Validation Online.index

This document follows our proven practice of supplying a generic document frame with an automatic method of populating it. Once populated, all you are required to do is follow the attached SOP as it takes you through a process section, by section, that changes your generic document into a detailed, referenced, bespoke company document. The document follows our three level URS system that ensures functionality traceability from the URS to the various testing protocols. A great document to author and use. This document interfaces with our Risk impact assessment (RIA), Validation Project Plan (VP), User Requirements Specification (URS), giving a seamless flow from Corporate Practices and Procedures - VMP - VP - IQ - OQ - PQ, while integrating flawlessly with the URS - DQ - RIA.

This Matrix must sit along side your VMP or PVP and together with these documents give a very concise overall picture of your validation program. This four part matrix allows you to list all the equipment and systems that must be qualified. Each entry is allocated a row in the matrix. The row consists of eleven headings, these may be edited as required (but come with all the standard documentation titles inserted). In this matrix there is room to enter the document number, prefixed by, A to D. The document number gives you the instant cross reference to the current document, the A to D prefix shows the progress stage.

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This document should be customised using the find and replace word feature. The document can then be re-focussed to reflect your project priorities. The fifteen chapters all contain 10 questions, the total scored is then weighted to reflect your priorities. By assessing the importance of each of the chapter subjects in your project, the weighting is altered taking points from one and adding to others. For example in a recent audit, after weighting, order of priorities became; delivery number one, validation number two, and price trailing at number nine. The document has been used to audit major and minor manufacturing and support companies. It is a very searching audit tool, and completely removes the possibility of suggestions that personal biases and opinions influenced the final audit decision. When you audit with this document; they know they have been audited.

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This document follows our well developed method of using a generic document and allowing the customer to apply an attached detailed SOP to it, turning the generic document quickly into a first class company bespoke document. This VP details and integrates all validation activities and procedures required for a small to medium sized project, involving production/facility/utility equipment using electronic controls or monitoring.

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The document that sets the standard, and specifies your requirements in a manner that ensures when a system or piece of equipment is selected, it will deliver the functions you want, it will have maintenance standards, it will have calibration records, it will have all the documents and records to enable successful validation to be completed. This document was designed to be used as a live document up until the DQ is completed and approved. It uses three levels of URS, URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the URS through to the final PQ and OQ functionality testing. A mandatory requirement for Full Life Cycle Validation of computer systems that are the subject of predicate rules. It can be used on mechanical, electrical and software controlled, monitored or driven systems.

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.

The Risk and Part 11 Impact Assessment(RIA) protocol is becoming the most important document in the validation train. The RIA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. This demands that your RIA document does not raise more questions than it answers. A robust and simple to execute document is required, one that will lead you through the process and deliver a result that can be used as the foundation of your validation activities.

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The SOP used to generate this IQ, takes you through the process line by line, chapter by chapter. It really is unique to find a SOP document so easy to use, all the work is done for you. All the documents are detailed, all the drawings listed and all the checks and tests detailed. The final product is a professional and comprehensive Installation Qualification Protocol. One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past. There is now no reason for not being able to produce 4 to 8, IQ protocols per 8 hour day.

This Operational Qualification SOP and Protocol, can be simply and quickly converted (using find replace techiques) into your own document. Following the attached SOP can further convert it into your completely bespoke Operational Qualification Protocol, speedily raised and ready to issue for approval signatures, prior to execution.

The Performance Qualification is the last of the qualifying tests that equipment and processes are subjected to, prior to the actual first product run. It maybe that there are some steps in the process that can only be verified by actually running them (quick freezing and sublimation, to mention only two) or it somtimes is the fact that the product is a very expensive product, and can not be wasted. So no one wants to run the process with product, until they are completely certain there will be minimal waste.

The Process Qualification is the culmination of the validation process. The protocol is used in conjunction with the SOP for the process, to run three batches through the process being qualified and verify that the process consistently produces product to within the process specified tolerances. The results of the process must be recorder and reviewed with a view to ensuring that the deviancies (within permitted tolerances) that exist are random and not a trend that will lead to out of specification produce being produced.

