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Easing Regulatory Submission in Bioanalysis

Designed to improve lab productivity and efficiency, laboratory information management systems (LIMS) have proven beneficial in keeping track of data related to samples, instruments, and workflows of a lab. However, laboratories face challenges when it comes to bioanalysis and regulatory submission of documents with most LIMS available today. Off late, lab experts spend more time on non-science related work when it comes to bioanalysis to maintain data integrity of documents as prescribed by the FDA. Realizing similar challenges during LIMS implementations with pharma companies, Norbert Bittner along with the team at up to data, a provider of high quality IT services for the pharma industry, sought to change the scenario. Serving the pharma industry for over 25 years, the company enables laboratories to go beyond assembling and storing data by leveraging deep knowledge to evaluate and process data without the need for a data scientist. In addition, the company offers a bioanalysis product, iStudyReporter that automatically generates complex study reports and approval documents within minutes. “We help clients streamline processes and free them from manual reprocessing of data, which is time-consuming and tedious,” says Bittner, Managing Director, up to data.

iStudyReporter solution provides a simple way of generating regulatory bioanalytical documents such as validation and analytical reports while eliminating the need for manual steps, table formatting, and complex checks to ensure data validity. The solution automates lab procedures from creating approval documents to submission. “We are addressing client’s initiatives from early stages where data is drafted to the late stage where complete documents are submitted for complete data integrity that saves a lot of time,” remarks Bittner.

We help clients streamline processes and free them from manual reprocessing of data, which is time-consuming and tedious

Besides, ensuring data integrity, the documents generated by iStudyReporter are compliant with international regulations and statutory requirements. In fact, the solution is compliant with the FDA’s 2018 guideline on bioanalytical method validation as well.

To illustrate the effectiveness of iStudyReporter, Bittner cites the success story of a large pharmaceutical company, Boehringer Ingelheim. The client implemented LIMS which did not provide adequate automation for generating the required regulatory bioanalytical reports. With up to data’s iStudyReporter’s seamless integration with their LIMS, Boehringer was able to effectively generate bioanalytical reports while automating and validating workflows. The client was able to meet all its specification and target processes quickly.

Owing to its rich experience in laboratory management, up to data is well versed with the laboratory processes of different industries and the requirements for a LIMS. “We have a team with a strong scientific background that adds significant value to our products and services,” says Bittner. Leveraging the technical and scientific experience of the team, up to data helps clients to optimally configure their LIMS for business processes. With an aim to create a homogenous IT infrastructure with interconnectivity to make the best use of the resources available, up to data offers a complete service portfolio for the entire life cycle of a LIMS from design and implementation to operation and administration. The company operates according to established concepts, methods and standards such as ISO 9001:2015 and GAMP. At the same time, up to data is aware of the standards and regulatory guidelines that clients need to comply with.

Continuing with such deep expertise in the LIMS and pharma arena, up to data will enhance its iStudyReporter by adding new features and functionalities. With continuous research and development backed by the team’s combined experience, up to data plans to develop a new set of tools. Partnering with companies that complement its solutions, up to data is on its way to commence a new corporation to expand its global footprint with advanced, integrated solutions in the pharma space.