In the life sciences industry, many companies have a heightened sensitivity to risk due to increased regulatory scrutiny and/or product quality issues. As a result, the concern around compliance has renewed many organizations’ focus on audit programs, which are being re-calibrated as a tool to identify the most vulnerable parts of the business.
Enterprise quality and compliance management software solutions can provide the necessary consistent mechanism to conduct audits. Imagine this for a moment: A company defines an unlimited number of draft audit agendas that can be modified for each audit (or not) based on business needs and auditor permissions. In turn, audits are conducted within a consistent framework, providing more reliable audit data to management teams so that they can effectively gauge trends in the company and focus on areas of risk.
Beyond the ability to leverage more accountable data from audits, however, many professionals at the medical device and pharma companies I speak with also talk about a company-wide need for consistency within audit programs. This is in part because audits and quality management have traditionally been human-based processes and are therefore prone to variation, which can result in costly errors. A number of executives I’ve talked to also stress the need for a more efficient means of performing audit-related tasks.
For businesses that have already migrated to dedicated electronic systems for managing quality and compliance processes, the benefits are already apparent. Yet auditors, who play an equally important role in the overall process, often find those same electronic systems aren’t built for them.
Ideally, auditors should be able to conduct audits within a consistent framework while tailoring their approach based on what they see in real time, again based on business rules and permissions. The right kind of tools empower auditors to utilize their skills and experiences to obtain the highest business benefit possible, instead of simply following an audit ‘checklist’. And with the advanced software available today, instead of producing reports on rudimentary text editing applications, auditors can access relevant information offline and author findings in real-time without an internet connection, saving hours during the transcription process when completing a final report.
Advances in technology can also improve supplier collaboration. One of the most consistent challenges companies face is managing supplier responses to observations. Even when companies receive the response on time, oftentimes it is missing a key element and must be sent back for rework. That is why EQMS should have the functionality to export observations from the system of record and email them to suppliers — so they can fill out the information required for your quality system. This same technology can be used to distribute questionnaires to suppliers, thereby managing a proactive aspect of supply chain management and utilizing that data to help prioritize which suppliers warrant on-site audits. As manufacturers and suppliers begin to evaluate and respond to data with the goal of determining the best way to prioritize resources based on enterprise risk, the need for such remote oversight will increase over time.
Although on-site and supplier audits may never be easy, the technology is here to reduce the burden for everyone involved. What is your company doing today?
Tim Mohn is an industry principal in Sparta Systems’ product management group. Check him out at Tim.Mohn@spartasystems.com.