GMP Validation and
Regulatory Compliance
Enjoy a 100% customer satisfaction, or money back of your investment guaranteed on 30 days.
Providing Consulting Services in Puerto Rico
and worldwide remotely, since 1996.
We can help you with every GMP need.
Grow with confidence, outsourcing the best GMP Validation and Regulatory Compliance services.
Validation Definition (US-FDA):
“Validation is the establishment of documentary evidence which provide a high degree assurance of specified process will consistently produce the product meeting with predetermined specification and quality attributes.”
“Validation is the establishment of documentary evidence which provide a high degree assurance of specified process will consistently produce the product meeting with predetermined specification and quality attributes.”
Validation Protocol Definition:
"A written plan describing the process to be validated, including production equipment and how validation will be conducted."
"A written plan describing the process to be validated, including production equipment and how validation will be conducted."
User Requirement Specification Definition:
"The user requirement(s) specification (URS) is a document usually used in computer system validation that specifies what the user expects the software to be able to do."
"The user requirement(s) specification (URS) is a document usually used in computer system validation that specifies what the user expects the software to be able to do."
Installation Qualification Definition:
"Establishing confidence that process equipment and ancillary systems are compliant with appropriate codes and approved design intentions, and that manufacturer recommendations are suitably considered."
"Establishing confidence that process equipment and ancillary systems are compliant with appropriate codes and approved design intentions, and that manufacturer recommendations are suitably considered."
Operational Qualification Definition:
"Establishing confidence that process equipment and ancillary systems operate correctly within their specified limits consistently and dependably."
"Establishing confidence that process equipment and ancillary systems operate correctly within their specified limits consistently and dependably."
Performance Qualification Definition:
"Establishing confidence through appropriate testing that the finished product or process produced by a specified process meets all release requirements for functionality and safety and that procedures are effective and reproducible."
"Establishing confidence through appropriate testing that the finished product or process produced by a specified process meets all release requirements for functionality and safety and that procedures are effective and reproducible."
Process Validation Definition:
"Establishing by objective evidence that a process constantly produces a result or product meeting its predetermined specifications."
"Establishing by objective evidence that a process constantly produces a result or product meeting its predetermined specifications."
“… a product shall be deemed to be adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current GMP good manufacturing practices.”
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GMP Validation
ENGINEERING Services
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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.
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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
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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.
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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
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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.
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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
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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.
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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
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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.
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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 VALIDATION AND REGULATORY COMPLIANCE SERVICES FOR
Pharmaceutical Companies
Medical Devices Companies
Food Companies
Cosmetics Companies
Biological Companies
Hospitals Institutions
Healthcare Organizations
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 or worldwide, contact us.
We can find the best professional resources for your company needs.
The best GMP Validation Regulatory Compliance Services in Puerto Rico. Best outsourcing validation engineering companies in Puerto Rico.
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