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| Life Sciences |
The Life Sciences practice at Blue Marlin Systems provides validation and technical support to assist our clients in complying with International and US FDA regulations, such as 21 CFR part 11. The practice works closely with our regulatory and technical partners to assess, implement and remedy infrastructure, software, assets and sites subject to regulatory processes. |
| Service Offerings |
| Category |
Service Offering |
| ASSESSMENTS |
| Compliance Analysis and preparing Master Validation Plans |
| lQ/OQ/PQ Protocols and Final Reports |
| Vendor Audits |
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| IMPLEMENTATION AND REMEDIATION SERVICES |
| ERP Systems - SAP, ORACLE, JDE |
| Factory Automation, Electronic Batch Recording and MES Systems |
| Document Management Systems - Documentum, FileNet, WORD |
| Laboratory Information Systems |
| Database Management - ORACLE, SQL Server, ACCESS |
| Spreadsheets - EXCEL, LOTUS |
| Electronic and Digital Signatures |
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| TRAINING |
| Assessing your ERP Installation for Part 11 Compliance |
| Compliance procedures for Clinical Supply Chain processes |
| IT Programming techniques for Part 11 environments |
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| In the news |
| Feb 19-21, Anaheim, CA |
| BLUE MARLIN and BROOKS-PRI (NASDAQ:BRKS), large factory automation vendor team up at Medical Design and Manufacturing Exposition Device show |
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| Key Relationships |
| AAC Consulting Group, Inc, one of the largest global providers of FDA regulatory services is partnering with Blue Marlin Systems to expand their services for computer system validation. (read Press release) |
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21 CFR Part 11
Competency Center |
| Did you know the Life Science practice maintains an extensive library of |
- Best practices
- Methodologies
- Whitepapers
- System specific Templates for Test scripts, plans etc.
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