How to Overcome the Subjectivity of Objective Evidence


Leveraging the power of a Validation Lifecycle Management System (VLMS)


According to FDA 820.3(z) “Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.” Ironically, the actual provision of objective evidence is subjective. Before we continue let’s call to mind the difference between subjective versus objective. A subjective perspective is influenced by emotion, or opinion. Conversely, an objective perspective is factual, measurable, and something you can quantify. When it comes to providing objective evidence to support a validation activity is, in fact, valid, we are influenced by opinion – expert opinion if you please — as to what objective is required. You don’t really know if your objective evidence is sufficient until it is scrutinized during an audit or inspection. Then the auditor or inspector’s professional opinion is subjectively exercised to assess your objective evidence.

As you can see from above we face a difficult situation. How do we deliver objective evidence with a high degree of certainty that it will withstand regulatory scrutiny? Appling a scientific method that is risk-based, consistent, and reliable is one way, possibly the only way. But how do we deliver upon these if we’re depending upon manual, paper-based processes that are difficult to manage and maintain? The answer here can be found by leveraging the power of technology that Validation Lifecycle Management Systems (VLMS) provide.

A VLMS replaces paper-based, manual processes with paperless electronic records, electronic signatures, and the ability to enforce compliance through programmatic controls. In other words, a computer system can enforce rules.

With a VLMS users are authenticated to ensure only qualified individuals are performing tasks. Functionality allows business rules that ensure compliance are enforced; otherwise users are unable to proceed or tasks processed through to completion. A VLMS can also consistently apply risk-based processes. For example, high risk requirements can trigger actions to require more objective evidence such as step-by-step electronic signatures, screen shots, or supporting file attachments at the test step level. This can be captured and maintained precisely where the requirement exists in the form of a hyperlink, that when clicked will immediately reveal the supporting objective evidence.

Now the best for last. If you’ve manually captured screen shots and assembled them in paper documents – the archaic way of performing validation – then you know how tedious this can be; also, it’s more error prone. With a VLMS objective evidence in the form of screenshots and file attachments can be captured and documented automatically.

In summary, a VLMS can be configured, based upon customer specific requirements, to consistently enforce an organization’s own risk-based methodology. When authorized users perform validation, they must follow the rules otherwise they cannot continue. Automation allows for objective evidence to be captured and documented at the push of a button. Also, automated trace matrices illustrate test coverage along with success and failures. Finally, any failures will be required to be addresses, successfully, through to completion.