More IQ/OQ/PQ Protocols.
Corporate Quality Manual
This Corporate Quality Manual (CQM) is the top tier of our documentation system. It gives an overview of our Quality
System. It is supported by corporate and
division standard operating procedures (SOPs) which are the second tier of our
Quality System documents and are listed in this Quality Manual. The third tier of the documentation system
consists of manufacturing / documents, forms & specifications developed
by each operating unit.
Qualification (Issue 5) -- $115.00
The Standard Operating Procedure attached to this generic design
qualification protocol, will chapter by chapter, take you through the task of
raising a fully detailed document. The main body is split into fourteen tables,
each one probing the design requirements and standards for the individual
requirement. Safety and security along with user operability are very detailed.
The document will lead you through all these design aspects allowing you to
delete some you feel are not important to your equipment. It is an easy
document to use and will ensure that you’re DQ’s are relevant, up to date and
easy to execute. Practically all the requirements are in table form. Allowing
fast and clearly presented results to be obtained
12000002_VrrP_Equipment_iss-4. -- $298.00
This Validation Risk & Requirements Plan (VrrP) is one document
designed specifically to replace three. The contents of the three original
documents were completely revised and edited into a more compact and
interactive format. Resulting in the document becoming notably easier to
use and quicker to review and amend. This new format will make a very
significant difference to the man hours required to produce and execute these
documents. There will also be a very noticeable reduction in the time
required for the reviewing and approving tasks. This new document titled
the VrrP replaces the VP, VRA & URS and now compliments our equally new 4Q
Protocol, which integrates the DQ/IQ/OQ/PQ into one document.
12000006_4Q_Equip_iss-4. -- $298.00
4Q Equipment Validation4u Protocol (4Q-Equip) has been designed
specifically to replace four standard protocols. By taking the
contents of the four protocol and carefully weaving them into one notably easy
to use protocol, we have made a significant advance in the task of streamlining
validation4u documentation by reducing protocol numbers by close to 75%. The
new bang up to date 4Q protocol replaces the DQ, IQ, OQ & PQ and now
compliments our equally new VrrP Protocol. By integrating the old style
DQ/IQ/OQ/PQ into one 4Q document there will be enormous savings in man hours in
the authoring, reviewing, updating and approving tasks.
For everyone's convenience, it is still written in word and compliant with FDA GMP Part 11 legislation.
12000008 4Q Equip Package $499.00
This quite unique two
document package is all that is required to fully validate; to cGMP standards,
equipment used in a regulated facility. A lot of effort has gone into ensuring
that repetitive instructions and actions have been designed out and innovative
and intuitive risk-based methodologies have been incorporated.
Both documents are prefaced with a methods' Standard Operating Practice (SOP)
document. These SOP’s lead you through the task of converting these highly
detailed templates into your very own company bespoke protocols. The hyperlinks
and cross-references within the package are; not only unique but also highly
cost-effective and intuitive to use. Each document is preloaded with the test
scripts (complete with acceptance criteria). All test and inspection scripts
are written in MS word, to facilitate simple editing of text, layout, tables
and schematics and are compliant with FDA GMP Part 11 regulations.