GMP Validation and Regulatory Compliance

Enjoy a 100% customer satisfaction, or money back of your investment guaranteed on 30 days.


Consulting Services in Puerto Rico,
since 1996.

We can help you with every GMP need.

Grow with confidence, outsourcing the best GMP Validation and Regulatory Compliance services.

GMP Validation
ENGINEERING Services

We offer a wide range of professional services in the GMP validation engineering and regulatory compliance field. We can prepare 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.  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

CSV Computer System Validation
Computer System Validation of servers

Computer System Validation

The quality of your product or service depends on the capability of the systems that support your processes. Therefore, to successfully comply with the GMP regulatory agencies, you must ensure that your equipment work in accordance with the manufacturer’s design specifications. 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

GMP Project Management & Six Sigma Black Belt Tool

We have very strong experience managing projects using Microsoft Project to define the tasks, schedules, milestones and other project descriptions. Also, we master Minitab and other statistical analyses applications to perform: 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

GMP Validation representatives
GMP CAPA Description

CAPA and Regulatory Compliance Services

CAPA investigations: We can help you to prepare the incident investigation reporting for the FDA regulated industries. In addition, we have strong experience supporting FDA audit, cGMP’s, in-coming, vendor certification, computer validation 21 CFR part 210, 211, 600 or 820. Moreover, we have extensive experience in the preparation of robust investigations, Change Control, Risk assessments, 21 CFR part 11 gap analysis, system classification and system compliance plans.

 

It may includes CAPA Investigations & OOS Reports that support your validations and regulatory compliance areas such as:

  • 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.

GxP Training Services

We can provide different kind of training and assessments to support and improve your Quality Systems including GMP Validation and Regulatory Compliance.  The most popular training are: cGMP, GDP, GLP, 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

GMP Training representative

GMP VALIDATION AND REGULATORY COMPLIANCE SERVICES FOR

GMP Validation Regulatory Compliance services for Pharmaceutical and Medical devices Companies.

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

Validation Instrument Leasing with configuration, setup and preparation of reports included.

We have time limited offers and discount for new and existing clients on calibrated GE KAYE Validator 2000, IRTDs, Temperature baths, Chart Recorders, dataloggers and much more.

If you need talent management and temporary staffing services in Puerto Rico, contact us.

We can find the best professional resources for your company needs.