To ensure the concept of cost effective regulatory compliance was and is maintained, Validation Online used the vast field experience of its multi-disiplined team of consultants, to design and perfect a completely new suite of interactive and fully detailed validation online documents. Documentation that is written, in an easy to edit, word format, that is interactive, fully referenced and fully detailed. Documentation that was authored and targeted for the specific worldwide use of the busy technologist or manager. To enable such people to quickly raise and issue fully detailed, complaint and professional documents.

Why does something as simple as a spreadsheet figure in so many regulatory citations? Good question; and at times a difficult one to answer. When you ask a group of compliance personnel the same question you will be informed that Excel cannot be validated because it does not seal the original copy (of the spreadsheet), allows the original to be modified and has an audit trail that can be disabled. All true, but none of these problems interfere with your ability to validate that the spreadsheet is fit for purpose. They only preclude you from using the spread sheet as a compliant repository for any data that has to be store in compliance with 21 CFR Part 11.

If the spreadsheet is signed off and dated by the user, their supervisor and QA, it becomes regulatory acceptable data stored in hardcopy, and Part 11 does not apply.

After numerous requests for this, we have launched our brand new SOP for Spreadsheet Creation to cover these and other known target points that the regulators consistently hone into as soon as they find that spreadsheets are being used. Use this Spreadsheet Creation SOP to ensure that you create spreadsheets that are validatable. Then use our spreadsheet validation pack to validate them.

The SOP for Computer Equipment Validation continues to be an extremely popular document. This document leads you through the validation process, from the URS to the final P2Q.

This 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. It is interactive, easy to use and suitable for all mixes of equipment with and without software.
The IQ section establishes documented verification that key aspects of the equipment adhere to approved design intentions and that the recommendations of the manufacturer have been suitably considered. The OQ section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documentary evidence to demonstrate this. The PQ section gives documented verification that the equipment performance in its normal operating environment is consistently exactly as specified in the URS.

It now appears that the current FDA Guidance rules pertaining to 21 CFR Part 11 may be with us for a longer time than was originally anticipated. So we have incorporated the guidance suggestions in their latest guidance document, into our current Validation Risk Assessment (now issue 10), which is now available for immediate download. This VRA document now comes with a downloadable matrix for registering the justification for all your Part 11 assessments as this is now a mandatory requirement.

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Well, that is no longer a problem. Simply select the protocols you require and an electronic interactive 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 questionaire 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 or Hygrometer Calibration

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.  When calibration is done in-house, the use of saturated salt solutions as a reference is a proven and affordable method.

Validation Online Suite - VMP, cVMP, URS, VRA, DQ, IQ, OQ, PQ -

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New to validation Online or looking for company SOP?

Validation Online have just released our Standard Operating Procedure for Equipment Validation - 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.

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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 regulators 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.

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- 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.

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- USE 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.

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- FAST PRO-ACTIVE PROTOCOLS FOR YOU -

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 is such an important document. Use the 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 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.

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Design Qualification is both an emerging 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. WHILE YOUR HERE WHY NOT CLICK HERE AND LISTEN TO THE THIS UNIQUE DNA VIDEO

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- DOCUMENTATION JUST RELEASED. -

As a consultant, the most often asked for service as soon as you arrived in a clients office is, a GAP ANALYSIS. It is what everyone wants, a detailed review of all aspects of your current systems to determine compliance and adequacy of current procedures. A gap analysis involves comparing regulatory requirements against current procedures and facilities in your facility.

Every One Talks It – Very Few Have It – Get Yours Now. – Click Here.

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The Compendium of Predicate Rules (CPR) has been published to satisfy a requirement that has existed for some time now. It enables you to reference the correct cGMP identity for your requirement, when working with compliance documents. It acts as an aide-mémoire and allows you to be correct and accurate every time. No more boxing around with requirement descriptions - reference your requirements exactly. A really essential tool for all compliance professionals.