The cGMP Review is undertaken to ensure that a design and/or facility conforms to the cGMP requirements and is fit for purpose. The requirement for Regulatory Compliance will be established during the proposal preparation.
cGMP Reviews should normally take place in accordance with the project programme. The initial cGMP Review should take place immediately after the project initiation, to define the cGMP Envelope and clarify the cGMP requirements. Additional cGMP reviews should be held towards the end of the front end design and detailed design.
It is good housekeeping practice for department heads to instigate periodic cGMP walk rounds to analyse, document and ascertain if everyday wear and tear to the fabric of the facility, is compromising the validated status of the facility.

The ever sought after SOP for writing an SOP. Adopting a standard format throughout a company for the easy authoring of SOP's is of immense benefit to everyone that has to use them. Our format follows our standard company developed format of a generic template prefixed by an SOP. Follow the SOP and you quickly and simply produce a sound compliant SOP document. In this case the generic SOP template is prefixed by a SOP, follow the SOP and you complete your SOP. Sound confusing ! not really, just nice, easy and quick to use.

The Gap Analysis tool allows you to systematically challenge the company’s cGMP policies and procedures, comparing them with the regulatory expected standards and allowing you to draw up a list all delinquencies. Until you can highlight the company’s deficiencies, you are not able to scope the task of becoming compliant. It really is impossible to put resources together for an unmeasured task.

Steam Quality Validation. This a high quality protocol listng all component parts required for setting up and executing of the three main steam quality tests. All the operator has to do is use the auto fill function to personalize the PQ, then follow through the detailed test methods recording the results as they go.
A continuous supply of saturated steam is required for steam sterilization. Too high a level of non condensable gases will prevent the attainment of sterilization; too little moisture carried in suspension may allow the steam to become superheated during expansion into the chamber, while excess moisture may cause damp loads. Where steam systems are either routinely or irregularly shut down, large quantities of air will be present in the distribution system on restarting. It is recommended that in such circumstances a comprehensive and validated venting procedure should be applied and testing for steam quality is appropriateFor Steam Quality Validation.

The Computer Validation Master Plan, is the starting point for validation, and hence the most important validation document. It improves validation efficiency greatly by forcing all concerned to document, review, and discuss, the proposed methods and allotted responsibilities. It is an expected document with the FDA, and a mandated document with the EU.
While in the past computer validation was more focused on functions of single user computer systems, recently the focus has progressed into network infrastructure, networked systems and on security, authenticity and integrity of data acquired and evaluated by computer systems.
However never forget that a piece of equipment is purchased and used, for a purpose, and that purpose is set out in the purchaser’s User Requirements Specification (URS). Therefore the first and foremost requirement for any piece of equipment, is the verification that it satisfies the requirements specified in this URS.

This Computer Vendor Audit document should be customised using the find and replace word feature. The document can then be re-focussed to reflect your project priorities. The fifteen chapters all contain 10 questions, the total scored is then weighted to reflect your priorities. By assessing the importance of each of the chapter subjects in your project, the weighting is altered taking points from one and adding to others. For example in a recent audit, after weighting, order of priorities became; delivery number one, validation number two, and price trailing at number nine. The document has been used to audit major computer equipment suppliers including two of the major DCS system suppliers in the petro/pharma/bio world. Use it wisely it is a very searching audit tool, and completely removes the possibility of suggestions that personal biases and opinions influenced the final audit decision. When you audit with this document; they know they have been audited, and you have the documented information to advise your company or client on the suitability of the vendor.

Quantity

This document follows Validation Onlines's standard method of using a generic document and allowing the customer to apply an attached detailed SOP to it, turning the generic document quickly into a first class company bespoke document. This CSV VP details and integrates all validation activities and procedures required for a small to medium sized project, involving production/facility/utility equipment using electronic controls or monitoring.

