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Validation Services

Validation Engineering Services

We offer a wide range of professional services in the validation and engineering field that include, but not limiting to: validation master plan, user requirements, design specifications, installation, operational and performance qualification. In addition, we can prepare traceability matrix, gap analysis, risk assessments, system compliance plans and other regulatory compliance documents as investigations, etc.

  • Equipment Qualification: IQ, OQ, and PQ
  • Computer Validation: VP, URS, FRS, TM, IQ/OQ/PQ
  • Cleaning Validation
  • Process Validation (IQ/OQ/PQ)
  • Change Control
  • Engineering Commissioning: SATs and FATs
  • Utilities Qualification: HVAC, Compress Air, etc.
  • Facilities Qualification: FQ
  • Process Validation, re-qualification: IQ/OQ/PQ
  • Design Qualification: - DQ
  • Investigations, SOP,s, PM, Spare Part List
  • Thermal Mapping & Sterilization Runs
  • Packaging and Process Validations
  • Lyophilization Validation
  • Black Belt Tools and Six Sigma Support
  • Design control procedures and implementation
  • Design control audits
  • Design development plan
  • Design control project management
  • DMR (device master record)
  • Risk management program development and implementation per ISO 14971:2007
  • Risk Management Plans and Reports
  • Risk analysis
  • Failure modes and effects analysis (FMEA)
  • Fault tree analysis (FTA)
  • Preliminary hazard analysis (PHA)
  • Health hazard evaluation (HHE)
  • Medical Device product design history file compliance
  • Biocompatibility and sterilization assessment
  • Medical device standards assessment

Computerized System Validations Services

The quality of your product or service depends on the capability of the systems that support your processes. Therefore, to successfully comply with the regulatory agencies such as FDA, etc, you must ensure that your systems work in accordance with the manufacturer's design specifications and comply with all user expectations. We rely on the most highly qualified personnel to help you reach this goal.

  • Change Control
  • Validation Plans - Design Qualification
  • Users Requirements Specifications (URS)
  • Functional Requirements Specifications (FRS)
  • Traceability Matrices
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Final Closure Reports

Project Management & Six Sigma Black Belt Tool

CIQA possess strong experience managing projects using Microsoft Project for Windows or Primavera in the client site to define the tasks, schedules, milestones and other project descriptions. Statistical analyses previously performed are: ANOVA Analysis of Variances, DOE, T-Tests, F-Tests, Central Tendency, Variation, Correlation, Regression, Linearity, Capability Analysis, Taguchi Method and many others.

  • Project Planning & Presentations
  • Project Management & Control
  • Construction Supervision
  • Commissioning Activities
  • Consulting Project Auditing
  • Maintenance Services
  • Safety and Health Security Management
  • Pest Control Management
  • SOP & Preventive Procedures Preparation
  • Control System Installation/configuration
  • Cost Analysis Management

Environmental Qualifications Services of ECA Environmentally Controlled Rooms

We provide environmental monitoring and qualification services to clean room or environmentally controlled rooms that need to comply with the ISO 14644. We can generate the qualification protocols, make the measurement using our calibrated and validated instrumentation using innovative data gathering devices to collect all necessary information about: temperature, % relative humidity, particles, etc. Finally, we provide the supporting data gathered in summary table with the corresponding statistical results and a closure final report with all findings obtained.

Implementation & Customization Services

We offer a wide range of professional services in the implementation, customization and validation that includes, but not limiting to: regulatory compliance services and preparation of validation master plan, user requirements, design specifications, installation, operational and performance qualification. In addition, we can prepare traceability matrix, gap analysis, risk assessments, system compliance plans and other regulatory compliance documents as investigations, CAPA’s, FMEA’s, SOP’s, etc. We can prepare the validation protocols, trials, statistical analysis using Black-Belt tools, final reports and all the documentation needed to meet your schedule within budget. Our validations are fully guaranteed, and meet new FDA, ISO & USP requirements.

Supporting Services:

Investigation Reports & Change Control

Investigation reporting for the FDA regulated industries in specialized areas such as: FDA preparation or simulation audit, cGMP's, in-coming, vendor certification, computer validation 21 CFR part 11, 211 or 820. Extensive experience in the preparation of investigations, Risk assessments, 21 CFR part 11 gap analysis, system classification and system compliance plans for the pharmaceutical companies.


Annual Product Reports

CIQA has extensive experience performing data analysis, trends and annual product review. In addition, we help you in site-to-site technology transfer and prepare laboratory certifications for instruments and analysts.


Regulatory Compliance:

  • CAPA Investigations & OOS Reports
  • Risk Assessments - Regulatory
  • Annual Product Reviews
  • QA Regulatory Audits & Trainings
  • PAT Implementation
  • Counterfeit Prevention & Investigations
  • Calibration Program Assessments
  • Recall Investigations
  • Final Summary - Executive Reports