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Edit Computer Qualification Template into Protocol

Computer Qualification Template Rationale.

Computer qualification template starts with a unique three level User Requirements Specification (URS) document. Since most documents; post the URS, will either fully, or partially, base their contents on the URS, it is essential that this document clearly, concisely and in a manner that is testable, specifies the exact requirements of the end user. It is also essential that these exact testable requirements remain attributable through the development of the Design Specification (DS) to the actual lines or groups of lines of code that enable them.

The Validation Master Plan - VMP, must be specific about this and all cGMP requirements, and instruct all personnel involved in the computer qualification program, of the importance of maintaining this traceability through the Installation Qualification - IQ - Operational Qualification - OQ - Performance Qualification - PQ.
Traceabilty of the URS functionality, to lines of code is an essential element in computer qualification. Once this traceability is established future maintenance and modification of software is made much simpler and more manageable.

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Computer Qualification Template and GAMP.

This graphic is of a Pen used in computer qualification.

The guide-lines laid out in Good Automated Manufacturing Practices  GAMP 5 , for the computer qualification template of automated systems including automatic computerized manufacturing equipment, control systems, automated laboratory systems, manufacturing execution systems and computers running laboratory or database systems. These computerized systems generally consist of the hardware, software and netware components, together with all control functions and GAMP 5 is a useful guide in scoping your validation online activities for such systems. It must be remembered at all times that GAMP is collective ideas from the computer qualification industry and does try to be all things to all people.

Which at times means certain sections can appear to contradict other sections. On a recent project when a group was set up to develop a Risk Assessment (RA) document from GAMP 5, after four weeks they were still divided and unable to reconcile their company's requirements with the alternative strategies given in GAMP. It bodes well to never forget that GAMP 5 is a guide from the end users point of view. The actual legal requirements come from the regulators, and obviously take precedence. Validation Online's computer qualification Template   protocols start with the development of a detailed three layer URS and progress through the VMP - IQ - OQ - PQ. Each of these documents are interactive fully detailed and simple to use. Each are preceded with an SOP which guides the user through all phases of protocol generation completion.

The verification that the end users requirements, as detailed in the URS have been fully satisfied, is paramount to the equipment being correctly qualified. Often this is hard to verify since the traceability from URS functionality to the actual hardware or software utilized is lost in the various specification designations that range from the functional specification to the design specification to code requirements. However unless the effort is made to maintain this traceability , validation is flawed and future maintenance and or modifications can become extremely problematic.

The Validation Master Plan - VMP, must be specific about this traceability requirement and ensure that all personnel are aware of the importance of maintaining it.

Qualification Tests and Interpretations.

In computer qualification a code verification solution that includes abstract interpretation can be instrumental in assuring software safety and a good quality process.

Dynamic Testing.

Dynamic computer qualification template verifies the execution flow of software, including decision paths, inputs, and outputs. Dynamic testing involves creating test cases, test vectors and oracles, and executing the software against these tests. The results are then compared with expected or known correct behavior of the software. Because the number of execution paths and conditions increases exponentially with the number of lines of code, testing for all possible execution traces and conditions for the software is impossible. Static Analysis.

Code inspections and testing can reduce coding errors; however, experience has shown that the process needs to be complemented with other methods. One such method is static analysis. This somewhat new method largely automates the software verification process. The technique attempts to identify errors in the code, but does not necessarily prove their absence. Static analysis is used to identify potential and actual defects in source code. Abstract Interpretation Verification.

A code verification solution that includes abstract interpretation can be instrumental in assuring software safety and a good quality process. It is a sound verification process that enables the achievement of high integrity in embedded devices. Regulatory bodies such as the pharmaceutical regulators.

Revalidation Scheduled.

There is no regulatory requirement to re-validate a process as long as that process operates in a state of GMP control and no changes have been made to the process or output product, the process does not have to be revalidated. Whether the process is operating in a state of control is determined by analyzing day-to-day process control data and any finished device testing data for conformance with specifications and for variability. Revalidation on Relocation.

When equipment is moved to a new location, installation and operation should be re-qualified. By comparing data from the original installation and operation qualification (IQ and OQ) and the repeat of all computer qualification template activities, the manufacturer can determine whether there have been any changes in equipment performance as a result of the move. Changes in equipment performance should be evaluated to determine whether it is necessary to revalidate the process. Revalidation Justification.

Part 820.75 of the QS regulation requires that validated processes be monitored and controlled so that when changes or process deviations occur, a manufacturer will know to review and evaluate the process and perform revalidation when appropriate. 21 CFR 820.75 (c) requires you to have documented procedures in place for evaluating; when revalidation is required. Procurement and Validation.

Recent research has highlighted that in the pharmaceutical and bio-medical industry, thirty two percent of all equipment procurement's are unsatisfactory. The major problem has been identified as companies not specifying in sufficient detail and or accuracy, what their actual needs are. The lack of a quality company approved User Requirements Specification (URS), leads to many companies having to resort to otherwise unnecessary and costly retrospective actions in modifying the equipment or producing unspecified documentation or engineering drawings, post procurement. These extraneous GMP requirements often cost more than the original equipment.

This graphic is a schematic of document inter-relationships for computer qualifcation.


Computer Qualification Template User Requirements.

