As the pharmaceutical industry navigates the challenges posed by the ongoing pandemic, the need for innovative solutions in compliance auditing has become increasingly apparent. Singota Solutions, a leading CDMO based in Bloomington, Indiana, has risen to the occasion by pioneering a remote audit process amidst travel restrictions and evolving safety protocols. Leveraging cutting-edge technology and a commitment to transparency, Singota has successfully conducted virtual client audits, ensuring robust compliance while safeguarding employee and client well-being. This article explores Singota’s journey in adapting to the new normal, from the utilization of small batch aseptic fillers to implementing aseptic manufacturing solutions. Delve into their approach to cold chain pharmaceutical storage in a GMP compliant warehouse and the intricacies of injectable formulation development, all while embracing the power of remote auditing to maintain operational continuity and foster client trust in unprecedented times.
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The effects of the pandemic have been far reaching within the pharmaceutical industry and compliance audits have not been immune. Widespread travel restrictions and adjusted visitor policies have prevented standard onsite internal audit processes from occurring. As a CDMO, Singota Solutions (Bloomington, Indiana) has excelled at providing clients with transparent and robust compliance audits. This has historically been achieved through onsite visits and face-to-face interactions. Due to current events, Singota has been required to adapt quickly to the changing environment to maintain a high level of service while protecting employee and client safety.
Immediately following news of the pandemic in March 2020, Singota implemented various changes to acclimate to the new norm. One of these changes included the creation of a remote audit process, which encompassed new approaches to document review, facility tours, and subject matter expert (SME) interviews. In April 2020, Singota executed its first successful virtual client audit. The audit in question was performed for a prospective client who had not previously worked with Singota. Not only was there an obstacle to implement a new and untested process, but there was also a challenge to build rapport and trust with a new client. Through use of the new process, Singota was able to meet client expectations and requirements efficiently and effectively, as well as establish a fruitful relationship.
Through subsequent virtual client audits, it was conveyed to Singota that we were ahead of the game in terms of remote auditing and have “exceeded expectations.” Although success was achieved through the new remote audit approach, Singota sought to improve to make the process more robust. One of the more significant improvements made was the implementation of the live facility tour approach. Previously, company videos and photographs of the facility were used in lieu of the standard tour. Although this served to provide clients with more familiarity with the company, it was recognized that the interactive experience that comes with an onsite facility tour was lost. During the live facility tour, clients can experience the facility as if they were onsite. Tour hosts can adjust the tour content to accommodate specific client requests and provide clients with a more interactive experience. The live virtual tour also ensures that clients can view their materials and processes real time and can have confidence that Singota is handling their materials with attention and care. Additionally, the live tour approach enables Singota to connect with clients on a more personal level, as the confines of simple phone calls are abandoned for virtual “face-to-face” interactions via camera sharing.
Reliance on technological resources continues to play a pivotal role in our society. Perhaps now more than ever before, critical infrastructure industries rely heavily on robust hardware and secure software systems to minimize disruptions and maintain critical facets of business continuity. Working within a highly regulated industry presents unique challenges to the adoption of leading-edge systems and software, often creating the potential for pharmaceutical companies to lag in technological advancement. The onset of COVID-19 certainly highlighted the criticality of maintaining robust computer systems and software. Singota’s unwavering commitment to being accountable, agile, and transparent has never been more apparent. By continuing our focus on improvement initiatives, including routine assessments of leading-edge technologies, Singota was able to implement a somewhat swift transition into the term now affectionately referred to as “remote auditing.”
Facilitating an effective remote audit proved to be a unique challenge. As noted earlier, Singota has an obligation to provide our clients with transparent and robust compliance audits, all while maintaining our commitment to client confidentiality. In order to effectively meet this charge, Singota has employed a unique combination of software systems and processes to enable our clients the ability to perform robust quality audits safely, efficiently, and effectively. Since the necessity for working from home and not accepting visitors began in March 2020, Singota has successfully completed 17 remote audits utilizing this approach.
To facilitate the audits, Singota utilizes video conferencing software by Zoom Video Communications, Inc. Zoom is utilized to facilitate the opening meeting, subject matter expert discussions, as well as closing meeting activities. In the interest of maintaining client confidentiality and data privacy, Zoom communications are established using 256-bit TLS encryption and all shared content is encrypted using EAS-256 encryption. Singota also utilizes in-app features to promote content confidentiality throughout the course of the meeting.
Document viewing and sharing is a critical aspect of the auditing process. Provided that clients are unable to review documentation utilizing the conventional format, it was important for Singota to establish a process to enable timely, secure sharing of documentation for review. Singota has implemented Citrix’s document and file sharing service, known as ShareFile. Citrix ShareFile is a secure, cloud-based Software-as-a-Service (SaaS) solution that enables business-class file sharing and document collaboration activities. The SaaS application is hosted within cloud service providers that are SOC 1/SOC 2/ISO 27001 audited and certified. Stored files are secured utilizing AES 256-bit encryption in addition to unique per-file keys. User-accounts are created and configured to allow client auditors to review requested documentation efficiently and on-demand. One particular area of focus for Singota has been pre-audit document submission. Utilizing the audit agenda and the Singota SOP catalogue, clients can make document requests in advance of the audit. This approach enables our clients to concentrate their efforts on process review and subject matter expert discussions during the audit.
The COVID-19 pandemic has compelled countless companies to reassess processes once deemed to be in a solid state. Through embracing new processes and re-purposing certain aspects of technologies, Singota has been able to minimize disruptions to critical drug development and manufacturing timelines. Moving forward, Singota will continue to maintain its commitment to the Mission Statement, “delivering quality customized service to each client, dedicated to doing things right the first time by being accountable, agile, and transparent.”
