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Businesses involved in areas such as the pharmaceutical sector must demonstrate the highest levels of compliance, traceability and quality.

Given the large volumes of documents generated by such organisations, important tasks such as keeping track of paperwork and ensuring compliance, can be extremely laborious and time-consuming activities.

To help overcome these problems and assist in a wide range of other organisational tasks, the implementation of modern compliance management software is proven to save time and money. Modern compliance management software increases businesses’ levels of efficiency and productivity, whilst also significantly improving conformance with compliance protocols.

A prime example of a business that has embraced the use of a premium quality compliance management software product, and is now reaping the multiple benefits of its use, is Oxford BioDynamics Plc.

A recent recipient of the prestigious Queens Award for Enterprise, Oxford BioDynamics Plc is a cutting-edge biotechnology company that is focused on the discovery and development of epigenetic biomarkers for use within the pharmaceutical and biotechnology industry.

The Company’s award-winning, proprietary technology platform, EpiSwitch™, aims to accelerate the drug discovery and development process, improve the success rate of therapeutic product development and take advantage of the increasing importance of personalised medicine.

Although, Oxford BioDynamics was previously using in-house developed document tracking systems, significant amounts of time were being wasted in areas such as the management and retrieval of information. Given the important work the company undertakes, to reduce the time spent by key members of staff performing tasks such as searching for documents, and to increase their available research time, a decision was made to investigate the available compliance management software products. Having considered and rejected several alternative electronic management systems, a chance meeting at an exhibition led to the discovering of Qualtrax compliance management software.

Oxford BioDynamics Plc. Chief Technology Officer, Aroul Ramadass explained. “Our proprietary technology platform enables pharmaceutical companies to reduce time to market, lower failure rates and cut costs at every stage of drug discovery and development. In addition, the technology provides significant insights into disease mechanisms for drug discovery and product re‐positioning programmes and also enables the personalisation of therapeutics for patients in the context of challenging pricing environments where improved clinical outcomes are critical.

“Given the huge amount of documents Oxford BioDynamics generate and the multiple process protocols we need to follow to ensure that we retain our important laboratory accreditations, the management of these functions was proving both time-consuming and inefficient. Now, the implementation of Qualtrax compliance software has given us the tools we need to improve the management of our systems and documents.

“Our conversion to the Qualtrax system was extremely smooth. Soon after the software’s installation a Qualtrax trainer delivered a very informative on-site training program. Although the software is wide-ranging and helps us in multiple areas, it is extremely logical and easy to use, so our staff soon became proficient in its use. Therefore, soon after training was completed, our staff quickly loaded our new software with their documentation and created workflows such as internal audits.

“Although Qualtrax software was able to satisfy all of our needs “out of the box”, its flexible nature means that we have been able to easily modify and fine-tune the system to exactly match all of our specific requirements. A particularly useful aspect of Qualtrax is its API capability, this enables the easy connection to other software and allows us to take data collected in Qualtrax and automatically populate pre-approved forms and reports. Our staff have become particularly adept at this.

“The API integration has particularly helped us in report generation and in the approval process. The experimental reports are generated dynamically while the process protocols are completed in the laboratory. The reports are then attached to the approval workflow by API. A collection of all reports generated for a project are then collated as part of a technical file for audit purpose. This aspect of the Qualtrax software alone saves many hours of report writing and has considerably increased our overall efficiency in generating technical files.

“In addition to ensuring compliance and adherence to our rigid quality systems, we also now use Qualtrax for duties supporting project management. Although we originally identified Qualtrax as an ideal, secure, logical and fast document control system that our staff would have full confidence in, since its implementation we have found numerous other uses for this powerful software”

Qualtrax compliance software is a simple but effective tool for streamlining and managing laboratory accreditations and audits. The flexible software combines a robust document control engine with automated workflows, standards-based auditing, and employee testing and training capabilities. Qualtrax is a true, all-in-one compliance solution for ISO and other quality standards, accreditation requirements and is an invaluable aid for managing both internal and external audits.

As a global leader in the field of compliance management software, Qualtrax provides users with a multitude of advantages, for instance, all documents are stored in a single location making document control infinitely more efficient. Only the most recent document version is accessible and readily available, also, if required documents can be set to “expire” after a certain amount of time, whilst electronic signatures are used to authorise approvals and create audit trails.

New workflow systems eliminate the hassle of paper and provide visibility of bottlenecks. In addition, paper-based business processes requiring approvals are automated through the use of email alerts. Items needing attention are held in one place and their priority is increased based on assigned due dates.

In the important area of standards-based auditing, each document is associated with specific sections of a chosen ISO standard and can be searched accordingly. System administrators are able to perform gap analyses to identify missing documentation, significantly reducing the time needed for both internal and external audits.

Training functionality supports internal & external courses with associated testing and competence sign off by managers. Competencies can be set to expire and be re-tested to ensure ongoing staff compliance. A training record is maintained for each employee.

Employee competence & compliance tests can be associated with any document revision to ensure acknowledgement and comprehension of laboratory policies and procedures.Free Trial CTP

Categories: Compliance Management, Process Management

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