How Does E-WorkBook Measure Up to the FDA’s Updated Data Integrity Guidance?

The importance of data integrity

The research and development (R&D) industry has a responsibility to ensure the drugs they produce are safe, effective and high quality, and data integrity is key to making that happen.

But it’s not always smooth sailing. Upon inspecting current good manufacturing practices (cGMP) in labs in the last few years, the FDA found multiple violations around data integrity. And these have increased in number compared to previous years.

As is the sequence of things (and their responsibility to do so), the FDA acted appropriately. They issued warning letters, import alerts, and consent decrees. In 2018 alone, the FDA issued 85 warning letters, of which 42 were data integrity related. Violations most cited were those referencing ‘Laboratory Records’ and ‘Review of all Data’.

And in late 2018, they reviewed their guidance on data integrity, making any necessary updates to the document. While these are just guidelines, they are something to aspire to – the next level of data integrity in the lab. Let’s take a closer look at a few of these and how the IDBS E-WorkBook can help bring you closer to your data integrity target (or rather, the FDA’s).

Electronic data management is the way forward

E-WorkBook is an electronic data management platform, which enables you to improve data integrity in the lab. It captures all metadata relevant to the experiment and can easily be configured for GMP practices. All activity is logged, with time stamps and records of each and every amendment by personnel.

Everything is electronic, and scientists at the bench operate on a single platform. No need to flit between Excel spreadsheets and a paper notebook – all the information needed is in a single location, accessible at the press of a button.

Making reporting easier than ever

‘When generated to satisfy a cGMP requirement, all data become a cGMP record. You must document, or save, the data at the time of performance to create a record in compliance with cGMP requirements.’

In an average lab setting, there are multiple different systems and instruments, all generating reams of data per experiment. If these don’t communicate, the data could end up in silos – incomplete and even inaccurate.

Also, missing information warrants an investigation to get the to the bottom of the issue, which takes time out of a scientist’s day and delays other projects in the pipeline.

E-WorkBook captures data from instruments such as pH meters and balances. Data is captured and recorded electronically, removing the need for manual transcription and intervention, and drastically reducing the chance of accidental errors introduced as a result.

Getting to the bottom of an issue

‘FDA encourages you to demonstrate that you have effectively remediated your problems by investigating to determine the problem’s scope and root causes, conducting a scientifically sound risk assessment of its potential effects.’

Here, E-WorkBook creates links between objects and tracks them throughout their journey, from origin to the end product. If there’s an issue with a batch, experiment or sample, you can easily retrace their footsteps to find the root cause.

This level of traceability also enables simple and effortless review for auditing purposes.

Invalidating results and excluding them

When it comes to invalidating a cGMP results and leaving it out from decisions of batch conformance, the FDA is clear this is not the ideal situation.

‘Data created as part of a cGMP record must be evaluated by the quality unit as part of release criteria and maintained for cGMP purposes. Electronic data generated to fulfill cGMP requirements include relevant metadata required to reconstruct the cGMP activity capture in the record.’

As a scientist, if you must exclude results, you need valid, documented, and good scientific justification. And even then, all the data must be in the report, including the original invalidated data.

On top of that, you must add the investigation report that justifies why you took out the excluded data. These guidelines are the same for each format, whether you’re using a paper lab notebook or an electronic one.

With E-WorkBook, you can drop different file types into one place, and have your original results sitting alongside your investigational report. This make for easy and clear viewing and adds context to experiments.

So, not only is it easy to collate the results – including the invalidated ones – but activated built-in GMP protocols reinforce the fact.

Preventing unauthorized changes

‘When login credentials are shared, a unique individual cannot be identified through the login and the system would not conform to the cGMP requirements…The FDA requires the system controls, including documentation controls, be designed in accordance with cGMP to assure product quality’,

and

‘You must exercise appropriate controls to assure that changes to computerized MPCRs or other cGMP records or input of laboratory data into computerized records can be made only by authorized personnel.’

With E-WorkBook, each user has their own unique ID for a secure login. While you can access your experiments remotely – from your office, lab or favorite café – each sign-on requires a password unique to you. That way, it is easier to create accurate and full records of personnel activity – what has been done, by who, when and how.

When it comes to securing computer systems, adding a layer of permissions is recommended. E-WorkBook provides the option to add a layer of permissions to your files and experiments, restricting access to authorized personnel.

Further to that, when the report is complete, it is locked to prevent further edits. Only those with specific authorization can then unlock the experiment.

In addition, all activity is logged and recorded for reporting purposes, as well as for quality and inspection reasons. This level of traceability enables you to see all relating events when you need to, creating an audit trail for regulatory inspection.

Setting appropriate controls for traceability

‘Electronic signatures with the appropriate controls can be used instead of handwritten signatures or initials in any cGMP required record. Firms using electronic signatures should document the controls used to ensure that they are able to identify the specific person who signed the records electronically.’

Another feature that fosters data integrity is the sign-off function. After each experiment created in E-WorkBook, the author must be sign off on the work and request a colleague to review it electronically, preferably not through the black hole that is an email chain.

Once the report and the associated files have been reviewed, they are signed off with an electronic signature and a time stamp – which cannot be amended. In fact, scientists can lock their experiment to prevent further changes, maintaining its integrity.

 

With these systems and checks in place, E-WorkBook could help you improve data integrity in your lab – giving your work a regulatory boost and approved faster.

 

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