Computer System Validation

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. 

How MEDVACON Helps With 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

Computer Software Validation is a formalized, documented process for testing computer software and systems, required by 21 CFR 11.10(a) and Annex 11, 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.

Example Projects

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.

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.

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.  

Computer System Validation 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). 

Computer System Validation 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. 

Lab Systems Software Implementation & Validation

MEDVACON’s client planned to deploy Waters Empower 3 Chromatography software across their facilities, utilizing it with approximately 30-35 HPLCs. To ensure compliance with current Good Manufacturing Practices (GMP), the client enlisted MEDVACON to perform Computer System Validation (CSV). This helped to successfully integrate and maximize the software’s sophisticated capabilities.

For this project, MEDVACON meticulously structured the scope of work, which included:

  • Developing User and Functional Requirements Specifications (URS/FRS).
  • Creating a Traceability Matrix (TM) to ensure all requirements are met.
  • Reviewing Waters’ vendor software testing documentation against Detailed Design Specifications (DDS).
  • Analyzing Software Modules, Graphics, Human-Machine Interface (HMI) components, and batch reports.
  • Examining Configuration Specification/DDS documents.
  • Authoring and executing Installation Qualification/Operational Qualification (IOQ) for the Waters Empower 3 Chromatography Data Software, along with the IQQ Summary Report.
  • Authoring and launching Performance Qualification (PQ) for the Live Environment.
  • Authoring and initiating a Data Transfer and Integrity Testing Protocol to transition data from Empower 2 to Empower 3.
Scroll to Top