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.
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.
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
,
VRAand
GxP documentation for each and every validation project you areinvolved 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, genericInstallation
Qualification Protocol (IQ) or Operational QualificationProtocol (OQ) directly
from Validation Online, auto populate it inminutes, run through the attached SOP
and transform the document intoyour own bespoke company document in 20 minutes,
complete remainingrequirements in 30 minutes, and issue for approval signatures,
all inless than 60 minutes. Repeat this process for many other
regulatoryrequired 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.
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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