TrakCel

While the existing quality and compliance measures were sufficient, TrakCel realised there was an opportunity to improve efficiency across the quality management systems.

Electronic quality management systems should be simple to use, adhere to current regulatory requirements and ensure quality systems data is visible and easily accessible. Formpipe’s X-Docs solution has been designed specifically for life science customers to meet these requirements.

X-Docs delivers efficiency that can be measured in working time saved and the intangible benefits of allowing the Quality Professional to focus on business improvements rather than administrative tasks.

For TrakCel, the decision to move to X-Docs has been business growth. This acted as a catalyst in initiating a business transformation project to become a paperless Quality Management System (QMS), strongly supported by their Chief Strategy Officer.

The implementation of X-Docs and X-forms took four months, from the point of initiating the project to the completion of the installed software validation activities and released for use.

Keen to implement a more robust way of managing quality assurance and demonstrating their compliant status, TrakCel researched the market to find a new solution. They needed a system which would not only be effective but facilitate a quick implementation too. A system that would offer the best of both worlds: a pre-configured, easy-to-deploy, electronic quality management system that could be tailored as and when the need arose. The introduction of X-Docs gave TrakCel a system that was compliant and user-friendly.

TrakCel drew up a shortlist after speaking to their clients and wider network within the life sciences industry. This shortlist included Formpipe’s X-Docs product. Formpipe also came in as a personal recommendation from senior management in TrakCel’s Clarity Compliance team. TrakCel’s Quality Assurance team also conducted extensive research into the best way to implement an EQMS system, the key challenge being trying to configure a system that paralleled their existing quality process.

Formpipe’s X-Docs product offers an easy-to-use EQMS solution that reflects current regulatory procedures for the FDA, MHRA and EU markets. Delivered on a stable Sharepoint platform, X-Docs offers pre-built modules and workflows that can be adopted Out of the Box or configured, meeting individual needs. TrakCel selected the pre-configured option, utilising the Docs, Train and Forms (for example CAPA and Change Control process) modules. The Formpipe modules are fully coordinated which offers a significant advantage over some of the alternative, well-known systems.

With their process management transformed, TrakCel have noted several benefits as a result. Firstly, the collaboration Standard Operating Procedures (SOPs) have seen an improvement, allowing feedback to be captured within the system, rather than emails and attachments being sent. Review and approval can also be simultaneously conducted by multiple approvers.

Electronic signature for documentation control means that workflow approvals are quick, without the need for paper being printed and transported around the offices. This provides a cost saving on how much paper is used each month, as well as an environmental benefit.

Through X-Docs, system templates can be set up for job descriptions, corporate CVs and competency records, presenting a professional image and processes that are more consistent. All training records were also visible and easily accessible to everyone.

The company have also noted several long-term benefits. When TrakCel initially completed a return on investment calculation, it was estimated that the transition to X-Docs would save the company a minimum of £3000 per month, based on time spent on paper administration.

The transition to X-Docs has meant that TrakCel now has a compliant, validated system that can help to avoid negative customer or authority audits. TrakCel have also noticed an increase in staff productivity as a result of using a more efficient system. X-Docs provides greater visibility in allowing access to documents, allowing data-driven decisions to be made. Using X-Docs has also improved the security of all TrakCel records.