With a clear mandate to deliver value, drive efficiency at every opportunity and a dedication to continuously improve processes across the company, Bluefish Pharmaceuticals embarked upon an initiative to assess its methods of quality assurance and compliance management.

While the existing quality and compliance measures were sufficient, the company realised there was an opportunity to improve efficiency in both time spent and cost allocated. The current process relied upon a manual, paper-based approach, which proved to be admin-intensive and time-consuming. It required a dedicated, full-time member of staff to manually manage documents and the associated workflows. While the approach met industry standards, Berit Lindholm, chief executive officer at Bluefish Pharmaceuticals, wanted to explore opportunities to enhance the company’s efficiencies:

“The number of hours the team spent on ensuring we maintained our compliant status was quite intensive. With the goal to improve efficiency across all of our company procedures, I decided it best to explore solutions that were not only time-saving but cost-effective.”

After appropriate scrutiny and due diligence, Bluefish selected the pre-configured, SharePoint-based, enterprise EQMS, X-Docs by Formpipe utilising the Docs, Train and Forms modules. The latter consisted of preconfigured processes to manage Deviations, Change Controls and CAPAs. The EQMS met all of the company’s specified needs in relation to providing users with a platform to:

• Manage GxP-controlled documentation and maintain the necessary framework to satisfy auditors.
• Meet the rigorous audit demands for training records in support of employees performing regulated actions.
• Simplify the job of monitoring and reporting on the progress of activity including CAPA, change control, deviations and audits.

The contract with Formpipe was signed in May 2016. Describing the selection process, Berit comments:

“We reviewed many options, but X-Docs met our needs best. Formpipe’s values of professionalism, honesty, transparency and taking a collaborative and consultative approach to projects aligned nicely with our company and thus, made them a great choice as a trusted partner. It was clear from the demonstration, and positive customer referrals, that X-Docs would help us on our journey to continuously improve our quality processes and relieve some much-needed pressure on administration personnel.”

With quality assurance, and process management transformed, Bluefish has noted several benefits. Firstly, the firm has reduced manual administration by an estimated two-thirds. This represents a significant cost saving for the value-driven business. With X-Docs in place, Bluefish has full visibility over its entire quality-based workflow. The system assigns actions via push notifications and alerts, facilitating a sense of ownership and allowing vital tasks to be handled swiftly.

The automated reporting, sophisticated search functionality, and audit trail insights provide a level of transparency that surpasses the capabilities of previous methods. For processes like SOPs, Bluefish can now establish which members of staff are qualified to perform certain tasks, and which ones aren’t in a matter of seconds.