• Commissioning & Qualification (C&Q)
• Computer Systems Validation
• Environmental (Temperature/Humidity) Mapping
• Medical Device Capabilities
• Construction Quality Assurance

Commissioning & Qualification (C&Q)

 
Performance Validation has successfully delivered numerous major facilities with an approximate value exceeding 540M USD.  We have experience in the development and execution of C&Q using the ISPE Baseline Guide(s), ASTM E2500 as well as developing C&Q programs tailored to conform with client policies, procedures and templates.

Services offered:

Performance Validation provides expertise with the following Commissioning and Qualification activities:

• Consultation including recommendations on client approach, best practices, benchmarking, audit and assessment of current practices

•  Turnkey Project Management and staffing of the entire C&Q effort

• Master plan (verification, commissioning, validation, project plan) development & implementation

• Risk Management

  • Per the ISPE Baseline Guide for system and component classification

  • Per ICH Q9 for the use of standard quality tools to facilitate risk based on scientific knowledge and protection of the patient

  • Per GAMP5 for the application of risk to automated or quality systems

• Development, training and implementation of Good Engineering Practices to support the commissioning effort

• Requirements & Specifications development

• Design/enhanced design review

• Vendor Management including audit, assessment, and testing

• Change management/ configuration management prior to system turnover and acceptance

•  Testing (Commissioning and Qualification, Verification, Validation, or other testing activities (FAT/SAT))

•  Formal release/turnover activities and System Acceptance

• Periodic Review (e.g., annual audit) of the qualified systems

Experience: Performance Validation has over 20 years of experience in performing C&Q projects for the following types of equipment and facilities.

Equipment & Equipment Automation

• Autoclaves
• Barrier Isolators w/sterility testing (VHP,ETO)
• Depyrogenation Ovens
• Fermentors
• Filling Equipment and Lines (complete filling lines/or individual components)
• Fluid Bed Dryers
• Glassware and Stopper Washers
• Lyophilizers
• Mills and Granulators
• Packaging Equipment and Lines (complete packaging lines/ or individual components)
• Pasteurizers
• Transfer Systems

Facilities

• Administrative Facilities
• Animal Heath Facilities
• Aseptic Facilities
• Bulk API Facilities
• Cell Culture Facilities
• Clinical Facilities
• DEA Vaults
• In Vitro Diagnostic Facilities
• Pilot Plant Facilities
• Quality Control Laboratories
• R&D Laboratories
• Solid Dose (Dry Products) Facilities
• Temperature controlled warehouses and production areas
• Walk in Freezers/ Cold Rooms

Utilities

• Clean out of Place/ Clean in Place Systems
• Clean Steam
• Critical Air and Gases
• HVAC systems
• Non Critical Utilities
• Water For Injection Systems

Performance Validation has successfully guided numerous clients though the current industry requirements for computer systems validation. We have utilized our trained professional teams to ensure that our clients' computer systems are thoroughly assessed and documentation is established to demonstrate that each computer system performs to specifications, in a consistent manner, and in compliance with federal regulations (e.g. 21 CFR Part 11, 21 CFR 820.70(i), and 21 CFR 211.68, etc.). Performance Validation has experience in the development and execution of CSV deliverables using the GAMP Guide(s), and current regulatory information as well as developing C&Q programs tailored to conform with client policies, procedures and templates.

Services offered:

Performance Validation provides expertise with the following CSV activities:

•  Consultation, including recommendations on client approach, best practices, benchmarking, audit and assessment of current practices

• Turnkey Project Management and staffing of the entire CSV effort

• Site or Global Computer System Validation Master Plan

• Validation Master Plan including life-cycle, security, data migration, business continuity/disaster recovery, and decommissioning governance

• Risk Management - utilizing the latest GAMP methodologies tailored to access risk of computerized sysetms

•  Development, training and implementation of Good Documentation Practices to support the validation effort

• Facilitate and document User Requirements & Functional/Design Specifications

• Software Vendor Management including audits and assessments

• Developing and implementing Change Management for the project/system

• Test Protocol development and execution including facilitating deviation resolution

• Periodic Review (e.g., annual audit) of the qualified system

Experience: Performance Validation has over 20 years of experience in performing CSV for the following types of systems.

