As Validation Online enters its eighteenth consecutive year of online sales - the emphasis on cost effective validation has been demonstrated with the release of our brand new VrrP and 4Q documents. The goals remain the same - to deliver to the end user; professional intuitive and cost effective document templates. Templates that deliver compliance with all your mandated FDA, MHRA, WHO and EU validation requirements.
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.
After exhaustive reviews; ways were found to streamline our protocols and ensure repetition of descriptions or methods was avoided, while the integrity of the verification test scripts was 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 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.
Introduction to 4Q template (Contains DQ/IQ/OQ/PQ templates).
The first of the new range of document templates has now been in use for 2 years and is extremely popular. Brand new concept; same compliance but a lot less clutter and specifically designed to be innovative and intuitive. Guaranteed to reduce protocol prep time by 50%. Great convenience having all 4 protocols in one folder - great for reviewing - editing - cross referring.
Pharmaceutical Validation can be defined as the documented verification of a related group of specifications.
Which by inference means;
That if you do not have a documented specification for it; or have the capability of authoring a specification for it; - you cannot validate it.
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; from validation online, 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.
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 ..
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 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.
Validation Online released this basic Standard Operating Practice (SOP) for Equipment Validation twelve years ago - since then it has been downloaded 41.3k 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.
Protocols, such as the IQ, OQ, DQ and the PQ, along with the essential VMP, VP, URS, VRA, make up a range of regulatory required documentation that have been used on behalf of many clients and have 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 combination specific protocols.
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.
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.
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.
Validation Risk Assessment template (Issue 11) $125.00 The Risk and Part 11 Validation Risk Assessment(VRA) protocol is becoming the most important document in the validation train. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your validation risk assessment template.
This VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records. (now mandatory).
This Pharmaceutical Validation combination protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’. It has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment and associated standard operating procedure TEMPLATE. The associated medical device validation Master Plan template is interactive, easy to use and suitable for all mixes of equipment with and without software. Where temperature mapping is required it will included in this section. This of course may well be a validation risk Assessment template. As per 21 CFR Part 11.
The Installation Qualification Template or IQ section establishes documented verification that all medical device validation template online executables are catered for and that key aspects of the equipment Qualification adhere to approved design Qualification template and the recommendations of the manufacturer have been suitably considered. The Operational Qualification Template section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documented process validation A executables to demonstrate this. The PQ section develops documented evidence that all the requirements specified in your corporate validation 4U manual have been verified as operating consistently and exactly as specified in the medical device validation template; The User Requirements Specification template
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 User requirements specification template through to the final PQ and OQ functionality testing. A mandatory requirement for Full Life Cycle Validation of computer systems and compliance with Current Good Manufacturing Practice legislation. It can be used on mechanical, electrical and software controlled, monitored or driven systems and of course medical device validatioN Template along with the Software Qualification template.
The Standard Operating Procedure template (SOP) used to generate this installation Qualification template (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 template. 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, whether for current Good Manufacturing Practice use medical device use or a simple installation qualification template.
You will find the Operational Qualification template (OQ) 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 21 CFR Part 11 compliant Installation Qualification Template. 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, along with the installation qualification template.
This combination document gives you basically 2 for 1 value. The Factory Acceptance Testing (FAT) and the Site Acceptance Testing (SAT) are very closely related. In the 'FAT' instance (which should be executed in the suppliers establishment), all aspects of design will be verified for compliance with the cGMP functionality specified in the URS. Completion and approval of the FAT, should allow shipment to point of use to be made. The SAT, must replicate the FAT plus all the additional test and inspections that are required to verify that all the 'installation specifications' as documented in the URS, have been fully satisfied. It is essential that the FAT is used to verify that all aspects of the performance Qualification template specified in the URS are working as specified, before the equipment is verified as ready for commissioning and then validation.