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The standard operating system used throughout industry for spreadsheet applications is Excel. Excel is a well used and known system with millions of programs in use word-wide. As such it does not require to be validated. However applications that run on Excel do require to be validated. Just like any other software program the degree and scope of validation depends entirely on the risk or possibility that the application can affect product quality, efficacy or records. Regulators expect you to be able to demonstrate that your spreadsheets are functioning correctly and consistently produce accurate data. If you cannot show with documented test evidence that this is the case, then your regulators or auditors can stop you using your spreadsheets or worse still stop your operations until the situation is resolved. Validation Online offer a complete suite of validation documents from the Validation Plan (VP) to the User Requirements Specification (URS) to the Validation Risk Assessment (VRA) and culminating in a combined Installation / Qualification / Performance Qualification (CSQ) protocol. These documents are newly and specifically designed not only to qualify your existing spreadsheets, but to ensure that all your future spreadsheets are designed to be fully compliant.
Spread sheet Validation Package. (Issue-1) -- $445.00
Validation Risk Assessment (Issue10.) -- $125.00 This popular Validation Risk Assessment (VRA) has now been edited and enlarged to include Part 11 assessment tables for you to use in classifying which of your predicate records require to be stored in compliance with 21 Part 11, and which do not. It also includes an Excel spreadsheet to allow you to establish a permanent record of all such judgements, as is now mandated by the regulatory authorities.
Combined IQ / OQ Protocol. New from Validation Online a Combined almost ready to use; IQ-OQ protocol. Designed to cover equipment in general and specifically laboratory type equipment, with or without embedded or programmable software. This is not a list of chapter headings. It is a fully detailed interactive IQ and OQ protocol. Humidity sensors require frequent calibration and continual monitoring, they are, along
with pH sensors, the most prone
to error sensors in general facility use. They should be calibrated against a
range of Chemical mixtures that establish a specified humidity calibration level
in small atmospheric containers. These chemical mixtures are
issued with UKAS traceable humidity
calibration certification. They are supplied in a kit that
includes three certified standards covering the low mid and high sectors of the
relative humidity calibration percentage range. The kit includes three ready to use enclosures (with certification
of their values), a range of adaptors to suit your sensors, a sample FDA compliant calibration certificate and a
complete detailed method statement on exactly what to do. All
these items are contained in a robust neat and easy to handle carrying case. To read more or purchase your test kit please click on
link below. With HEPA filters, the manufacturers recommended dirty filter
change pressure differential (PD), is only correct if the filter is used at
exactly the the same air flow as the makers specify. If there is any digression
(there is often as much as 50% digression) then the makers PD must be corrected.
If this is not carried out you can compromise the integrity of your room /
machine pressure regimes. As you are no doubt aware this would be a very serious
state to be in. There are also health and safety problems that can arise, if
personnel are not getting the air flow protection that is sometimes designed
into the system. This test script is not in the standard OQ, and is only
available here as a download. Regulators ask to review your writen
justification for these filter change PD's; make certain you have
them. |