12 Questions To Ask Before Investing in Paperless validation

12 Sep 2018

Regulatory expectations related to GxP validation have increased in both inspection focus and in complexity. And, it doesn’t get any easier when your company expands, with the related validation deliverables, effort and compliance risks increasing further. The paper-based systems that rely on Microsoft Word, Microsoft Excel etc. are manual and labor intensive. They’re also susceptible to human error and potential non-compliance.

Wouldn’t it be good to make the process leaner? To reduce your schedules and risk – both to patients and your business?  The right e-validation solution can do just that, with better quality, more efficiency and the ability for all stakeholders to access relevant, up-to-date information in real time.  But what should you look for?


1. Will it offer real-time validation status and metrics?

An e-validation tool should allow you to query any system across your site or across all your sites. The dashboard should instantly give system status, such as Validated, Due for Review, In Review etc.

You’ll also want to see the status of all documents, exceptions etc. per system, project, site, organisation, etc. – at the push of a button.


2. Will it enable and maintain consistency?

You need a system that gives you a structured process that moves from one project to the next and across multiple sites. Of course, the system mustn’t be over-rigid and should allow for flexibility for site variations.


3. Will it streamline and automate the process?

Performing and managing the validation process end-to-end requires huge effort. You’ve got to author the design and test documents, get them approved, execute testing, post-approval, etc. You need a tool that can standardise, streamline and automate significant aspects of the process.


4. Will it be able to review and approve protocols?

The review and approval process can be very cumbersome, time-consuming and susceptible to error. Good document review and approval is a basic requirement and the greatest cycle time improvements will be achieved by a truly transparent and collaborative process where all parties can see and respond to each others comments online in real time and where there is no  disconnect such as checking out of the documents.


5. Does it have an electronic test-execution process?

This is the main ingredient for an end-to-end paperless e-validation system. If it can’t do this effectively, then it can’t remove paper, GDP errors  errors from your process.

The test-execution module should allow the tester to enter recorded results, create and manage any exceptions, upload any original evidence, apply his electronic signature, make changes post execution complete with audit trail and re-run scripts if necessary.


6. Does it auto-generate validation summary reports?

After your validation-testing, you must complete a system validation summary report. This discusses the testing you did, the results, the exceptions created and their resolution. In the paper-based/hybrid system, this stage is a paper and data chase that eats up time. The correct e-validation system should auto-generate all of this report.


7. Will it offer validation storage, search and retrieval?

It’s a must that you have a good system for storing and retrieving validation records. You’ll need to manage records centrally at source and have instant access from anywhere to support audit and ongoing operations.


8. Can it be scaled easily across multiple global sites?

Any enterprise software today that isn’t designed and developed for efficient global scalability is behind the curve. It’ll need significant rewriting and upgrading in the short to long term, putting a stop to any promised return as your business seeks to increases its usage.

There are many aspects to efficient scalability. These include being able to increase user numbers, add company sites and the content you can upload without affecting performance.

The tool must also make the business process scalable across your organisation. It should allow robust user management with permissions.  You’ll also want seamless sharing of the process and its templates from a centrally managed library.

The best tools are built on modern web-based stacks, and accessed securely on a browser where all the software is managed server-side.


9. Will it allow CFR Part 11/Annex 11 compliance?

Any system that creates, manages and retrieves electronic records must comply with FDA regulation 21 CFR Part 11 and Eudralex Annex 11.  Developing software that provides all the controls to meet these standards is not easy and many industry solutions have this built in as an after thought.  Only consider that solutions that are robust in this regard and where these controls are designed into the system from the ground up.


10. Can it provide a clear and justifiable business case?

Going electronic for complex business processes such as validation and GxP testing should make good business sense in terms of efficiency and compliance. While this is true, it may not always be so clear-cut and the system you choose will have a bearing on this.

Different systems will have different initial and ongoing pricing. They’ll need different levels of effort to deploy, extend, upgrade and support.

Adding an estimated payback period to your business case will help with the internal approval process. You can get a quick payback period estimate by calculating the initial total cost to buy and deploy the system (to Go Live). Then divide this by the estimated yearly savings (total savings less ongoing costs) that the tool will yield. This will give the number of years for the system to pay for itself.


11. Will it offer intangible benefits too?

A simple payback estimate reflects only the tangible, easy-to-quantify benefits. But a compliant, streamlined process will deliver many harder-to-quantify, intangible benefits, too.

These include making sales revenue sooner, more consistent quality (leading to faster product throughput), and less product rework. They also include less time to reach facility peak performance and, not least, fewer compliance and business risks.

These intangibles are very significant and often dwarf the tangibles, so you should consider them seriously.


12. What about vendor life science experience and quality?

Developing software for life sciences isn’t easy. It requires very significant investment in people with deep domain experience, quality processes and associated management.

The company you partner with becomes an extension of your business and it should understand the industry and the regulatory landscape. It should view quality in the same way you do.

This is a key question and any company selling into Life Sciences must put quality first. Ideally, they’ll have a formally certified QMS. In addition, they’ll design, develop, test and validate their solutions to Good Automated Manufacturing Practice (GAMP) or similar methodologies.



Not all market solutions are equal and, depending on your business needs, one technology may suit you over another. Selecting the correct solution for your business will have a very large impact on the resultant return for your company.

Initially identify WHY you want an e-validation system, then set the high-level business priorities (THE WHAT) that the solution must align with. Then proceed to finding the solution (THE HOW) that meets your immediate and potential future priorities.


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