In computer qualification these requirements must be set out in a manner that is none ambiguous, clear and easy to understand.

The Software User Requirements Specification (SURS) document should contain a written definition of the software functions. This must define the functionality that the end user requires from the system. These requirements must be set out in a manner that is none ambiguous, clear and easy to understand. Further to this the requirements must be grouped or worded in a manner that renders them testable and verifiable. It is not possible for computer qualification template to be properly executed without having predetermined and documented software strong requirements to validate against. Typical software requirements specify the following:

a) All software System inputs;

b) All software System outputs;

c) All functions that the software system will perform;

d) All computer qualification template performance requirements that the software will meet.

e) The definition of all external and user interfaces.

f) How users will interact with the system;

g) What constitutes an error and how identified errors should be handled.

h) Required response times;

i) The intended operating environment for the software.

j) All ranges, limits, defaults, and specific values.

k) All safety specifications & features.

GAMP 5 Software Categories .

Schematic listing all GAMP classification used in computer qualification.

Automated processes: When computers or automated computerized data processing systems are used in any way which can affect the quality, efficacy or regulatory records of a regulated product or process, the manufacturer must carryout computer qualification template of the software and hardware that make up the system. Post computer qualification template; proposed software and or computer changes must be approved prior to installation, and the validation status re-established post installation. These activities must be adequately documented.

Computer Qualification template System Design & Testing

In the diagram below it can readily be seen that the URS , along with the computer qualification template requirements; as given in the VMP , come together to form a document package consisting of the DQ , IQ , OQ and PQ from which the vendor can develop a fully legal and compliant product. Computer qualification template activities are grouped in two colors (orange and blue). The blue color is the requirement for standard computer qualification.

Graphic block display of the validation qualification document system.


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Validation Risk Assessment (Issue 11) $125.00

Risk Mitigation in Validation template (Issue 11) $125.00 The Risk and Part 11 Validation Risk Assessment(VRA) protocol is becoming the most important document in the validation online train. The VRA 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 is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your Risk Mitigation in Validation template.

This VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records. (now mandatory).

Combined IQ-OQ-PQ Computer (Issue-4) $159.00

This Pharmaceutical Validation combination protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’. It has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment and associated standard operating procedure TEMPLATE. The associated medical device validation  Master Plan template is interactive, easy to use and suitable for all mixes of equipment with and without software. Where temperature mapping is required it will included in this section. This of course may well be a Risk Mitigation in Validation risk Assessment template. As per 21 CFR Part 11.

The Installation Qualification Template or IQ section establishes documented verification that all medical device validation template online executables are catered for and that key aspects of the equipment Qualification adhere to approved design Qualification template and the recommendations of the manufacturer have been suitably considered. The Operational Qualification Template section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documented process validation A executables to demonstrate this. The PQ section develops documented evidence that all the requirements specified in your corporate validation 4U manual have been verified as operating consistently and exactly as specified in the medical device validation template; The User Requirements Specification template 

Installation Qualification. SOP & Protocol (Issue 9.) $115.00 10000020

The Standard Operating Procedure template (SOP) used to generate this installation Qualification template (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 template. 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, whether for current Good Manufacturing Practice use medical device use or a simple installation qualification template. 

Operational Qualification, SOP & Protocol (Issue 10.) $115.00 

You will find this validation online intuitive Operational Qualification template (OQ) delightfully simple and straightforward to use, as it takes you through the process of customization of your Operational Qualification Protocol template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific 21 CFR Part 11 compliant Installation  Qualification Template. The OQ template comes complete with all the standard test scripts, more specialist test scripts can be found listed below. These can easily be pasted into the standard OQ, allowing you to quickly build your own fully detailed and referenced company bespoke Operational Qualification Protocol, along with the installation qualification template.

Computer Combined IQ-OQ-PQ (Issue 3) - $ 159.00

This combination protocol has been produced in response to several hundred reader suggestions we received in our 'Suggestions Section'. It has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment. It is interactive, easy to use and suitable for all instances where computer QUALIFICATION TEMPLATE is required..

Computer User Requirements Specification (Issue 5.) - $ 115.00

The document that sets the standard, and specifies your computer Qualification template n 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

Computer Validation Master Plan (Issue 5.) - $ 89.00

The Computer Qualification Template  (Validation) Master Plan, is the starting point for validation, and hence the most important validation document. It greatly improves validation efficiency 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.

CSV Design Qualification (Issue 3.) - $ 89.00

The Standard Operating Procedure attached to this generic computer qualification template 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. Practically all the requirements are in table form. Allowing fast and clearly presented results to be obtained.

CSV Installation Qualification (Issue 6.) - $ 89.00

Computer Qualification template (CIQ) is an important step in the overall validation and computer  qualification process for software and computer systems. Our protocol leads you through the detailed requirements.

CSV Operational Qualification (Issue 6.) - $ 115.00

Computer Qualification Template (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.

Computer Performance Qualification (Issue 7.) - $ 87.00

The Computer Qualification  template 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.

Computer Vendor Audit (Issue 3.) - $ 105.00

This Computer Vendor Audit document should be customized using the built in tools. The document can then be targeted 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. This enables your assessment to be expressed simple and clearly as a percentage, allowing clear unambiguous comparisons to be presented for competing companies.