Services - FDA Compliance Consulting Services, 21 CFR Part 11
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.
- Determine the company’s current level of 21 CFR Part 11 and HIPAA compliance with respect to industry standards.
- Develop and execute strategies that achieve compliance.
- 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.
- 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 software vendors and check references.
- Audit SaaS and co-location vendors.
- Performed more than 65 vendor audits.
- 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 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.
- 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.
- Perform an inventory of all software, determine 21 CFR Part 11 and HIPAA compliance, validation assessment, and upgrade and replacement approaches.
- 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.
- Represent company during regulatory inspections.