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 / Computer Software Assurance

• 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.