Validation and Part 11 Services

Validation Life Cycle

With increasing regulatory scrutiny and requirements to comply with national and international regulations, more and more companies are moving to replace manual and paper-based processes with automated systems. Due to their experience and background, CIMCON Software Inc. (CSI) consultants are well equipped to qualify your systems of varying levels of complexity and help you stay compliant. CSI optimizes the time and cost of validation by applying a risk-based approach to each system. CSI can also provide a wide range of automated tools as part of the consulting engagement to provide you with sustainable compliance.

CSI is a recognized leader in providing compliance solutions to the FDA-regulated industry with a global client base that spans North America, Europe and Asia. CSI consultants combine regulatory knowledge with technical expertise to provide solutions to issues instead of simply highlighting them. CSI follows the FDA-recommended GAMP methodology for all validation services. CSI's validation methodologies have been developed after years of real-world field experience to ensure successful project outcomes. We strive to deliver value as an added ingredient in all our deliverables with a view to improving operations and productivity and simplifying processes with compliance as a by-product.

CSI offers a wide range of services that include validation planning, risk assessments, Part 11 assessments and remediation plans, preparation of validation documents and SOPs, protocol execution, deviation resolution and training. CSI regularly contributes to industry conferences, journals, tradeshows and events and is in tune with current FDA thinking and future direction.

Representative Projects

CSI follows the FDA-recommended GAMP methodology for all validation services. CSI's independent consulting services group has extensive experience in providing Validation and 21 CFR Part 11 Compliance services following GAMP 4 methodology that includes the following:

Validation Life Cycle
Planning
  • Master Validation Plan(MVP)

  • Risk Assessment

Requirements
  • User Requirements Specification (URS)

Design
  • Software Design Specification (SDS)

  • Hardware Design Specification (HDS)

Configuration
  • Hardware Configuration Specification (HCS)

  • Application Configuration Specification (ACS)

Specifications
  • Functional Specifications (FS)

  • Standard Operating Procedures (SOPs)

Testing
  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Performance Qualification (PQ)

Reporting
  • Summary Reports

21 CFR Part 11 Services
  • Strategy and Planning

  • System Inventory

  • Gap Analysis

  • Remediation

  • Technical Controls

  • Procedural Controls

Computer Systems Validation Experience - Representative Systems
  • Enterprise Resource Planning (ERP) Systems

  • Laboratory Information Management System (LIMS)

  • Document Management Systems (DMS)

  • Adverse Event Systems

  • Network Infrastructure Qualification

  • Laboratory Systems

  • Spreadsheet Validation

  • Plant Floor Systems

  • Equipment/Systems Validation

  • Label Management Systems

  • Manufacturing Execution Systems (MES)

  • Clinical Trial Management Systems

  • Source Code Reviews

  • Change Management Systems

  • Batch/Process Data Management System

  • Database Querying and Information Retrieval in a Controlled, Part 11 Environment

  • Computerized Maintenance Management Systems

  • Engineering Drawing Management System

  • Environmental Monitoring and Trending

  • Training Systems