With the goal of innovating to provide better healthcare and increasing profit levels of stakeholders, Life Sciences industry strives to meet the multiple challenges of growing competition, ever increasing customer expectations, increasing R & D costs, fluctuating market conditions and pressure for regulatory compliances. All these have made Life Sciences companies to find new ways to cut cost by more focus on internal R & D, better marketing strategies and increased productivity.
In order to cope with the rapid changes within the Life Sciences organizations, the supporting IT systems need to have flexibility to manage the present changes with a scope to accommodate future changes. It becomes imperative that these Life Sciences IT solutions need to be of highest quality standards.
Aided by our rich experience in providing quality assurance of Life Sciences systems, Testree delivers premium testing and consultation services that help companies adapt to the changes in the Life Sciences landscape and confidently progress towards successful delivery of healthcare products and services.
Testree’s Life Sciences QA profile
We adopt a professional approach in testing Life Sciences IT systems taking into consideration the best practices and industry regulations. We leverage our modern tools and technology resources in performing validation of pharmaceutical solutions against various QA attributes like functional compliance, performance, security, scalability, device compatibility, interoperability and accuracy.
Our quality services cover a wide array of pharmaceutical solutions including
Clinical Trial Management
The perfect functioning of IT systems assisting in the development of life-saving drugs is absolutely critical. Our team validates various trial management systems like Study Management System, Site Management, Patient Enrolment and Management, Trip Reports thoroughly for data security, interoperability and accuracy.
Adverse Event System
We assess the adverse event and incident reporting systems to validate against ease of use, restriction of patients information to relevant departments and integration with other modules, quick reporting for analysis and prioritization of associated risks etc. We verify the automated report generation features, regulatory reports like MedWatch, CIOMS, 3500a Drug, 3500a Device etc. and audit trail and product tracking features.
Laboratory Information Management System (LIMS)
We test LIMS solutions for stability under concurrent usage, automation of report generation of email processes, portability of data into multiple formats etc. The various features that are covered under LIMS testing are Sample Collection, Sample Management, Sample Tracking, Data Processing / Reporting, Instrument and Application Integration.
Testree is well-versed with the various regulatory requirements of Pharmacovigilance like data confidentiality of patient information, translation into multiple languages for world-wide referencing and proper documentation of additional information related to adverse event reporting. We validate against industry standards like 21 CFR Part 11, REMS and RMPs. We provide verification and validation services for small and medium sized companies developing software for Pharmaceuticals and CROs for drug investigations.