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Formpipe Software AB
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TrakCel is a UK-based technology company that specialise in the development of cellular orchestration software for the planning and efficient management of cell and gene therapies at clinical trial and commercial scale.

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TrakCel Elevates its Document Management with X-Docs

The business has experienced rapid expansion and realised they needed a more efficient way of managing documentation approvals and accessing quality process data.

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.

Standard Functionality Challenges

TrakCel encountered functionality challenges in their existing system as it was a manual, paper-based approach. This proved to be labour-intensive and time-consuming. As the business expanded, it became apparent that using a paper-based system was increasingly challenging for teams to manually manage documents and the associated approval workflows.

With a clear mandate to deliver value, drive efficiency at every opportunity and a dedication to continuously improve processes across the company, TrakCel decided to assess their current methods of quality assurance and compliance management.

Research and Selection of X-Docs

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.

Implementation & Features

Performing demonstrations were fundamental in the decision-making process for TrakCel. Formpipe presented their processes and offered an audit. Formpipe offered TrakCel the opportunity for a true partnership relationship with support functions in place. Support was paramount to TrakCel as their Quality Assurance team were keen to add further configuration, allowing extended system use. The X-Docs solution is scalable and has a full and filterable audit trail, cross-modular functionality and a proven migration path. X-Docs also has FDA CFR 21 Part 11 compliant electronic signature features built into all modules. TrakCel currently have 90 users in their business who will use X-Docs, with the system being utilised to control various documents. By changing to X-Docs, TrakCel’s system became efficient and compliant with GMP.

Benefitting from improved quality assurance and compliance management

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.

TrakCel's Successful Transition to a Paperless System and the Positive Impact on Staff and Operations

Having visibility of metrics ensures swift reporting and trending, making the management review process for the Quality Assurance team much quicker.

The live status and the owner of all CAPAs (corrective and preventive action) and linked actions are visible to all, with the reporting dashboard identifying those approaching their due date with a Red-Amber-Green (RAG) status. Periodic reviews due are flagged automatically, rather than the teams having to monitor a spreadsheet.

Overall, TrakCel is seeing much greater savings than predicted. Being paperless has reduced paper and printing costs by a minimum of £4,000 for TrakCel per year. Implementing the new system means TrakCel will not incur off-site storage costs long-term. Kirstie Kay, Head of Quality at TrakCel comments,

“We have established a great relationship with Formpipe, and they have listened and understood our requirements, maintain regular contact and any support has been very responsive. The EQMS has exceeded my expectations in terms of efficiency and has allowed Quality Assurance to focus on value-added tasks rather than paper administration. Having a paperless QMS has allowed the entire company to work compliantly from home if needed”.

“The introduction of the EQMS has changed core aspects of my role,” says Susan Preston, QA Administrator. Previously much time was spent on the administration of paperwork, such as chasing paper copies from desk to desk to get signatures and the process of introducing/ superseding/ obsoleting paper copies of documents. This is now a much more streamlined process and fewer bottlenecks occur. Reviewing the status of training tasks and ensuring completion of training now takes significantly less time. The increased visibility and efficiency of the system has enabled me to concentrate and expand upon other aspects of my role”.