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The Computer Master Validation Plan (CVMP) along with the Computer System IQ, and the Computer System OQ, and the totally new combined IQ & OQ, for the smaller or simple piece of equipment (perfect for laboratory equipment). Three very sought after documents, in the same interactive style, complete with detailed SOP’s to lead you painlessly through the validation of computers, computer systems and or computers integral to equipment.

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- Click here for your free download of -
- VENDOR AUDIT CHECK LIST -

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- ALWAYS ON-TIME AND IN-BUDGET -

Download from Validation Online the generic Vendor Audit (VA) document in minutes, edit it following the attached SOP, incorporate your project priorities in a further 30 minutes and issue for approval signature, all in less than 60 minutes. This twenty page document allows you to weight each section of the questionnaire to exactly represent your company’s priorities. On completion the analysis allows a very detailed representation of the audited company’s GMP conformance to be confidently made.

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- UNCONDITIONALLY GUARANTEED -

These are not simple empty documents; they are detailed documents that have been successfully used by Validation Online and many others in projects for pharmaceutical and medical device manufactures and their subcontractors. Every Validation Online document is accompanied with a tailor made Standard Operating Procedure (SOP) document. This SOP details, section by section, the procedure to follow to enable you to grow your generic document, into a detailed bespoke company document.

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- WE COULD BE ON YOUR PROBLEM RIGHT NOW -

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We have an existing data base of many hundreds of protocols written for a bewildering range of equipment, facilities and utilities. From autoclaves cat 3 & 4 – freeze dryers – mixers – tabletizers – blast freezers – crogenic freezers – fillers – bottle washers – ovens – isolators – laminar flow systems – particle count – quality water – WFI – clean steam – foil presses – packing machines – refrigerators – low humidity dryers – nitrogen storage & use – oxygen storage & use- carbon dioxide storage & use – micronizers – laboratory equipment – filter integrity testers – HVAC systems – category 4 HVAC systems – clean rooms to all iso 14644 standards - and many many more protocols for production and laboratory use.

- PROJECT AHEAD OF TIME IS BRILLIANT -

A single project team member from Validation Online, has put into place 40 IQ’s in seven days, 30 OQ’s in ten days. Are you able to match these achievements?

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- UNIQUE AND URGENT REQUIREMENT -

- THEN CLICK HERE FOR FREE ADVICE -  

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If you do not see the document that you require listed in this site, please use our Validation Enquiry form, to let us know, and we will reply within 24 working hours. We are constantly adding to our lists. Our expertise includes writing many standard and specialist documents for the whole spectrum of pharmaceutical and medical device companies covering all aspects of regulatory controlled manufacturing / testing / storing / equipment, facilities and utilities. Validation Online offers a review service for any regulatory required documentation to ascertain if they comply with the applicable regulatory requirements. We have expertise in all the validation skill sets.

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We can provide your company with general compliance services. We have many years of experience in pharmaceutical manufacturing and quality assurance. We can help you comply with cGMPs, GLPs, and GCPs by developing standard operating procedures, developing validation programs and performing audits. At Validation Online we have built our reputation on providing cost effective compliant solutions to our customers when regulatory changes necessitate. Our professional staff has many years of experience in the FDA regulated industry. We can help you comply with cGMPs, QSR, GLPs, and GCPs by developing :

• Master Validation Plans
• User requirements Specification
• DQ’s, IQ’s, OQ’s and PQ’s.
• Supplementary Protocols and Summary Reports.
• Policies and Procedures
• Quality Systems
• Validation Programs
• Remediation Plans
• Training Programs
• Warning Letter Responses

In addition to the development of compliance solutions, Validation Online, can act as an independent auditing agency to provide you with that extra level of comfort that your systems are meeting the current industry standards and regulations. Whether it’s a one time audit or a recurring periodic audit you can be assured we will listen to your needs and keep the focus where it belongs: on your requirements.

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Software, Calibration, Process, Utility, Facility, Computer, Electrical, Electronic, Mechanical, Maintenance, Planning.

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