Automated RMMs are particularly valuable if they can be seamlessly integrated into a Laboratory Information Management System (LIMS) like the Growth Direct® System can. LIMS-integrated instrumentation vastly improves data integrity and transparency, while also offering potential cost savings.[iv] Since data integrity is central to site compliance,[v] this careful management of data goes a long way towards reducing patient risk and satisfying regulatory requirements. Furthermore, LIMS-integration also contributes to faster time-to-results and quicker detection of contamination issues.
For more information, download our whitepaper on the value of advanced QC microbiology testing for contract manufacturers. If you are curious about what the Growth Direct® installation process looks like, check out our blog on frequently asked set-up questions.
[i] ISR Reports. Sterile Injectable Drug Product Manufacturing. Outsourced Pharma. https://www.outsourcedpharma.com/doc/sterile-injectable-drug-product-manufacturing-market-overview-and-outlook-0001. Published March 11, 2021. Accessed August 30, 2021.
[ii] Connell B. Build CMO Relationships with Effective Management Practices. PharmTech. 2020; Supplement (3):s26–s28, s33. https://www.pharmtech.com/view/build-cmo-relationships-with-effective-management-practices
[iii] Alghabban A. What to Look for in Selecting a CRO/CMO and How to Ensure the Right Choice: A Quality Assurance Perspective. Pharmaceutical Outsourcing. https://www.pharmoutsourcing.com/Featured-Articles/172751-What-to-Look-for-in-Selecting-a-CRO-CMO-and-How-to-Ensure-the-Right-Choice-A-Quality-Assurance-Perspective/. Published March 25, 2015. Accessed October 12, 2021.
[iv] Carra N., Makarova E., Morell J., Ringel M., Telpis V. Digitization, automation, and online testing: Embracing smart quality control. https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/digitization-automation-and-online-testing-embracing-smart-quality-control. Published April 14, 2021. Accessed August 30, 2021.
[v] Parenteral Drug Association, Inc. Data Integrity Management System for Pharmaceutical Laboratories Technical Report No. 80. https://www.pda.org/bookstore/product-detail/4542-tr-80-data-integrity-management. Published August 2018. Accessed May 13, 2021.