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 several books with Janet Gough, including:

Software as a Service - Risk-Based Validation with Time-Saving Templates

Software as a Service
Risk-Based Validation
with Time-Saving Templates

NEW for 2020!

Managing the Documentation Maze
Managing the Documentation Maze

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

See the Books page for more information and to order.