Services

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Comprehensive Solutions

At HiCap Alta, our staff is composed of highly experienced, qualified, and committed professionals. Furthermore, they are experts in their respective fields. That is why we can provide the following services to you:

Commissioning and Qualification / Validation

Commissioning and Qualification (C&Q) presents a systematic approach to ensure that manufacturing requirements, specifications, and expectations are met.

HiCap Alta provides services and unparalleled support to ensure that our clients meet regulatory standards as they relate to design, installation, operation, and performance.

These services range in scope between facilities, building systems, and process equipment or instruments.

HiCap Alta offers proven expertise with end-to-end solutions across the lifecycle of C&Q:

Risk and Impact Assessment

Validation Master Planning

Document Generation

Protocol Execution

Approval and Final Release

Let’s explore the C&Q and validation services HiCap Alta offers:

  • Equipment Qualification (including Risk Based ASTM E2500)

    • Manufacturing
    • Packaging
    • Laboratory

  • Process Validation

  • Facility Qualification

  • Critical Utilities Qualification

  • Environmental Monitoring Performance Qualification

  • Cleaning and Sterilization Processes Validation

  • Factory Acceptance Testing (FAT)/Site Acceptance Testing (SAT) Support

  • Specialized Technical Services

    • Maintenance Systems
    • HVAC Systems
    • Environmental Monitoring

Computer System Validation and Automation Services

Computer system validation (CSV) is performed to increase reliability and reduce risks for a computerized or automation system.

HiCap Alta helps clients demonstrate data integrity and system robustness by developing and executing test scripts that detail system design, specifications, and requirements.

With our array of knowledge across multiple systems and infrastructure, clients can rely on HiCap Alta to fulfill their specific computer system needs.

We’ve shared a list of CSV and automation services that HiCap Alta offers:

  • Computerized Process Control Systems Validation (including 21 CFR Part 11 Assessment and Compliance)

    • Utilities
    • BAS
    • Process Equipment
    • Laboratory Equipment

  • Excel Spreadsheet Validation

  • List of Systems

    • Control Systems
      • DeltaV
      • Siemens
      • Rockwell
    • Data Historian Systems
    • Quality Management Systems
    • IT Infrastructure/Network Systems
    • Backup and Restore Systems
    • Virtual Machine Systems/VMware
    • Data Management Systems
    • CFR 210 and 211 Compliance

Project Management

Project management is a skillset that is essential in many projects that HiCap Alta supports.

Our consultants are able to effectively utilize tools and approaches in order to deliver excellent project outcomes.

HiCap Alta has the knowledge and expertise to engage key project stakeholders across multiple functions, including manufacturing, engineering, facilities, and quality.

We offer exceptional project management services:

  • Business Driver Development

  • Resource Loading

  • Budgeting

  • Timeline and Schedule Management

  • Risk Management

  • Audit Preparation

Quality Assurance and Regulatory Writing

To ensure that our clients’ products consistently meet site-specific and regulatory requirements, HiCap Alta provides comprehensive solutions that ensure quality and compliance.

The solutions vary across client activities from production support, including standard operating procedure (SOP) and batch record generation, to preparation for pre-approval inspections and regulatory audits.

The list of services that HiCap Alta offers for quality assurance is as follows:

  • Document Control

  • Change Control Management

  • Quality Assurance Plans and Reports

  • Corrective and Preventive Action (CAPA)

  • Deviation Resolution