we have listed the top seven topics that we receive continual queries
testing verifies the execution flow of software, including decision paths ,
inputs, and outputs. Dynamic testing involves creating
test vectors and oracles, and executing the
software against these tests. The results are then compared with
known correct behavior of
software. Because the number of execution paths and
increases exponentially with the number of lines of code, testing for
possible execution traces and conditions for the software is impossible.
Code inspections and
testing can reduce
coding errors; however, experience has shown that the process needs to
complemented with other methods .
One such method is static analysis.
This somewhat new method
largely automates the software
verification process. The
technique attempts to identify errors in
the code, but does not
necessarily prove their absence. Static analysis is
used to identify
potential and actual defects in source code.
A code verification solution
that includes abstract interpretation can
instrumental in assuring software safety and a good quality process.
It is a sound verification process that
achievement of high integrity in embedded devices. Regulatory bodies such
regulatory requirement to re-validate a process as long as that process
operates in a state of GMP control
and no changes have been made to
or output product,
the process does
not have to be revalidated. Whether the process is operating in a state
control is determined by analyzing day-to-day process control data and
finished device testing data for conformance with specifications and
equipment is moved to a new location, installation and operation should
re-qualified. By comparing data from the original installation and
qualification (IQ and OQ)
and the re-qualification, the manufacturer can
determine whether there have been any changes in equipment performance as
a result of the move. Changes in equipment performance should
be evaluated to determine whether it is necessary to revalidate the
the QS regulation
requires that validated processes be monitored and controlled so that
changes or process deviations occur, a manufacturer will
know to review and
evaluate the process and perform revalidation when
CFR 820.75(c ) requires you to have documented procedures in
place for evaluating; when revalidation is required.
research has highlighted that in the pharmaceutical and bio-medical
thirty two percent of all equipment procurements are
major problem has been identified as companies not specifying in
detail and or accuracy, what their actual
needs are. The lack of a quality company approved User
Specification (URS) , leads
companies having to resort to otherwise un-necessary and costly retrospective actions
in modifying the equipment or producing unspecified documentation or
engineering drawings, post procurement. These extraneous GMP
cost more than the equipment.
combination protocol has been produced in response
to several hundred
suggestions we received in our ‘Suggestions
Section’. It has been carefully
designed to make it the preferred choice for Process and Laboratory
equipment. It is an interactive, fully detailed, sixty three page
runs to approximately seven thousand words. It is presented in 'MS
facilitate ease of final editing by the end user. It has become a very
Protocol (Issue-2). -- $159.00
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 them.
Purchase your copy of this test script now at Special Price of $16.00.