Computer System Validation
MEDVACON delivers leading Compliance and Computer System Validation services that are designed to help reduce the overall cost of compliance for Life Sciences organizations. We offer our clients comprehensive services, including leadership and a range of strategic solutions and tactical services that provide cost-effective and comprehensive compliance and validation. The MEDVACON team of highly-qualified consultants can deliver a broad suite of solutions in areas of computer systems validation, infrastructure qualification, IT Quality Management, and process improvement.
Our Computer System Validation Experts Can Assist in The Following Areas:
- Risk-Based Computer System Validation
- Software QA and User Acceptance Testing
- Software Vendor Audits
- IT Policies and Procedure Development
- Gap Assessments and Remediation
- SDLC Methodology Development
- SOP Development
- Project Management
- 21 CFR Part 11 Compliance and Assessments
Section 4. The FDA and other regulatory bodies require validation to demonstrate that computer systems are in compliance with all regulations for electronic
data management systems. Failure to validate systems is one of the leading reasons a business is issued a 483. MEDVACON can validate all of your software, databases, spreadsheets, and computer systems, and develop the appropriate documentation for all phases of the software life cycle. We have written and executed validation packages for systems of all sizes. We can provide any level of service required, from executing test scripts generated from your existing specifications to writing the entire validation package. MEDVACON will follow your existing validation procedures or provide your company with validation standards. Our validation methodology ensures validation deliverables that are in line with industry standards & best practices, focus resources towards the most critical system functions, and complete the validation projects efficiently.
Example Projects
Lab Systems Software Implementation & 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:
- User and Functional Requirements (URS/FRS)
- Traceability Matrix (TM)
- 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
CSV Methodology Assessment 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.
CSV Methodology Assessment 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).
QMS Software Quality Assurance & Validation
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.
PDMA Sample System Validation
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.
Pharmaceutical IT Policies & Procedures Development
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.
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