Life Sciences – Pharmaceutical and Biotech
Ocean Data Systems Ltd. has created the ideal Report Generation and Data Analysis solution for Life Sciences. The Pharmaceutical and Biotech industries have the most demanding reporting requirements of any industry. We know – our customers have told us, guided us and helped us perfect Dream Report for your most demanding applications.
“Dream Report is designed for the pharmaceutical market by the pharmaceutical market.”
We listened to your needs and we’ve addressed them head on. Dream Report has all the tools required to build a 21CFRPart11 compliance reporting solution.
Security and accountability, guided by the Code of Federal Regulations, Book 21 and Part 11 (21CFRPart11), regulations are extremely important to most applications in this space. Dream Report isn’t a combination of business tools augmented with connectivity and automation to get by in these applications. Dream Report is a “Purpose Built” software product by a company that understands industry, your automation technologies, and your need for 24x7x365 reliability.
Dream Report delivers, for every application you rely on, and Ocean Data Systems stands behind every installation, and this product integrates with your plant floor systems.
Good Automation Manufacturing Practice (GAMP5)* relies on collecting data and, through the power of analytics, turning that data into knowledge. Then, using that knowledge to ensure product quality, process repeatability, batch documentation, and production releases.
Dream Report is the reporting and data analysis solution, perfectly addressing the needs of this demanding vertical.
Validation – Whatever system, Sterilizer / Autoclave, Freeze Dryer / Lyophilizer, Freezer, Refrigerator, Heat Tunnel, etc. Dream Report will interface with your data acquisition systems and data sources, what-ever the formats, and will generate the reports and knowledge you need. Dream Report will perform the analysis, select the Min and the Max, document the soak times, the stability, the repeatability and any other metrics that are important for your accountability.
Batch Reporting – A particularly challenging application, Dream Report will understand your systems, uncover batch IDs, evaluate start times, stop times and aggregate the results you need for your production release. Dream Report is Smart, and it is Capable. It will run automatically, but also gives you the power to select a report by Batch I.D. and rerun that report at any time. Do it from your Operator Station, or remotely from a Web Portal.
LIMS Reporting – Laboratory Information Systems need to be integrated with your Electronic Batch Records. Dream Report delivers the Manual Data Entry to make it all possible.
*- GAMP5 is a registered trademark of ISPE.org