How Do I Shave Weeks or Months from My Software Validation?

software validationThe answer to this question is simple: have someone else do the work for you. Since there are two times (reasons) that validation is required there should be two approaches to making validation less onerous.

Software Validation Reason #1

The first reason that validation is required is unavoidable, e.g. moving to new software. But since validation is a significant effort associated with implementing any new system in a FDA regulated life sciences company, there has to be a better way than creating test scripts yourself.

Through the use of strict development methodologies such as GAMP5 with its risk-based validation approach and appropriate documentation, it is possible for a life sciences labeling vendor to pass vendor audits with excellent results. These audits, which include the review of software validation that is performed in-house is work that you will then be able to leverage to your advantage. Thus, your life sciences labeling software vendor should welcome regular customer inspections. When a company has served life sciences giants for over two decades, regular validation of their own product becomes part of their DNA.

The outcome of regularly scheduled audits should be a comprehensive validation documentation packet including: URS/FRS, functionality matrix, installation qualification (IQ), operational qualification (OQ), protocols, test cases, and test scripts for every function of the software system.

This exercise also needs to be performed whenever significant changes to the functionality of the software are introduced. Consequently, system users who have access to vendor supplied unexecuted test scripts will not have to create a validation plan from scratch. This can save hundreds of staff hours and accelerate implementation and go-live dramatically.

Moreover, the validation packet should be written by long-term veterans of the Life Sciences industry and should be successfully executed at multiple pharmaceutical, biopharma and medical device manufacturing facilities. This will ensure that the work is applicable within your company. Your life sciences labeling company should have a customer base that has been 100% successful with having their auditors accept this form of validation.

The activity and outcome that is described above should be available in two formats. The first is fully-executed test scripts in PDF form and the latter being test scripts which can be modified for your environment.

Software Validation Reason #2

I stated that the first reason why software validation is required is that the software is new to your organization and its unique environment. I went on to explain that you can make your validation less challenging by using the internal validation work of your vendor. The other reason why software validation is required is that the software has changed or the business process has changed.

While the latter is often necessary and therefore the validation is difficult to avoid, the former can be eliminated with smart software design. If part of the functionality of the software is its ability to allow user modification such as adding new fields of information for tracking (change by configuration), this functionality can be validated by the vendor. In this way, the user can make changes through configuration yet does not need to revalidate the software since the ability to make changes at the end-user level has already been validated.

Validation is considered a necessary but laborious task and the mere thought of it keeps many life sciences companies from realizing the benefits of new, good changes. It does not need to be this painful! Given the right approach, whether it may be vendor-driven validation efforts and material evidence or software that is designed in such a way that it minimizes or eliminates the need for revalidation, organizations can move on to realize the benefits of new approaches and technologies without the burdensome costs that are usually associated with them.

Enterprise Labeling Efficiencies Realized

Enterprise labeling is a term that refers to a labeling management solution which can include label design, review, and controlled revision with printing capabilities across multiple global locations. An enterprise labeling system that is designed for the life sciences must accomplish all of the above but in addition, it must comply with the provisions of 21 CFR. A Life Sciences specific enterprise labeling solution utilizes software technology that retains label data and imposes appropriate and auditable controls for compliance with government regulations to all labeling. It makes the processes of review and revision easier than ever before and reduces the risk of product recalls or other labeling related problems.

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What Do Software Validation Services Entail?

During the course of software engineering, testing and software project management, validation refers to the process of verifying that a software solution meets required specifications. This is a formalized process and is required within the life sciences. Software validation will ensure that your software solutions comply with requirements. Failing to do so can result in your company being issued a 483. If a computer system is used to provide information to a regulatory body (such as under FDA 21 CFR Part 11), or meet requirements for the regulatory body, the system must be validated. Continue reading

What Is An MES System?

A manufacturing execution system (MES) involves a computerized system that is used in manufacturing plants to indicate conditions on the plant floor and ways in which the conditions may be optimized to increase efficiency and production. Because an MES is a large, complex and varied application, there is no standard approach to implementing a MES system. Every system must be designed and customized to provide a specific solution to suit a company’s individual needs. Continue reading