Quantity

The document that sets the standard, and specifies your computer requirements in a manner that ensures when a system or piece of equipment is selected, it will deliver the functions you want, it will have maintenance standards, it will have calibration records, it will have all the documents and records to enable successful validation to be completed. This document was designed to be used as a live document up until the DQ is completed and approved. It uses three levels of CURS, CURS Level 1, 2 and 3, and is the only URS to guarantee traceability from the URS through to the final PQ and OQ functionality testing. A mandatory requirement for Full Life Cycle Validation of computer systems that are the subject of predicate rules. It can be used on mechanical, electrical and software controlled, monitored or driven systems.

The Standard Operating Procedure attached to this generic computer design qualification protocol, will chapter by chapter take you through the task of raising a fully detailed protocol. The main body is split into fourteen tables, each one probing the computer 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 computer 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.

Installation Qualification (IQ) is an important step in the overall validation and qualification process for software and computer systems. Our protocol leads you through the detailed requirements. GAMP 4, is used as a general guide, however there are some areas where it is better to stick with the FDA interpretations. Validation Online has extensive validation experience, where we know that there is a regulatory sensitive area we make absolutely certain that our documentation is clear, concise and supplies the information the regulators are anticipating. These protocols have evolved over 15 years use in the pharmaceutical and allied industries.

Operational Qualification (OQ) is an important step in the overall validation and qualification process for software and computer systems. Our protocol leads you through the detailed requirements, progressively and simply. GAMP 4, is used as a general guide, however there are some areas where we find it preferable to stick with the FDA interpretations. Validation Online has extensive validation experience, where we have found over the years, on the regulatory debriefs, that there are certain presentations that they prefer, we have always been quick to comply. Just as with the IQ, this OQ has evolved over 15 years and countless regulatory reviews.

The Computer performance Qualification is the culmination of the validation process. The protocol is used in conjunction with the system operating SOP, to verify that the system process is consistent and correct. The results of the testing must be recorder and reviewed with a view to ensuring that the deviancies (within permitted tolerances) that exist are random and not a trend that will lead to out of specification operation during production use.

Installation Qualification will confirm that; The title and version of the software is documented. The software has been loaded correctly. Specific site hardware items have been installed correctly. Power supplies, earth connections, and field connections are correct and enable the system to power up. Control and monitoring instrumentation are installed and have been calibrated. System functions operate on power up, and any built in diagnostics are satisfactory. Product contact material is acceptable. Drawing, documents, specification are all in place. 4.4 Electrical Conformance Verification (Minor). System Future Maintenance. Change & Consumable Parts.

Execution of the DCS Operational Qualification (OQ) will verify that; Radio Frequency Interference. Application Software Identification. 21 CFR Part 11 Conformance Verification. Equipment Function Test. Safety / Health / Environmental Assessments. Security of Back-up Software. Power failure Test. System Documentation (SOP Verification). Operating System Software. Test Equipment Calibration. 21 CFR Part 11 Eligibility Verification.

This HVAC Design Qualification along with the attached Standard Operating Procedure, 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 a superbly 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.

This superb combined HVAC SOP and IQ template makes it so easy for you to raise a quality IQ. With the new suite of HVAC documents from the DQ - IQ - OQ - PQ, all user freindly and ready to go, your validation life has got musch simpler. The final product is a professional and comprehensive Heating Ventilation and Air Conditioning Installation Qualification Protocol. One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past. There is now no reason for not being able to produce 4 to 8, IQ protocols per 8 hour day, or a complete suite in one day.

This superb HVAC Performance Qualification is the last in the chain of qualifying tests that HVAC systems are subjected to, before being considered qualified. However environmental qualification is required to confirm air quality and containment.

This package is targeted at the new build where the original design concepts are translated into a URS. From which the full flow of qualification documentation can be generated, and correctly cross referenced. This Validation Package contains one of each of these documents: