BY SIEGFRIED SCHMITT, VP, REGULATORY COMPLIANCE CONSULTING, PAREXEL
A chartered chemist and an accomplished author and editor of several industry publications. He has many years helping customers with all aspects of quality and compliance systems, processes, facilities, and operations for drug substances and drug products.
Just because the COVID pandemic disrupted business operations, the importance of data integrity has not diminished. Accurate data is the foundation of product quality. And while the subject became somewhat less prominent for regulators, who made it clear that they understand the industry’s current challenges, it hasn’t gone away. How can sponsors reconcile the adaptations they made during the emergency with data quality assurance and regulatory expectations for compliance?
First, let’s take a look at some of those adaptations – and the unforeseen consequences impacting the integrity of data.
Disruptions to the Business Model
Data integrity relies on people, processes, systems, and procedures. Only if these all work together can data integrity be assured. The common business model relied on face-to-face team interactions and access to company systems and assets, predominantly from an office or factory location. Processes and procedures were designed in alignment with this operations model. The pandemic resulted in abandoning long-established ways of working on several levels.
Breakdowns in Approval Workflow
Every site, facility, or operation was affected by the need to have at least some staff members working from home. This meant much heavier reliance on automated systems. However, many processes and procedures are not amenable to remote work. For example, review and approval of quality and technical agreements with suppliers, since most companies designed their workflows relying on handwritten signatures.
Here’s what happened in one instance. When the offices were closed, the first line of defense was to turn to automated workflow solutions with compliant electronic signatures. Those solutions were readily available. However, validating the software and training staff proved to be difficult and time-consuming. Meanwhile, the company had to rely on postal mail for months before the electronic solution could be released. The process required one person to print the 50-odd-page document, sign and then mail it to the next person for signature.
Inevitably, errors were found in the document during this lengthy and cumbersome approval process. Instead of starting from the beginning, the errors were corrected in the electronic document, and then revised pages were printed and replaced in the already partially signed document. The flaw here? The first person signed one document, while the last person signed a different version.
Of course, the company retained the electronic document versions, which then proved to be in violation of data integrity principles. To top it off, nobody had taken the time to update the procedure that would describe the process involving postal mail.
As another example, restrictions meant that quality assurance personnel could not walk the shop floor as they normally would, conduct on-site supplier audits, or perform other oversight activities in person and on-site. This led to the disposal of an entire batch in one company, resulting in yet another supply chain shortage.
Staff members were adding the raw materials to a fermentation vessel, calculating several amounts depending on the batch size. One personnel forgot to enter the calculated value to the batch record, then conveyed the incorrect value to the operator. The operator added that amount to the reaction solution and then failed to enter the value in the batch record (it remained an empty field). When the batch was analyzed at the end of the fermentation process, it failed its specifications.
A review of the batch record by QA found the missing entry weeks after the batch was completed, which led to the unraveling of the story. Under normal circumstances, QA would have found the missing entry and, if not saving the whole batch, would have reduced the delay, unnecessary rework, and associated costs.
Lost Data Due to Delayed Maintenance
Most companies were forced to curtail or postpone maintenance activities, sometimes by months and even years, leading to deviations from the quality system. In one situation, several laboratory instruments had not been networked. During the pandemic, only essential staff were permitted into the laboratory. The standard operating procedure required an IT technician to take monthly backups of the data on the stand-alone systems, which was suspended because IT support staff were not considered essential.
Unbeknownst to the laboratory staff, these stand-alone instruments had limited storage space. Instead of alerting the users that the memory was full, the systems started to overwrite old data. By the time this was detected, the laboratory had lost several months’ worth of data, affecting several clinical trials.
How to avoid data integrity pitfalls
As shown in the examples above, these issues directly affect data integrity and impact one or more of the ALCOA+ requirements.
What can you do to avoid these kinds of calamities?
1. Ignore it? Not an option.
2. Issue a disclaimer or say “Sorry”? Not acceptable.
3. Investigate and address all issues? The correct approach.
At Parexel, we have been working throughout the pandemic with customers, developing effective and efficient strategies for the assessments, supporting customer teams with the investigations, and developing remediation plans and activities. We can fully assess all deviations from established processes and their impact on data integrity. We can help prepare a project plan, perform the investigation, and report and address deviations identified.
Never Stop Bioteching
Keeping pace with the current environment requires anticipating and adapting to challenges before they happen. Parexel Biotech provides the experience and guidance you need to help you reach your goals every step of the way. Visit our website to learn more about our compliance capabilities or connect with one of our experts for further insights. #NeverStopBioteching