- New Protocol Package containing: VMP-VP-URS-VRA-DQ-IQ-OQ-PQ -
- for validating "503B Dispensing Pharmacy" -
Online enters its sixteenth 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, WHO and EU validation
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.
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 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.
New New New New New New New New New New
The first of the new range of document templates has now been launched. 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%. The first out are the two documents required for equipment validation (others are in pipeline). and are listed on this page (to the right of this article).
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 - 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 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 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 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.
For Your Security We are Now TLS 1.2 Compliant
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
This Validation Risk & Requirements Plan (VrrP) is one document designed specifically to replace three. The contents of the three original documents were completely revised and edited into a more compact and interactive format. Resulting in the document becoming notably easier to use and quicker to review and amend. This new format will make a very significant difference to the man hours required to produce and execute these documents. There will also be a very noticeable reduction in the time required for the reviewing and approving tasks. This new document titled the VrrP replaces the VP, VRA & URS and now compliments our equally new 4Q Protocol, which integrates the DQ/IQ/OQ/PQ into one document.
4Q Equipment Validation4u Protocol (4Q-Equip) has been designed
specifically to replace four standard protocols. By taking the
contents of the four protocol and carefully weaving them into one notably easy
to use protocol, we have made a significant advance in the task of streamlining
validation4u documentation by reducing protocol numbers by close to 75%. The
new bang up to date 4Q protocol replaces the DQ, IQ, OQ & PQ and now
compliments our equally new VrrP Protocol. By integrating the old style
DQ/IQ/OQ/PQ into one 4Q document there will be enormous savings in man hours in
the authoring, reviewing, updating and approving tasks.
For everyone's convenience, it is still written in word and compliant with FDA GMP Part 11 legislation.
This quite unique two
document package is all that is required to fully validate; to cGMP standards,
equipment used in a regulated facility. A lot of effort has gone into ensuring
that repetitive instructions and actions have been designed out and innovative
and intuitive risk-based methodologies have been incorporated.
Both documents are prefaced with a methods' Standard Operating Practice (SOP) document. These SOP’s lead you through the task of converting these highly detailed templates into your very own company bespoke protocols. The hyperlinks and cross-references within the package are; not only unique but also highly cost-effective and intuitive to use. Each document is preloaded with the test scripts (complete with acceptance criteria). All test and inspection scripts are written in MS word, to facilitate simple editing of text, layout, tables and schematics and are compliant with FDA GMP Part 11 regulations.