Software Validation commences with a user requirement document (URS). When either management by policy; or an employee by cause; requests that a controlled process is instigated or an existing controlled process requires a serious modification (miner modification would be controlled under change control ), a User Requirement Specification (URS) document is raised. Over the course of several meeting the URS is fleshed out to document all aspects of the requirement. It is essential that the document is properly scoped in order that the procurement , installation, commissioning, validation, user training, maintenance, calibration and cleaning tasks are all investigated and defined adequately.
To scope and define an adequate validation procedure the URS has to be detailed sufficiently for various assessments to be made. The main assessment that concerns us with qualification documentation is the risk assessment. This assessment is only concerned with ensuring that the degree of validation that is proposed; is compliant with the regulatory requirements.
So at this early stage it is required to execute a Validation Risk Assessment protocol against the end user's requirements. This step is purely to ensure that the more obscure pieces of ancillary equipment and support services are fully understood and their requirement investigated, priced and included in the final issue of the URS; which will be sent out with the Request to Tender. This is an essential stage if the URS is to accurately define what depth and scope of validation is appropriate for the verification that the software will deliver all the requirement detailed in the URS.
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It is a mandatory requirement that certain aspects of this assessment are documented and held as a regulatory required record. These are;
Does the software validation require Full Life Cycle validation ?
Does the use of the software produce records that must comply with 21 CFR Part 11 ?
If the data requires to be Part 11 compliant, how is that to be being achieved?
The answers to these questions are required to enable the Validation Plan (VP) to provide sufficient information to the protocol writers, to enable them to define the correct content for the Installation Qualification (IQ). Operational Qualification (OQ) and the Performance Qualification (PQ) protocols.
The outcome of the VRA drives a split in software validation documentation scope, if the VRA categorizes the software validation as requiring Full Life Cycle
(FLCV); then a considerable amount of the
software validation effort is put into establishing how the software originated, was designed
and developed, in order to establish that its basic concept and development can
be considered robust , sound and in accordance with best
The original development plans
, code reviews, methods reviews and testing plans must be available to enable this software validation documentation to be executed successfully. Once this proof of quality build is
establish, validation then follows a more convention path in code / procedural /
security verification / functional inspections and
Software that is not classified as requiring FLCV
treatment, does not require this depth of verification into quality build history and is validated mainly by the more convention path in code / procedural / security verification / functional inspections and verification's.
The SOP for Software Validation documentation continues to be an extremely popular document. This document leads you through the validation process, from the URS to the final P2Q.
SOP for Software Validation (Issue-1)) -- $22.00
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.
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 qualification 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.
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 FDA and some segments of industry recognize the value of sound verification principles and are using tools based on these principles.
These must be based on the functionality as the end user will see it. They must cover all aspects of using the program and be sufficiently detailed to enable the development team to clearly and concisely understand what the future product plans are.
This stage develops and expands the end user’s requirements, and drills down to a sufficient level of detail required for the development team. As each detailed requirement document is completed, it is subjected to peer review and acceptance by a representative from development, quality assurance, architecture, product management, and development management.
Based on the high level requirements (URS level 1 ), establish a suitable product architecture taking the end user requirements and the required functionality requirements into account. This task should be structured in parallel with defining the detailed requirements.
The source code development team executes the detailed requirements and the technical architecture. This process is best commenced only when both parts of the requirements document have been completed, reviewed and approved.
The QA team must sit in at all stages from conception to completion and hand over to end user. They are not there to review the software. They are there to ensure that best industry practices are used and that company software policy and procedures are strictly adhered to. They will ensure that the program created by the development team meets the defined requirements and is supplied to the end user complete with all necessary support documentation. They will ensure the source code is installed and used in accordance with company requirements practices & procedures, and all relevant cGMP regulations.
It now appears that the current FDA Guidance rules pertaining to 21 CFR Part 11 may be with us for a longer time than was originally anticipated. So we have incorporated the guidance suggestions in their latest guidance document, into this Validation Risk Assessment (VRA) (now issue 10). This VRA document now comes with a downloadable matrix for registering the justification for all your Part 11 assessments. This is now a mandatory requirement.
11 will be interpreted narrowly; we are now clarifying that fewer records will
be considered subject to part 11. (extract
from FDA document)
This would appear to mean that the original all embracing approach to all electronic records is to be dropped and the rigors of part 11 applied only to the data that directly affects product quality and safety, and record (of the product) integrity.
For those records that are to remain the subject of 21 CFR Part 11. we will apply discretion in the validation of audit trails, record retention, and record
from FDA document)
This would appear to mean that if your in-house document control is secure and robust; then it will be acceptable in the matter of audit trail / record retention and record copying.
We will enforce all predicate rule requirements, including predicate rule record
and recordkeeping requirements. (extract
from FDA document)
This is a statement to the effect that in all other ways 21 CFR Part 11 will be enforced.
Accordingly, we recommend that, for each record required to be maintained under predicate rules, you determine in advance whether you plan to rely on the electronic record or paper record to perform regulated activities. We recommend that you document this decision (e.g., in a Standard Operating Procedure SOP), or specification document). (Extract from FDA document )
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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.
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.
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.
This document follows Validation Online's standard method of using a fully detailed and interactive generic document and enabling to use the attached SOP to quickly convert this generic document 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.
This computer validation is suitable for all major validation projects and contains the underlisted interactive documents.VMP, VP, URS, VRA, DQ, IQ, OQ and PQ.
Package Computer Validation Level-2. (Issue 3) -- $610.00
The complete chain of regulatory required documentation for the validation of a computer system minus the VMP. This Validation Package contains one of each of these documents:VP, URS, DQ, VRA, IQ, OQ, PQ.
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.
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.
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.
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.
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
devidences (within permitted tolerances) that exist are random and not a
trend that will lead to out of specification operation during