Contact Details DOC SHOP
Introduction.
Validation Enquiry
Site Statistics
Site Problems
Phone; 703-9035
Free Newsletter
Contact Us Directly.
Protocols & Plans: Agency Reviewed
Autoclave Validate
Computer Validation
Biotech Validation
Climatic Cabinets
Computer Qualify
Comb'd IQ-OQ-PQ
Utility Air Valid'n
Com. Vender Audit
Design Qualification
Design Validation
Facility Qualification
HVAC Qualification
Comb'd IQ-OQ
IQ/OQ/PQ Proto'ls
Installation Qualify
Installation Validation
LAN Validation
Operation Qualify
Operat'l Validation
Performance Qualify
Performance Validat
Pharma Validation
Process Qualification
Process Validation
Spreadsheet Validat
Software Qualify
Software Validation
Steam Quality
Temp. Mapping
User Requirements
Validation Plans.
Val. Master Plans
Validation Packages
Procedural Docs: FMEA
CAPA Audit
Gap Analysis Tool
cGMP Validation
Predicate Rules
Risk Assessment
SOP for SOP
SOP for cGMP Rev
SOP Validation
Validation Matrix
Vender Audit.
Hard Ware/Copy BSI Standards
Contracted Validate
Data Loggers
Quality Manual
Humidity Calibration
Validation Manual
Tele Conference
Technical Info: CSV Annex 11
Free Vendor Audit
GAMP 5
Glossary
GMP Problems.
Hardware Validation
Measuring Instr's.
Med Devise Validate
21 CFR Part 11
Part 11 Update
21 CFR Part 211
21 CFR PART 820
Pharma Maint'ance
Procedures
Protocol Standards
Validation Protocols.
Validation Blog
Video News
Retro-Validation
Warning Letters
Your Free Glossary
General Info: Calculators For All
Conditions of Use
Corpus Clock
Customer List
Product for License
Regulat'y Authorit's
Computer Val Process
Useful Links.
Free Downloads
Advertising With us.
21 CFR Part 11.
Validation Academy
Templates
Warehouse Mapp'g

Validation Online for FDA and GMP requirements in the USA & Associated Markets.
XML RSS
Add to Google
Add to My Yahoo!
Add to My MSN
Subscribe with Bloglines

VALIDATION ONLINE DOCUMENTATION CENTRE.

Introduction to Validation Online Services.


Validation Online offers you professional assistance and advice to assist your endeavours in finding the most cost effective solution for your validation requirements. Over the past decade 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 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 the vast field experience of its multi-disciplined 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.

Validation Online document package users confirm that they do routinely - Experience a 70% reduction in the cost of preparing validation plans and protocols - Also - Experience an 80% reduction in the time required to incorporate review comments: - Also - Experience a 95% reduction in the time required to raise supplementary protocols that are routinely required to plug omissions: - Also - Experience a 72% reduction in the time taken in getting their validation tasks to the execution of protocol stage - Also - Experience much greater confindence that their validation task will be completed within time and budget estimates - So alway remember - Using a validation package will ensure your validation task is properly defined, assessed, scoped and subjected to the appropriately intensity of qualification.

Need equipment validated 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 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.

Close to fifty percent of all regulatory compliance citations involve CAPA infringements in both the drug and device industries.
Are you absolutely certain your CAPA system is compliant?



If you are not absolutely certain, perhaps you should;



CLICK HERE TO DOWNLOAD YOUR OWN CAPA AUDIT PROTOCOL.

The Importance of Humidity Sensor or Hygrometer 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 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 600% 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.  When calibration is done in-house, the use of saturated salt solutions as a reference is a proven and affordable method.


Validation project or equipment to execute? Then use our most popular document suite. When you use our suite 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 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.

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.


- 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.

- 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.
- 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.
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
- 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.
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.
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.



CLICK HERE FOR FURTHER DETAILS OF DOCUMENTATION AVAILABLE
Copyright © 2005

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.

Quantity

.......................................................

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.

Quantity

.......................................................

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.

Quantity

.......................................................

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.

Quantity

.......................................................

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.


Quantity

.......................................................

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.

Quantity

.......................................................

Performance Qualification (P1Q) (Issue 5.) -- $89.00

The Performance Qualification is the last of the qualifying tests that equipment and processes are subjected to, prior to the actual first product run. It maybe that there are some steps in the process that can only be verified by actually running them (quick freezing and sublimation, to mention only two) or it sometimes is the fact that the product is a very expensive product, and cannot be wasted. So no one wants to run the process with product, until they are completely certain there will be minimal waste. Template for VMP.

Quantity

.......................................................

Process Qualification (P2Q) (Issue 3.) -- $85.00

The Process Qualification is the culmination of the validation process. The protocol is used in conjunction with the SOP for the process, to run three batches through the process being qualified and verify that the process consistently produces product to within the process specified tolerances. The results of the process must be recorder and reviewed with a view to ensuring that the deviancies (within permitted tolerances) that exist are random and not a trend that will lead to out of specification produce being produced.

Quantity

.......................................................

Validation Risk Assessment (Issue11.) -- $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 activities.
This VRA now includes the assessment table for categorising 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. Template for VMP.(now mandatory).

Quantity

.......................................................