• Home
  • Advancing the use of Remote Audits in the Life Science Industry

Advancing the use of Remote Audits in the Life Science Industry

The Covid-19 pandemic has propelled the interest in an old topic, remote audits. The technology needed to perform a remote audit already exists, making this an attractive alternative to the long commutes required for an onsite audit. Although some certification bodies remain resilient to this idea, the Covid-19 pandemic reinforced the need for change in the way we conduct audits, embracing technological innovations and the need for flexibility in a changing workplace.

We will discuss the benefits of remote audits and the obstacles for their implementation. We will also look at how digital tools such as an eQMS (Electronic Quality Management System) can make these remote audits successful.

What are remote audits?

Companies operating in regulated industries must undergo periodical audits by independent bodies or regulatory authorities. These audits are usually performed through physical visits to the audited companies, reviewing documents, and possibly research and manufacturing facilities. With changes in technology, it is now possible to perform remote audits, also known has e-audits, in which information is presented to auditors through forms such as live streaming and electronic documentation software.

Benefits and difficulties of performing remote audits

Benefits

A substantial amount of time is saved with a reduced, or even eliminated, need for commuting. This is even more substantial when considering companies that operate in remote regions, using foreign auditors, at a high cost.

The logistics of aggregating the required people for an effective audit is simplified by eliminating the need for physical meetings. People participating in the audit process can do so independently of their current location.

Difficulties

Many companies store their documents in paper binders, and some have scanned copies of documents in file folders. This makes it harder for the auditor to access the documents in a controlled way – especially if the company

Trust is the main issue with conducting a remote audit, especially when audits involve research and manufacturing facilities. Physical access allows for a more thorough search for physical evidence that is crucial for identifying critical issues.

Some certification and accreditation bodies do not approve audits performed remotely. Besides the issues mentioned previously, there is a lack of decision on which parts of the audit process can and cannot be performed remotely.

EQMs and Remote Auditing

Audits involve an extensive review of a company’s information, a massive hurdle for the success of a remote audit, which is conducted using electronic tools. The adoption of an Electronic Quality Management System allows companies to digitize their quality management procedures. An electronic system allows for easy access, decreasing the time needed to find a document, being accessed remotely by an auditor.

Without the use of an eQMS, the cost and difficulty of performing a remote audit significantly increase. Instead of one system, many systems may become needed, such as email, Google Drive, DropBox, eSignatures, etc., creating organizational difficulties and usually involving the scanning of paper documents, which may compromise readability. Also, security and confidentiality are significant issues that conventional software has problems addressing. An eQMS enables the sharing of documents in a way that doesn’t compromise sensitive information, by disabling printing, placing “confidential” watermarks, giving time-limited access to records, etc.

SimplerQMS and Auditing

SimplerQMS understands the complexities surrounding audits, especially a remote one. Our system is designed to be time productive, allowing quick access to the required files and their sharing.

A reliable electronic system is vital for a successful audit, especially when FDA 21 CFR Part 11 compliance is needed.  Full compliance with 21 CFR Part 11 is provided to all our customers at no extra cost. We understand how important our system is for a successful audit, which is why we cooperate with our customers and auditors during the auditing process.

SimplerQMS has, through its years of expertise, understanding what is needed for a successful audit. We have the required documentation regarding the validation of our eQMS and the knowledge to talk to auditors directly about any issue regarding it. This can be done during a remote meeting.

We are ISO 13485:2016 certified and cover ISO 9001:2015, proving that our electronic system is validated and compliant with the most recent regulation. Remote auditing can be challenging, but with a trusted partner, who knows the needs and processes of the life science industry, it can become a genuine opportunity for your company to save time and money with SimplerQMS.

Leave a Reply

SimplerQMS - Telephone +45 9390 1614 - Email: info@simplerqms.com