| Back to Back Issues Page |
 |
|
Laboratory Equipment Validation. August 22, 2012 |
Laboratory Equipment Validation.Validation Online’s combined IQ/OQ/PQ protocol was specifically designed to be used for laboratory type equipment. This document contains three protocols which collectively have approximately thirty inspections or tests that must be executed to verify that the item under qualification is used, operates and performs in a manner that satisfies all the appropriate requirements as detailed in the relevant User Requirements Specification (URS), cGMP’s and your company practices and procedure rulings. All companies carryout routine calendar based qualification and requalification functional testing of stand-alone laboratory type equipment. Unfortunately most of this testing is documented in a manner that is not compatible with basic FDA validation protocol standards. If a little time was spent on revamping these test documents standards, (changing the template would only have to be done once) a format could be used that would enable all such testing to be included in any validation requirement. Since regulators already accept the concept that unnecessary retesting should be avoided whenever possible. It follows that since all other tests in our protocols are fully written up, if the routine functional testing was of the right format then a recently executed routine or commissioning test could be reviewed and commented on in any validation protocols, as an alternative to repeating all the associated testing. This would result in the time line and cost of validation for this equipment being greatly reduced. Click here to view the FDA requirements for protocol testing formats and wording. Click here to access the Combined IQ/OQ/PQ protocol details. Bottom of Form Climatic Zone Validation Package-2 (Issue 3) This package is complete with all the validation documentation you require to validate the climatic condition within a warehouse a room or a large cabinet. Documentation includes our interactive and detailed Validation Plan (VP) the Validation Risk Assessment (VRA) the really easy to use Installation Qualification (IQ), the Operational Qualification (OQ) and finally the Performance Qualification (PQ). Along with the documentation are 10 highly accurate and easy to use data loggers ready to monitor and record close to 17K (each) parameters over what ever time base you select. This is now the simplest most expedient and most cost effective method of validating the climatic condition within any climatically controlled zone. Bottom of Form Climatic Zone Validation Package-1 (Issue 1) This package is complete with all the validation documentation you require to validate the climatic condition within a warehouse a room or a large cabinet. Documentation includes our interactive and detailed Validation Plan (VP) the Validation Risk Assessment (VRA) the really easy to use Installation Qualification (IQ), the Operational Qualification (OQ) and finally the Performance Qualification (PQ). Along with the documentation are 10 highly accurate and easy to use data loggers ready to monitor and record close to 17K (each) parameters over what ever time base you select. This is now the simplest most expedient and most cost effective method of validating the climatic condition within any climatically controlled zone. Combination
IQ/OQ/PQ
Protocol. 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 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. 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. Free Validation Document Downloads Click Here for further details of CAPA AUDIT document. VALIDATION ON LINE DOCUMENT STORE |
| Back to Back Issues Page |