This short video explains, in simple terminology,
what Computer System Validation is,
and how it saves your company money!



Computer System Validation provides a variety of services to help your company ensure compliance.

Cost-Reduction without Increasing Regulatory or Business Risk

  • Increase corporate productivity, and individual workforce member productivity.
  • Efficiently create validation documentation.
  • Determine risk in a process.
  • Write test cases that trace to elements of risk management.
  • Significantly lower costs and reduce software implementation time.

Gap Analysis

  • Determine the company’s current level of 21 CFR Part 11 and HIPAA compliance with respect to industry standards.

Remediation Plans

  • Develop and execute strategies that achieve compliance.

Business Development

  • Define product features, services, and marketing materials for regulated markets.

Computer Security Evaluations

  • Educate IT, management, and users of the current industry standards for computer security.

SOP Infrastructure

  • Develop SOPs that build infrastructure and ensure compliance: training, building security, network security, backup, archiving, system maintenance, change control, disaster recovery, electronic signatures, record retention, software procurement, software vendor auditing, user validation, developer validation.
  • Develop system-specific, process-level procedures and maintenance procedures that make efficient use of resources.

Audit Vendors

  • Audit software vendors and check references.
  • Audit SaaS and co-location vendors.
  • Performed more than 65 vendor audits.

Procure Software

  • Research the market for cost effective solutions and perform product comparisons.
  • Develop contracts for purchasing, installation, maintenance, and professional services.
  • Coordinate and perform hardware and software installation.

Project Management

  • Project management of all validation project details and team members.
  • Schedule project activities to adapt to the evolving business environment.
  • Budget and track project costs.
  • Supervise testing resources.
  • Manage system configuration.
  • Directly responsible to executive management for project completion.
  • Facilitate project teams consisting of as many as 45 members and 500 users.
  • Manage quality assurance activities for software development projects.
  • Direct development and acceptance activities for customized software.
  • Work on multiple projects concurrently.

Software Development

  • Manage all aspects of the SDLC and documentation including: user requirements, development project plan, design specifications, technical specifications, developer testing, code reviews, SQA testing protocol and report, product release.

Computer System Validation

  • Lead teams to write all validation and verification documentation and supply management with a finished product that is ready for FDA inspection.
  • Define user requirements.
  • Establish realistic goals and project plans.
  • Develop installation protocols, installation instructions, and verification test plans.
  • Translate requirements into specifications compliant with 21 CFR Part 11 and HIPAA.
  • Perform process-level risk assessment and hazard analysis.
  • Develop test plans, execute test cases, and approve test reports.
  • Approve all project documentation and complete system release.
  • Verify systems are functioning as intended after implementation.
  • Actively participate in the hands-on validation activities.
  • Successful implementation of more than 100 software projects.
  • Reduce costs by detecting defects in software and processes before production use.
  • Validate customer complaint systems and resolve issues to ensure customer satisfaction and process correction.

Inventory Software

  • Perform an inventory of all software, determine 21 CFR Part 11 and HIPAA compliance, validation assessment, and upgrade and replacement approaches.

Training

  • Coordinate, supervise, and train Information Technology (IT) staff.
  • Write training plans and train users at all levels; customers, users, management.
  • Hired and trained more than 40 technical staff.
  • Conduct process improvement training.
  • Develop customized in-house training programs.

Computer System Validation Team (Part 11 Committee)

  • Add value to organization by adopting software that increases productivity and quality.
  • Encourage the adoption of software as enjoyable and rewarding.
  • Make software implementation a part of the organization’s culture so that new software systems and upgrades are readily adopted.
  • Develop automated document control systems and procedures.
  • Solve problems by learning the business processes and viewpoints of customers, users, developers, testers, management, and regulatory bodies in order to communicate technical details between all parties.

Inspections

  • Represent company during regulatory inspections.

David's Books

One of the nation's foremost experts on CSV for 21 CFR Part 11, David Nettleton has written four books with Janet Gough:

Risk Based Software Validation
Risk Based Software Validation - Ten easy Steps

Electronic Record Keeping
Electronic Record Keeping; Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164

Managing the Documentation Maze
Managing the Documentation Maze
Read a Review

Commercial Off the Shelf COTS Software Validation
Commercial Off-the-Shelf (COTS) Software Validation for 21 CFR Part 11 Compliance

See the Books page for more information and to order.