Global Compliance Group
Our Services
Global Compliance Group offers professional design, installation & startup, commissioning, verification/qualification, and auditing/remediation services to the life sciences industry. Global Compliance Group has experience with risk-based approaches to deliver projects on time and under budget without sacrificing quality. Our services are planned and executed by seasoned professionals who are Subject Matter Experts (SMEs) with technical expertise specific to the industries we serve. We offer skills and expertise for a wide range of services throughout the entire life cycle of complex projects - from discovery to delivery.
Installation and Start-Up Commissioning
Our team will work with your team to accomplish installation and start-up commissioning of manufacturing systems and equipment. Our installation and start-up commissioning services includes the generation and execution of factory acceptance testing (FAT), site acceptance testing (SAT) and commissioning protocols/checklists. During our installation and start-up commissioning all activities are documented using good documentation practices and troubleshooting is completed so that assurance of all open items are suitably resolved prior to verification of the systems' critical aspects. Our installation and start-up commissioning services include:
Design Reviews
Factory Acceptance Tests (FATs)
Receipt and Inspection and Site Acceptance Testing (SAT)
Commissioning Protocol/Checklists
Punchlist Management
Spare Parts Assessment
Verification/Qualification and Validation
Our Verification/Qualification and Validation Consulting services include:
User Requirement Specifications
Function Requirement Specifications
Design Specifications
Impact and Risk Assessments
Validation Master Plans
Installation Verification/Qualification
Operational Verification/Qualification
Performance Verification/Qualification
Process Performance Qualification
Cleaning Validation
SOP Generation
Change Control Assessments
Deviation/Investigation Management
We have experience with generating and executing verification/validation documents on various facility and process equipment and systems. We have also completed qualification projects for biotechnology, pharmaceutical, and medical device clients in following service areas:
Facility Utilities and Equipment Commissioning and Verification/Qualification
Analytical Instrument Qualification
Cleaning Validation
Process Validation
Computerized System Validation
Global Compliance Group offers a critical component of the Life Science Cycle with its Computerized System Validation services. We understand how crucial it is for computerized systems to help detect and stop any issues that could have negative consequences for the end users of a product as well as violate the strict FDA guidelines on manufacturing. Our consultants have in-depth life science industry specific knowledge in computer systems to ensure your needs are being met.
21 CFR Part 11 Compliance
As Part 11 guidelines continue to develop Global Compliance Group is your solution to advise and contribute regulatory solutions on Part 11, CAPA, and Risk Based Approaches to compliance.
Compliance Auditing/Remediation Services
Global Compliance Group provides quality & compliance auditing and remediation services to clients who are seeking a compliance assessment in areas including but not limited to internal and external quality, software development life cycle processes, manufacturing and laboratory operations, IT data center operations and governance, and computer system validation. Our audit personnel seek to assess and understand your organization's risks, and review your (or your supplier's) internal SOPs, software development procedures, and documented evidence of adherence, in order to assess the overall level of compliance. Since our consultants have had “hands-on” experience with FDA regulators, our audit processes are informed by the most current industry standards and are fully customizable to target your organizational needs. We will organize a well-defined remediation plan to address any gaps in compliance or FDA observations/citations.
The audits review documentation and focus on:
Accuracy/reliability
State of Control
Clarity/Comprehensiveness
Completeness/Appropriateness
Compliance
Quality Systems Implementation Services
Global Compliance Group provides quality system review services to clients who are seeking a compliance assessment, development, and/or augmentation of programs or procedures that are essential for success in regulated life science operations. GCG can assist in areas including but not limited to the following:
Change Control Programs
Standard Operating Procedure (SOP) Generation
Manufacturing-related Programs
Corrective and Preventive Action (CAPA) Programs
Quality Assurance and Quality Control Programs
Validation Programs
Training Programs