The Validation Plan (VP) must detail what you are going to do, who is going to do it, when, how and where they are going to do it. The User Requirements Specification (URS) must document exactly what the end user wants this equipment to do. The Design Qualification (DQ) will verify the design. Validation Risk Assessment (VRA) will define the depth of validation required and document the justification; a requirement mandated in CFR's. After this, the standard flow of documents is required - Installation Qualification (IQ), the Operational Qualification (OQ) and finally the Performance Qualification (PQ). This is now the simplest, most expedient and most cost effective method of validating a PLC. Each of these documents is mandated by cGMP's. There are no compliant short cuts. VP, URS, DQ, VRA, IQ, OQ, PQ. - - This package consists of one of each of these documents.

Unlike our normal validation packages this quite revolutionary 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.

This validation packages of documents is ideal for those who are in the procurement stage for one or more new or refurbished autoclaves. Follow the Validation plan (VP) and use it to ensure all eventualities in the procurement process are identified and planned for. Ensure resources are allocated for all minor and major support tasks. Use the DQ to verify that this design of autoclave is capable of fulfilling all your functional, GMP and safety requirements. If all your autoclaves are the same then one VP, DQ and URS may be all that is required. Then it is quite simple to copy over individual IQ, OQ and PQ protocols from the document package; which on execution will verify that all the requirements as documented in the URS have been fully satisfied.

This autoclave validation package contains: VMP, VP, URS, VRA, DQ, IQ, OQ and PQ.
Quantity

This is quite different from our usual validation packages, it is an evolutionary VrrP & 4Q protocol package comprising of only two documents that have been specifically designed to fully validate; to cGMP standards, equipment for use in a cGMP 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 VrrP & 4Q protocol package package are; not only unique but also highly cost-effective and intuitive to use. Each document is pre-loaded 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.

From 2013 the FDA designated 503B Dispensing Pharmacies as “Outsourcing Facilities” that may produce large batches of regulated product with or without prescriptions to be sold to healthcare facilities. 503B approved facilities are required to maintain full compliance with current good manufacturing practices (CGMP), I.E. the ensuing steps for dispensing, mixing or blending, filtration, compression or filling, container closure system (CCS) filling, coating, polishing, device filling, and packaging of a drug product must occur under a strict CGMP systems of controls. Validation Online has now released a package of validation documents designed specifically for validating such a 503B Dispensing Facility. The package consists of:-

VMP – VP – URS – DQ – VRA – IQ – OQ – PQ      503B-Dispen-Pharmacy-Validation-Pack $799.00

Out of all our validation packages this one is suitable for rooms or cabinets up to 10 cubic meters and arrives complete with all the validation documentation you require to validate the temperature condition within a warehouse a room or a large cabinet. Documentation includes our interactive and detailed Validation Plan (VP), The equally well detailed User Requirement Specification (URS), the Validation Risk Assessment (VRA). The Design Qualification (DQ) along with the really easy to use Installation Qualification (IQ), the Operational Qualification (OQ) and finally the Performance Qualification (PQ). Along with the documentation are ten, temperature easy to use data loggers ready to monitor and record close to 17K (each channel) 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.

Contains:- VP, URS, DQ, VRA, IQ, OQ & PQ.
10 off Temperature Data Loggers (Capacity 18k parameters). This is sufficient coverage to qualify a small vehicle with a temperature controlled volume of 1 to 2 cubic meters. Compatible with a 10 foot Reefer or container

Out of all our validation packages this package is suitable for rooms or cabinets up to 50 cubic meters and arrives complete with all the validation documentation you require to validate the climatic condition within a warehouse, room or a cabinet. Documentation includes our interactive and detailed Validation Plan (VP), the equally well detailed User Requirements Specification (URS), the Validation Risk Assessment (VRA) and the Design Qualification (DQ) along with the really easy to use Installation Qualification (IQ), the Operational Qualification (OQ) and finally the Performance Qualification (PQ). Along with the documentation are twenty temperature data loggers ready to monitor and record close to 17K (each channel) parameters over what ever time base you select.
Contains:- VP, URS, DQ, VRA, IQ, OQ & PQ.
20 off Temperature Data Loggers (Capacity 17k parameters). This is sufficient coverage to qualify a small vehicle with a temperature controlled volume of 5 to 25 cubic meters. Compatible with a 20 foot Reefer or container

This one of our validation packages is made up of six documents that make up the advertised document package.
THERE ARE NO DATA LOGGERS IN THIS PURCHASE.
The Validation Plan (VP) must detail what you are going to do, who is going to do it, when, how and where they are going to do it. The User Requirements Specification (URS) must document exactly what the end user wants this equipment to do. The Design Qualification (DQ) will verify the design. Validation Risk Assessment (VRA) will define the depth of validation required and document the justification; a requirement mandated in CFR's. After this, the standard flow of documents is required - Installation Qualification (IQ), the Operational Qualification (OQ) and finally the Performance Qualification (PQ). This is now the simplest, most expedient and most cost effective method of validating the climatic condition within any mobile container or vehicle body. Each of these documents is mandated by cGMP's. There are no compliant short cuts.
VP, URS, DQ, VRA, IQ, OQ, PQ. - - This package consists of one of each of these documents, but no data loggers.

The contents of this package includes quantity 30 off, single channel data loggers. Simple and robust to use; their use renders the whole validation task - much simpler. There needs to be a User Requirements Specification (URS) that will document exactly what the end user wants. The Design Qualification DQ will verify that the design is compliant with URS. This needs a Validation Risk Assessment (VRA) to define the depth of validation required and to document this decision; as is mandated in CFR's. After this, the standard flow of documents is required - Installation Qualification (IQ), the Operational Qualification (OQ) and finally the Performance Qualification (PQ). All these documents are fully detailed and are designed to be simple and expedient for the end-user to follow.
This is now the simplest, most expedient and most cost effective method of validating the climatic condition within any mobile container or vehicle body. VP, URS, DQ, VRA, IQ, OQ, PQ. - This package consists of one of each of these documents. Plus 30 off single channel temperature data loggers. This is sufficient coverage to qualify a small vehicle with a temperature controlled volume of 20 to 60 cubic meters. Compatible with a 40 foot Reefer or container

This is one of our validation packages that is a Bundle comprising of four SOP's namely - Calibration - Part 11 - Spreadsheets - GMP - These four SOP's have been bundled together to make a very attractive package. A package priced well below their individual cumulative costs. The four SOP's specifically target ares of GMP that are currently producing 76% percent of the adverse comments contained within FDA warning letters. Each SOP has been in use in the industry for in excess of twelve months.