Enterprise Information Management can help to streamline audits in the Life Sciences firms

Audit Management has a deep and famed history. The word “audit” originates from the Latin word “auditus” which means “to hear.” Audits, which began in the early 15th century, conveyed in a recognizable manner today. Auditing was defined as the official examination of accounts and was conducted verbally due to limited education rate. One can easily imagine a tonsured monk, bent over his book of accounts, sweating and stressed while addressing his calculations to the superior. Paradoxically, what 15th-century audits lacked in paperwork traces, databases, SOPs(Standard Operating Procedures) and CAPA(Corrective Action Prevention Action).

Audits are now everywhere across all types of businesses and industries. In fact, audits are rising in frequency, due to the increasing tide of regulations and compliance, especially in life sciences firms. Still, regulatory compliance isn’t the only reason why life sciences organizations should invest resources into audits, the results of best audit management can significantly influence an organizations ability to deliver a quality product or service.

Audit Management: Walk Through the Process

Overall, two human-centered processes make up what businesses define as “audit management.” These are “being audited” and “auditing.” This difference is important because highly regulated divisions engage in both internal and external audits. “Auditing” involves document search, develop reporting and regulate responses. “Being Audited” is the provision to the auditor(s) of demanded assets and documentation as well as the administration of the investigation and the analysis of issues including consecutive improvement activities. Both methods require the parties connected to actually conduct interviews, capture data, run reports and share findings.

There’s a flow to audits; the summary generally plays out thusly:

  • The auditor visits the premises, or in the case of an internal audit, the audit is initiated.
  • The auditor interviews staff studies SOPs and demands evidence that they are being compiled.
  • The company provides documents, process verifications and proof of actions.
  • The auditor concludes the “gap”— primarily the activities that the organization actually conducts verses the activities documented in their SOPs and other quality guidelines and methods.
  • The company is provided with an audit report. Then they must take corrective action—which must be documented.

The companies are not being subjected to a recitation of activities—auditees are overwhelmed with a great deal of work to provide the auditor with the data they require. Data and documents are often distributed in multiple systems, emails, formats, and reports across the company. The auditor is also imposed with sifting through and analyzing a great deal of documentation. As you can assume, chaos often happens, and the result is an upsetting audit. This scenario often occurs from an organization’s lack of a formalized information management strategy and policy for audit management related data and processes.

The Comprehensive Leap Forward: Enterprise Information Management

Audits are proving to be a key to organizational success. If one view audits as a management tool to be applied to verify real evidence of process, effectiveness, and achievement, it is clear that, firstly, they are essential and secondly they are worthy of investment.

More organizations are spending on technology to sustain this endeavor. In fact, it’s arguable that the prominent change in auditing over the centuries has been the confluence of technology and the auditing process. Many companies, especially in life sciences have significantly analyzed and developed their auditing processes by executing enterprise information management (EIM). Operatively applying an EIM system can take life science companies from an unmanaged place of folders, documents, and emails to a controlled atmosphere to manage content, processes, tasks, and workflows so that they can be traced and verified by auditors.



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