Healthcare and Life Sciences

The pharmaceutical industry continues to evolve due to major parameters of influence such as changes in drug discovery process and sourcing, increasingly rigorous regulatory environments, pricing pressures in world markets and the world economy.

Hence the industry sees IT as a core component of its business now more than ever, and is looking to streamline and enhance IT to better support business needs. On the one hand, the pharmaceutical industry must try to leverage technology-driven productivity to drive down costs across the value chain, while on the other hand, minimize the inherent investment demands of IT projects.

Salient reasons attributed for the current challenges faced by the HCLS / Pharmaceutical industry are:

Blockbusters are harder to find as research and development (R&D) costs go up
Geographic differences affect firms’ globalization efforts
Despite or because of these changes, the sector continues to consolidate
Healthcare cost concerns put additional pressure on drug prices

AppLabs fully understands and appreciates that IT in the pharmaceutical industry is different, the single largest differentiator being regulatory compliance of services and systems . Our solutions approach addresses all the facets of challenges faced by the Healthcare and Life Sciences industry, be it R&D, reducing the cost of IT, reducing the cost of the business, supporting regulatory requirements, globalization and M&As.

AppLabs’ Healthcare and Life Sciences [HCLS] division offers specialized industry solutions in the validation and testing services sector. The solutions comply with regulations including FDA predicate rules, computer system validation, SoX, HIPPA, GxP, HL7, DICOM, 21 CFR Part 11, etc.

The HCLS team at AppLabs is certified and trained on an ongoing basis to ensure delivery and execution excellence within FDA and PhRMA regulatory mandates. The HCLS flexible models of delivery have enabled consistent and predictable validation services towards biotech, pharmaceutical, veterinary medicine, and medical device manufacturers for almost a decade.

AppLabs has now for more than seven years been delivering value to its HCLS customers in the field of medical devices testing, sophisticated LIMS testing, veterinary lab testing, chromatography data systems testing, certification of medical devices and laboratory instruments and other such pure play domain related verification and validation services.

AppLabs appreciates that Good Manufacturing, Clinical, and Laboratory Practice (GXP) requirements in the IT landscape has changed significantly in recent years. AppLabs’ Good Laboratory Practice experience ensures that there is adequate compliance to laboratory hazards management, lab material procedures and training guidelines, handling and storage regulations management etc. The AppLabs Good Manufacturing Practice experience includes environmental monitoring, site definition and management, samples management, tracking and recording results and reporting, instrument calibration management systems, and packaging and handling.

AppLabs understands the nuances of Healthcare framework particularly in the US, and the multiple changes that this area witnesses currently, such as ICD9-10 conversions, HIPAA 5010 migrations, and so on. With a mature team of subject matter experts constantly envisioning services in this arena, AppLabs HCLS remains in step with its customer needs and regulatory initiatives

AppLabs HCLS team has extensive experience in Computer Systems Validation, 21 CFR Part11 implementation wherein customizable audit trail mechanisms ensure traceability for any changes to electronic records throughout the drug discovery lifecycle. Stringent encryption algorithms ensure data security based on user security groups.

AppLabs has a mature and value driven framework in place catering to medical devices testing and certification. Our Certification Lab in Lindon, Utah test facility provides certification validation testing services of third-party hardware and software.

Our significant experience in the managed healthcare sector has been medical claims adjudication and authorization, data analysis for healthcare cost control, risk based testing of pharmacy benefits management systems, Health Insurance Portability and Accountability Act, Public Law 104-91, Information Security and Transactions under 45 CFR 160, 162, 164, HL7, DICOM based testing services and so on.

AppLabs' quality management and testing services utilize its many years of working with some of the largest Life Sciences and Healthcare organizations in the world. We understand that most systems have an impact on life critical decisions or products. Our experience across the globe ensures that we build on the experience to deliver high quality services to an industry sector that has no room for error.

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To find out more about our services, write to us at info@applabs.com.