Quality + Compliance

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Strategic Maintenance Solutions employs a staff of validation consultants with extensive experience in Life Science EAM systems compliance validation.

Strategic Maintenance Solutions offers validation and regulatory consulting services. Combining the GAMP life-cycle validation methodology with strong internal procedures, Strategic Maintenance Solutions’ team delivers flexible and diverse validation packages. Strategic Maintenance Solutions has developed a process and a suite of services designed to ensure that our clients are in compliance with the applicable sections of the cGxP and 21 CFR Part 11. The process will assure the quality of the computerized system through the development and/or execution of requirements, specifications, design, coding, testing, installation and acceptance. This process includes the following steps customized to your unique needs:

  • 21 CFR Part 11 Audits/Remediation Plans
  • Client Validation Life Cycle Audits
  • Policies and Procedures Developments
  • Software Validation
  • Validation Plans
  • Disaster Recovery Plans
  • Operation and Security Procedures
  • Change Management and Control
  • System User Requirements and Design Documents
  • Protocols, Test Plans, Test Scripts

Our broad capabilities encompass master plans, 21 CFR Part 11 gap analyses, specifications, as well as protocol development, execution and summarization. We have extensive experience with computerized systems used in manufacturing, quality assurance, and document management. We can validate systems prospectively or retrospectively, for off-the-shelf software, configurable software, or custom designed software. Our experienced team assists clients with the validation of enterprise-wide IT installations, including servers, network hardware and applications. Additionally, our experience allows us to perform audits on computer system validation projects.

Strategic Maintenance Solutions’ computer validation group consists of individuals with experience in both regulatory compliance and information technology. The computer validation group’s experience spans a wide range of computerized systems and applications. The consultants are keenly aware of the ever changing technological and regulatory challenges our clients are faced with. Strategic Maintenance Solutions is strategically positioned to deliver high impact professional services to our clients.