Computer System Validation

MEDVACON's pharmaceutical client anticipated deploying Waters Empower 3 Chromatography software in their facilities for use with approximately 30-35 HPLCs.  To ensure compliance with current Good Manufacturing procedures pharmaceutical client engaged MEDVACON to perform Computer System Validation to successfully implement sophisticated software capabilities.  MEDVACON structured the project  scope of work,  by preparing: 

1. User and Functional Requirements (URS/FRS)
2. Traceability Matrix (TM)
3. Review Waters vendor software testing documentation per Detailed Design Specifications (DDS)

• Software Modules
• Graphics
• HMI components and batch reports
• Review Configuration Specification/DDS documents
• Author and launch IOQs for the Waters Empower 3 Chromatography Data Software Author IQQ Summary Report, and Author and launch PQ for the Live Environment
• Author and Launch Data Transfer and Integrity Testing Protocol for Transfer of Data from Empower 2 to Empower 3

Project 1:

MEDVACON engaged in a multifaceted compliance consulting initiative to provide professional consulting services to ensure 21 CFR Part 11 compliance, requisite System Development Life Cycle (SDLC), and Validation. MEDVACON  provided written 21 CFR Part 11 compliance assessment reports for the five types of computer controlled test equipment;

• Written assessment report of the client site IT Policies & Procedures to ensure 21 CFR Part 11 compliance controls 
• Written assessment report of site IT policies & procedures governing their System Development Life Cycle (SDLC) methodology required for developing software used in a GxP environment
• Validation and 21 CFR Part 11 compliance consulting services specific to client's in-house developed MS Access-based test-data collection and reporting system. 

Project 2:

MEDVACON assisted an FDA lab staff by proactively identifying SOPs updates required for LIME during lab implementation. MEDVACON ensured that the LIMS-relevant SOPs from the labs and QMS staff and resources were available to complete instrument qualification, operational qualification, and performance qualification (IQ/OQ/PQ).

An industry leader in Quality Management software engaged MEDVACON in ongoing CSV, SQA, and project management activities. MEDVACON has a dedicated team that prepares and executes PQs for QMS providers' client implementations.  MEDVACON has another dedicated team that conducts full SQA and validation of QMS providers' quarterly software releases.  

MEDVACON's Prescription Drug Marketing Act (PDMA) sample compliance services client engaged MEDVACON to validate their acknowledgement of delivery tracking system. MEDVACON developed the project plan, validation plan, reviewed the URS and FRS, and develop the IQ/OQ and PQ.  MEDVACON executed the protocols and developed the validation final report. 

A pharmaceutical company developing small-molecule, anti-cancer therapeutics engaged MEDVACON to evaluate their existing IT policies and procedures and develop an overarching IT Quality System, along with development of requisite documents. MEDVACON developed sixty-four IT Polices, Procedures and Work Instructions which form the basis of their IT Quality System.