Application Validation
It has become increasingly difficult for organizations to meet the stringent requirements of many regulatory agencies from the financial auditors including the SEC (Sarbanes-Oxley) to Drug regulators including FDA and MCA.
THINQ has extensive experience within the Life Sciences industry especially in meeting the critical compliance requirements of the FDA and similar regulatory agencies.
Using a methodology based on ISPE's GAMP4, THINQ provides documented evidence that an organization's computer based applications are configured and used according to all applicable regulations.
Satisfy any auditor, whether internal or external using the SAME documentation, and supported by THINQ's Compliance Manager software if necessary.
Application Experience |
Approach |
Laboratory Information Management (LIMS)
Document Management (eDMS)
Enterprise Resource Planning(ERP)
Warehouse Management |
Project Management
Risk Assessment
Functional Requirements Analysis
System Configuration
Procedural Documentation (SOP's)
Test Protocols (IQ, OQ, PQ)
Reporting and Project Audit |
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