Validation of all Critical Software.
Validation of product software
requires a document chain that starts in the initial stages with extraction from
the concept documentation of sufficient information to development a robust,
comprehensive and inclusive User
Requirements Specification (URS).
This URS must be reviewed and approved by all parties that will be
involved in the procurement, installation, training, use, maintenance,
calibration and regulatory compliance, to ensure that all the requirements
associated with the successful qualification of the equipment have been
identified, documented and provisioned for.
Once the equipment is in the qualified
state; all subsequent modification proposals must follow the same route and
intensity of investigation, identification and documentation, prior to being
approved for execution. Once
approved has been attained; a Validation
Risk Assessment (VRA) must be used to set and justify the scope of
revalidation that the incorporation of the modification demands.
Every month there is fresh evidence;
in the form of FDA Warning Letters, that scream out that many companies are
either not aware of this requirement, or perhaps opt to ignore it. A sample warning letter is reproduced
Validation of software was not performed. Specifically, the
Integrated analyzers in commercial clinical use have either a VME Motorola ICS
board or a PowerPC board running the software. When validating the software
version change; your firm did not do system integration testing on the VME
board. Neither did it conduct a code review of the software change for the VME
board. The modified version was then released to the field in late 2009. It was
subsequently determined that this software had a bug introduced by the change
and a recall was necessary in February 2010. (FDA
The above Warning Letter is seriously
bad news for any company. To recall
(in an accountable manner) every single item of product from warehouses,
shippers, distributors and retailers, world-wide is an extremely costly
operation. However if the product
is an implanted device the costs may well escalate exponentially.
It bodes well to always be aware that
software to be used in any; regulated manufacturing process, which
has been rated (using an official VRA) as critical to the quality of that
process or predicated records of that process, requires to be subjected to the
same procedure listed above.
Combined IQ/OQ/PQ Equipment Protocol (Issue-2). -- $159.00
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
Combined IQ-OQ-PQ Computer Protocol (Issue 3) -- $159.00
Software Validation SOP (Issue-2) -- $22.00
Software Validation Master Plan (issue-2) -- $115.00
Software Validation Risk Assessment (Issue 2) -- $125.00
Software User Requirements Specification. (Issue 2) -- $115.00
Software Validation Plan (Issue 2) -- $89.00
Software Design Qualification. (Issue 2) -- $89.00
Software Installation Qualification. (Issue 2) -- $89.00
Software Operational Qualification. (Issue 2) -- $89.00
Software Performance Qualification. (Issue 2) -- $89.00
Software Validation Package (Issue 1) -- $699.00
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.