol (IQ) or Operational Qualification Protocol (OQ) directly from Validation Online, auto populate it in minutes, run through the attached SOP and transform the document into your own bespoke company document in 20 minutes, complete remaining requirements in 30 minutes, and issue for approval signatures, all in less than 60 minutes. Repeat this process for many other regulatory required documents and protocols.



Fast Pro-active Protocols.

A recent survey highlighted that 32% of all equipment procurement is unsatisfactory simply because the companies concerned did not accurately request what they actually needed.


This is why the User Requirements Specification (URS) is such an important document. Use this right-up-to date URS from Validation Online (User Requirements Specification), the only URS available that uses a three level approach to ensure that the traceability demanded for life-cycle validation, is maintained. Auto populate it, and follow the SOP to complete it, then you have the required regulatory traceability from your User Requirements Specification (URS) to the Design Specification (DS) that the FDA, WHO & EU regulators now demand. This document ensures that a fully referenced and traceable DQ can be developed and executed, it also simplifies validation, especially software validation.


Design Qualification (DQ) is both a regulatory requirement and a tool for project success. If structured and executed properly, it can help assure the design is robust and complete, giving the project team and QA reviewers a high degree of confidence that every requirement has been factored into the design. Finally, DQ cannot be performed without first formally defining requirements. Meeting requirements is the ultimate objective of the project; verifying requirements have been met is the role of qualification.



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Validation Master Plan (Issue 7) -- $115.00

This document follows our proven practice of supplying a interactive generic document with an automatic method of populating it. Once populated, all you need to do is follow the prompts in the attached SOP. They will take you through the completion process section, by section. At the end of this process your generic document has progressed into a detailed, referenced, bespoke company document. The document follows our three level URS system that ensures functionality traceability from the URS to the various testing protocols. This document interfaces with our Validation Risk Assessment (VRA), Validation Project Plan (VP), User Requirements Specification (URS), giving a seamless flow from your VMP through the VP - IQ - OQ - PQ, while integrating flawlessly with the URS - DQ - VRA.

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Validation Plan (Issue 8) -- $89.00

This document follows our well-developed method of using a generic document and allowing the customer to apply an attached detailed SOP to it, turning the generic document quickly into a first class company bespoke document. This VP details and integrates all validation activities and procedures required for a small to medium sized project, involving production/facility/utility equipment using electronic controls or monitoring.

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User Requirements Specification (Issue 7.) -- $115.00

The document that sets the standard, and specifies your requirements in a manner that ensures when a system or piece of equipment is selected, it will deliver the functions you want, it will have maintenance standards, it will have calibration records, it will have all the documents and records to enable successful validation to be completed. This document was designed to be used as a live document up until the DQ is completed and approved. It uses three levels of URS, URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the URS through to the final PQ and OQ functionality testing.  This is a mandatory requirement for Full Life Cycle Validation (FLCV) of computer systems that are the subject of predicate rules. It can be used on mechanical, electrical and software controlled, monitored or managed systems.

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Design Qualification (Issue 4.) -- $115.00

The Standard Operating Procedure attached to this generic design qualification protocol, will chapter by chapter, take you through the task of raising a fully detailed document. The main body is split into fourteen tables, each one probing the design requirements and standards for the individual requirement. Safety and security along with user operability are very detailed. The document will lead you through all these design aspects allowing you to delete some you feel are not important to your equipment. It is an easy document to use and will ensure that you’re DQ’s are relevant, up to date and easy to execute. Practically all the requirements are in table form. Allowing fast and clearly presented results to be obtained.

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Installation Qualification. SOP & Protocol (Issue 9.) -- $115.00

The SOP used to generate this IQ, takes you through the process line by line, chapter by chapter. It really is unique to find a SOP document so easy to use, all the work is done for you. All the documents are detailed, all the drawings listed and all the checks and tests detailed. The final product is a professional and comprehensive Installation Qualification Protocol: One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past. There is now no reason for not being able to produce 4 to 8, IQ protocols per 8 hour day.


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Operational Qualification, SOP & Protocol (Issue 10.) --$115.00

You will find the step by step attached SOP delightfully simple and straightforward to use, as it takes you through the process of customization of your Operational Qualification Protocol template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific Operational Qualification Protocol. The OQ template comes complete with all the standard test scripts, more specialist test scripts can be found listed below. These can easily be pasted into the standard OQ, allowing you to quickly build your own fully detailed and referenced company bespoke Operational Qualification Protocol. Template for VMP.

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