Computer qualification starts with a unique three level User Requirements Specification document (URS). 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 Functional Specification (FS) 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 URS functionality, to lines of code is an essential element in computer qualification. Once this traceability is establish future maintenance and modification of software is made much simpler and more manageable.
The guide-lines laid out in Good Automated Manufacturing Practices GAMP 5, for the computer qualification 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 system generally consists of the hardware,
components, together with all control functions and GAMP 5 is a useful
guide in scoping your validation activities for such systems. It must
be remembered at all times that GAMP is collective ideas from
the 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 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 requirement and instruct all personnel involved in the qualification program, of the importance of maintaining this traceability.
Dynamic testing 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.
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 re-qualification , 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.
The Software User Requirements Specification (SURS) document should contain a written definition of the software functions. This must define the functionallity 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 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 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 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 related requirements, specifications & features.
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 of the software and hardware that make up the system. Post computer qualification; 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.
In the diagram below it can
readily be seen that the URS, along with the and the details of computer qualification requirements as
given in the VMP,
come together to form a document package consisting of the DQ, IQ,
from which the vendor can develop a fully
legal and compliant product.
Computer qualification activities are grouped in two
colors (orange and
blue). The blue color is the requirement for
standard computer qualification.
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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 mixes of equipment with and without software.
Computer User Requirements Specification (Issue 5.) -- $115.00
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
Computer Validation Master Plan (Issue 5.) -- $89.00
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.
CSV Design Qualification (Issue 3.) -- $89.00
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. 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 Installation Qualification (CIQ) is an important step in the overall validation and qualification process for software and computer systems. Our protocol leads you through the detailed requirements.
CSV Operational Qualification (Issue 6.) -- $115.00
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.
Computer Performance Qualification (Issue 7.) -- $87.00
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.
Computer Vendor Audit (Issue 3.) -- $105.00
This Computer Vendor Audit document should be customised 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.