The easing of the requirements
detailed in 21 CFR Part 11, has lead to other requirements being mandated. These requirements are all detailed in
our up-dated Validation Risk Assessment document. The Validation Risk Assessment (VRA) is
now a pretty essential document to have and use.
To learn more about this Validation
Risk Assessment contents, click here; VRA
To purchase a ready to use
Validation Risk Assessment document, click here; VRA
It is a mandatory requirement that
certain aspects of this assessment are documented and held as a regulatory
required record. These are;
Does the software require full life
Does the software produce records
that must comply with 21 CFR Part 11?
If the data is definitely predicate
data; how is compliance achieved?
The answers to these questions are
required to enable the Validation Plan to provide sufficient information to the
protocol writers, to enable them to define the correct content for the IQ/OQ/PQ
VP is then used by the protocol writers as the official mandate for protocol
A recent warning letter demonstrates just how few companies use a Gap Analysis to validate that they are compliant. CAPA discrepancies continue to be the biggest single source of problems. However the daddy of them all recently has been a well known company that had carefully documented the levels of experience and educational standards required for various GMP sensitive roles (In accordance with GMP), only for the FDA to find the persons in these jobs were not qualified properly. (click here to read)
Do use a Gap Analysis and avoid these embarrassing events.
Gap Analysis Tool (Issue 2.) -- $115.00
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.
Are you ready
for an inspection?
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
Purchase your copy of this test script now at Special Price of