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Showing posts with label Validation principles for software for pharma and medical devices manufacturing. Show all posts
Showing posts with label Validation principles for software for pharma and medical devices manufacturing. Show all posts

Thursday, June 16, 2011

Pharma Software Validation Pharma medical devices manufacturing

Pharma Software validation principles for the validation of software for pharmaceutical and medical device manufacturing.

A documented software requirements specification provides a baseline for both validation and verification. The software validation process cannot be completed without an established software
requirements specification (Ref: 21 CFR 820.3(z) and (aa) and 820.30(f) and (g)).

Software quality assurance needs to focus on preventing the introduction of defects into the software development process and not on trying to “test quality into” the software code after it is written.
Software testing is very limited in its ability to surface all latent defects in software code. For example,the complexity of most software prevents it from being exhaustively tested. Software testing is a necessary activity. However, in most cases software testing by itself is not sufficient to establish confidence that the software is fit for its intended use. In order to establish that confidence, software developers should use a mixture of methods and techniques to prevent software errors and to detect software errors that do occur. The “best mix” of methods depends on many factors including the development environment, application, size of project, language, and risk. Requirements of software validation in pharma

To build a case that the software is validated requires time and effort. Preparation for software validation should begin early, i.e., during design and development planning and design input. The final
conclusion that the software is validated should be based on evidence collected from planned efforts conducted throughout the software lifecycle.

Software validation takes place within the environment of an established software life cycle. The software life cycle contains software engineering tasks and documentation necessary to support the
software validation effort. In addition, the software life cycle contains specific verification and validation tasks that are appropriate for the intended use of the software. This guidance does not recommend any
particular life cycle models – only that they should be selected and used for a software development project.

The software validation process is defined and controlled through the use of a plan. The software validation plan defines “what” is to be accomplished through the software validation effort. Software
validation plans are a significant quality system tool. Software validation plans specify areas such as scope, approach, resources, schedules and the types and extent of activities, tasks, and work items.

The software validation process is executed through the use of procedures. These procedures establish “how” to conduct the software validation effort. The procedures should identify the specific actions or
sequence of actions that must be taken to complete individual validation activities, tasks, and work items.

Due to the complexity of software, a seemingly small local change may have a significant global system impact. When any change (even a small change) is made to the software, the validation status of the
software needs to be re-established. Whenever software is changed, a validation analysis should be conducted not just for validation of the individual change, but also to determine the extent
and impact of that change on the entire software system. Based on this analysis, the software developer should then conduct an appropriate level of software regression testing to show that
unchanged but vulnerable portions of the system have not been adversely affected. Design controls and appropriate regression testing provide the confidence that the software is validated after a software

Validation coverage should be based on the software’s complexity and safety risk – not on firm size or resource constraints. The selection of validation activities, tasks, and work items should be
commensurate with the complexity of the software design and the risk associated with the use of the software for the specified intended use. For lower risk devices, only baseline validation activities may
be conducted. As the risk increases additional validation activities should be added to cover the additional risk. Validation documentation should be sufficient to demonstrate that all software validation
plans and procedures have been completed successfully.

Validation activities should be conducted using the basic quality assurance precept of “independence of review.” Self-validation is extremely difficult. When possible, an independent evaluation is always
better, especially for higher risk applications. Some firms contract out for a third-party independent verification and validation, but this solution may not always be feasible. Another approach is to assign
internal staff members that are not involved in a particular design or its implementation, but who have sufficient knowledge to evaluate the project and conduct the verification and validation activities. Smaller
firms may need to be creative in how tasks are organized and assigned in order to maintain internal independence of review.

Specific implementation of these software validation principles may be quite different from one application to another. The device manufacturer has flexibility in choosing how to apply these validation
principles, but retains ultimate responsibility for demonstrating that the software has been validated.Software is designed, developed, validated, and regulated in a wide spectrum of environments, and for a wide variety of devices with varying levels of risk. FDA regulated medical device applications include software that:
· Is a component, part, or accessory of a medical device;
· Is itself a medical device; or
· Is used in manufacturing, design and development, or other parts of the quality system.

In each environment, software components from many sources may be used to create the application (e.g., in-house developed software, off-the-shelf software, contract software, shareware). In addition,
software components come in many different forms (e.g., application software, operating systems, compilers, debuggers, configuration management tools, and many more). The validation of software in
these environments can be a complex undertaking; therefore, it is appropriate that all of these software validation principles be considered when designing the software validation process. The resultant
software validation process should be commensurate with the safety risk associated with the system,device, or process. Software validation activities and tasks may be dispersed, occurring at different locations and being conducted by different organizations. However, regardless of the distribution of tasks, contractual
relations, source of components, or the development environment, the device manufacturer or specification developer retains ultimate responsibility for ensuring that the software is validated.good manufacturing practices

Also see

Pharmaceutical validation

21 CFR Part 11 Requirements

Medical Device 510(k) Clearances

Software validation Regulatory Requirements

Benefits of software validation in medical devices and pharmaceuticals

Sunday, June 12, 2011

Pharma software validation medical devices pharmaceuticals

Medical devices and pharmaceutical software verification and validation benefits of software validation

Software validation is a critical tool used to assure the quality of device software and software
automated operations. Software validation can increase the usability and reliability of the device,
resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to device manufacturers. Software validation can also reduce long term costs by making it easier and less costly to reliably modify software and revalidate software changes. Software maintenance can represent a very large percentage of the total cost of software over its entire life cycle.
An established comprehensive software validation process helps to reduce the long-term cost of
software by reducing the cost of validation for each subsequent release of the software.

