Grow with confidence,
outsourcing the best validation resources.

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.  Bring us the opportunity to help you. 

  • 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

Computer System Validation 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.

Bring us the opportunity to help you.

It may includes:

  • 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

We have 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.  Bring us the opportunity to help you. 

  • 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

CAPA and regulatory Compliance Services

CAPA investigations: 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, Change Control, Risk assessments, 21 CFR part 11 gap analysis, system classification and system compliance plans for the pharmaceutical companies.

 

It may includes 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.
  • Annual Product Reports:

    data analysis, trends and annual product review.

training services

We can provide different kind of training and assessments to support and improve your quality Systems.  The most popular training are: cGMP, GDP, ISO13485, ISO14644, LEan manufacturing, Validation, CAPA investigations, etc.

Bring us the opportunity to help you.

  • Regulatory Compliance, QSR, cGMP, ISO, USP, etc
  • Project Management & Six Sigma Black Belt
  • Annual Product Reports
  • ECA Environmentally Controlled Rooms
  • Investigation Reports & Change Control
  • CAPA Investigations & OOS Reports
  • Risk Assessments – Regulatory
  • QA Regulatory Audits and others

for Pharmaceutical and Medical Devices Companies

Free Offers for pharmaceutical, medical devices, Research and development companies.

  • We have time limited offers and discount for new and existing clients. 

Discounts on Validation Instrument Leasing

Also, WE HAVE TIME LIMITED OFFERS AND DISCOUNT FOR NEW AND EXISTING CLIENTS on calibrated GE KAYE Validator 2000, IRTDs, Temperature baths, Chart Recorders, dataloggers, etc..

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