Understand how to write a superb validation online protocol. Even as we enter our eighteenth consecutive year of online sales - the emphasis is still on producing cost effective documentation that is targeted at main stream pharmaceutical companies. The goals remain the same - to deliver to the end user; professional intuitive and cost effective document templates. Templates that ensure 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 to develop the, how to write a superb validation online protocols; concept, 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 understand how to write superb validation documents that are acceptable as fully detailed, compliant and professional documents.
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 Online 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 online 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 validation online popular document packages. 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 online 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 Online 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 such as; How to write a superb validation online protocol 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.
This validation online 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.