Automation and Controls

• Building Management Systems (BMS)
• Environmental Monitoring Systems (EMS)
• Continuous Monitoring Systems
• Manufacturing Execution Systems (MCS/MES)

Information Management and Business Applications

• Computerized Maintenance Management Systems (CMMS)
• Quality Management Systems (QMS)
• Enterprise Resource Planning (ERP) Systems
• Laboratory Information Management Systems (LIMS)
• Record Imaging Systems

Environmental (Temperature/Humidity) Mapping

Services offered: Performance Validation offers the following services related to environmental mapping:

•          Consulting including characterization of equipment, permanent monitoring probes placement, temperature control and monitoring design recommendations, alarm strategies, MKT calculations and analysis, and mapping study design, development, and execution.

•          Document development and summary reports for engineering studies

•          Document development with respect to validation protocols, including requirements, design review, classification, qualification, and summary reports.

•          Execution of studies, and problem resolution assistance.

•          Project management and coordination of equipment, system, and facility validation

Qualification of Staff: All technical staff involved in performing mapping studies have completed formal training provided by Kaye, or have completed PV's internal training program on Kaye and Veriteq equipment.  Our internal operational procedures have been developed to ensure a consistent approach to equipment set up, operation and data retrieval. 

Equipment Availability: Performance Validation maintains an inventory of calibrated and validated mapping equipment to provide rapid response to your needs. Our equipment includes

•  100 Veriteq VL2000 data loggers

• 5 complete Kaye Validator 2000 systems

• 1 -  EZ Test incubator and associated Biological Indicators (for sterility assurance)

Qualification Templates: To provide cost reduction to our customers, Performance Validation has developed a number of validation templates which incorporate regulatory requirements and industry best practices.  Current templates that are available include:

•  Freezer, refrigerator, incubators

• Stability chambers

• Warehouse or production/manufacturing area

Experience: Performance Validation has significant experience in performing mapping studies and has completed numerous projects for the following types of equipment and facilities.

• Autoclaves / Depyrogenation Tunnels/ Ovens
• Refrigerators / Freezers / Incubators
• Liquid Nitrogen Cryogenic Storage and Freezers
• Vessels / Tanks / Filters / Fermentors
• Water Baths
• Stability Chambers

Facilities

• Walk in Freezers/ Cold Rooms

• Temperature controlled warehouses and production areas
• Environmental Baseline
• DEA Vaults
• Blood/Plasma Storage

Performance Validation has assisted US and Foreign device manufactures in meeting the US FDA and ISO 13485 requirements.  We have provided the following services to both large (Fortune 500) and small companies:

•  Quality system audits including:

  • Validation program (Governing documents such as production equipment qualification, facility qualification, process validation, cleaning validation, computer system validation, analytical   equipment qualification and methods qualification).

  • Completed qualification and validation packages.

  • Design History File

  • Change Control

  • Batch Record Reviews

• Validation Program development and implementation which provided an industry standard approach based on the concepts of GHTF, ICH, GAMP, ISPE, and ISO to meet the expectations set forth in the Quality System Regulations.

•  Development of Procedures that address other QSIT elements, including management controls, design controls, corrective and preventive actions, and production and process controls.  

•  Validation consultants - Key PV personnel who can provide an immediate influx of industry standard practice knowledge to your organization.   
  

•  Developing a quality manual and job specific project quality plan
• Introducing employees to quality tools.
• Working with the customer to apply those tools to specific jobs to manage quality on a project to project basis.
• Develop and implement audits, checklists and quality metric tools
• Developing standard operating procedures (SOPs) that define key processes and best practices.
• Introducing the use of risk management practices into the quality system.