Text Box: Validation Engineering Services Text Box: COMPUTERIZED SYSTEM VALIDATIONS: Text Box: PROJECT MANAGEMENT & SIX (6) SIGMA BACK BELT TOOLS Text Box: ANNUAL PRODUCT REPORTS: Text Box: INVESTIGATION REPORTS & CHANGE CONTROL:

Corporate tel: 787-892-0516

Corporate fax: 787-892-3521

E-mail:

 
Text Box: Equipment Leasing: GE KAYE Instrumentation & Sensors:

   Engineering Commissioning: SATs and FATs

   Equipment Qualification: IQ, OQ, and PQ

   Computer Validation: VP, URS, FRS, TM, IQ/OQ/PQ

   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

   Cleaning Validation

   Black Belt Tools and Six Sigma Support—

Reduce cost and increase profits using Lean Manufacturing &

6 Sigma Black Belt techniques and tools.
Text Box: Job Opportunities Text Box: Research Opportunities: Text Box: 6 Sigma Black Belt:

PROJECT MANAGEMENT:

  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

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—

SERVICES BRIEF DESCRIPTION: CIQA 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. We offer a wide range of quality validation services to the Pharmaceutical Industry since 1996.  We can prepare the validation protocols, calibrations, trials, statistical analysis using Back-Belt tools, final reports and all the documentation needed to meet your schedule within budget.  Our validations are fully guaranteed, and meet new FDA & USP requirements.

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.

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.

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.

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.