Software validation is a part of the design validation for a finished device, but is not separately defined in the Quality System regulation. In practice, software validation activities may occur both during, as well as at the end of the software development life cycle to ensure that all requirements have been fulfilled. Since software is usually part of a larger hardware system, the validation of software typically includes evidence that all software requirements have been implemented correctly and completely and are traceable to system requirements. A conclusion that software is validated is highly dependent upon comprehensive software testing, inspections, analyses, and other verification tasks performed at each stage of the software development life cycle. Testing of device software functionality in a simulated use environment, and user site testing are typically included as components of an overall design validation program for a software automated device.
Software verification and software validation are difficult because a developer cannot test forever, and it is hard to know how much evidence is enough. In large measure, software validation is a matter of developing a “level of confidence” that the device meets all requirements and user expectations for the software automated functions and features of the device. Measures such as defects found in specifications documents, estimates of defects remaining, testing coverage, and other techniques are all used to develop an acceptable level of confidence before shipping the product. The level of confidence, and therefore the level of software validation, verification, and testing effort needed, will vary depending upon the safety risk (hazard) posed by the automated functions of the device.

Software verification provides objective evidence that the design outputs of a particular phase of the software development life cycle meet all of the specified requirements for that phase. Software verification looks for consistency, completeness, and correctness of the software and its supporting documentation, as it is being developed, and provides support for a subsequent conclusion that software is validated. Software testing is one of many verification activities intended to confirm that software development output meets its input requirements. Other verification activities include various static and dynamic analyses, code and document inspections, walkthroughs, and other techniques. good manufacturing practices

Also see
21 CFR Part 11 Requirements

Medical Device 510(k) Clearances

Wednesday, June 8, 2011

Pharma Software validation Regulatory Requirements definition

Regulatory Requirements for Pharma software validation definition.

In pharmaceutical and medical device industry many manufacturing process depend on computer software( Also see 21 cfr part 11) in early times there were many cases found, where the medical deices were recalled just because of software malfunction,  later it was found that those faults were caused due to improper implementation of changes made in them, lack of change control impacted the production of faulty medical devices.

Therefore now software validation is a requirement of the Quality System regulation, which was published in the Federal Register on October 7, 1996 and took effect on June 1, 1997. (See Title 21 Code of Federal Regulations (CFR) Part 820, and 61 Federal Register (FR) 52602, respectively.) Validation requirements apply to software used as components in medical devices, to software that is itself a medical device, and to software used in production of the device or in implementation of the device manufacturer's quality system.

Software validation definition as a process which confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.”

Unless specifically exempted in a classification regulation, any medical device software product
developed after June 1, 1997, regardless of its device class, is subject to applicable design control
provisions. (See of 21 CFR §820.30.) This requirement includes the completion of current
development projects, all new development projects, and all changes made to existing medical device software. Specific requirements for validation of device software are found in 21 CFR §820.30(g). Other design controls, such as planning, input, verification, and reviews, are required for medical device software. (See 21 CFR §820.30.) The corresponding documented results from these activities can provide additional support for a conclusion that medical device software is validated.

Any software used to automate any part of the device production process or any part of the quality system must be validated for its intended use, as required by 21 CFR §820.70(i). This requirement applies to any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, complaint handling, or to automate any other aspect of the quality system.

In addition, computer systems used to create, modify, and maintain electronic records
and to manage electronic signatures are also subject to the validation requirements.
(See 21 CFR 11.10 (a).) Such computer systems must be validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.
Software for the above applications may be developed in-house or under contract. However, software is frequently purchased off-the-shelf for a particular intended use. All production and/or quality system software, even if purchased off-the-shelf, should have documented requirements that fully define its intended use, and information against which testing results and other evidence can be compared, to show that the software is validated for its intended use.
The use of off-the-shelf software in automated medical devices and in automated manufacturing and quality system operations is increasing. Off-the-shelf software may have many capabilities, only a few of which are needed by the device manufacturer. Device manufacturers are responsible for the adequacy of the software used in their devices, and used to produce devices. When device manufacturers purchase "off-the-shelf'' software, they must ensure that it will perform as intended in their chosen application. For off-the-shelf software used in manufacturing or in the quality assurance system.
Stay connected with us for software validation article series.

Also see
21 CFR Part 11 Requirements
Medical Device 510(k) Clearances

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