OnLabs regulatory compliance services provides guidance and assistance to technology and manufacturing companies all over the world in stream-lining their regulatory compliance process. Recent developments in regulations mean that a structured sustainable process is now required. With compliance services you can avail of over 15 years of experience in Pharmaceutical manufacturing and compliance process management.
Our team has implemented quality assurance and compliance solutions for over 15 years and applies his knowledge and experience to enable organizations to manage the growing burden of regulations across all areas.
With extensive experience improving business processes for both efficiency and stronger customer service, our team has a good understanding of the challenges relating to compliance. Coming from a computer sciences background, we are particularly experienced in technically demanding and/or complex business solutions to blue-chip customers. We have worked with numerous companies in assisting them to examine existing business systems and implement process improvement and achieve staff buy-in.
Take a look at our services, references, solutions, proven records of success, expert knowledge, and our unending dedication to customer satisfaction to see why our clientele relies on OnLabs regulatory compliance services.
We offer cost-effective, readily implemented compliance options that rank among the best available on the market.
Everything we do is backed by broad-based expertise, problem-solving methodology and smart solutions. Four of the top five pharmaceutical and biotechnology companies take advantage of our unmatched range of services.
We are always interested and eager to serve you. Like the most impassioned professionals in any industry, we never stop chasing the absolute ideal.
Quality Management consultancy and integration
IT and System Validation (ISPE GAMP 5)
Audit Service Center (third party / shared audit programs)
Project / Program Management
Pharma 2.0 implementation (EBR, Paper less Lab, Data Warehouse)
Network / Infrastructure Qualification
Qualification, Verification, Review services
Special topics like Spreadsheet or ERP validation
GxP compliant development, Document Management Systems, etc.
Deviation management support
Regulatory inspections / audit preparation and escort services
OnLabs is a highly experienced, premier consulting company that specializes in simplifying and streamlining quality management systems and fulfilling regulatory compliance requirements:
Quality Management and Validation Services
Best Practice for GxP compliance
IT Management and Services
Excellent business and solution network
Leading Subject Matter Experts
up-to-date regulatory and technical knowledge
We are supporting pharmaceutical companies to comply with different applicable regulations.
We offer high quality, advanced consultancy and solutions for the healthcare, medical device and pharmaceutical industries.
OnLabs is dedicated to serving the patient, the medical community and the pharmaceutical industry with the best practices of services. We recognize our ethical responsibility to the patients and community.
Our objective is that your IT project gets a Regulatory Compliant Solution right-first-time, in time and in budget, corresponding to your exact needs and expectations. Profit now from our expertise, an established and professional vendor and business network for the following systems and applications. OnLabs has experience on the following solutions including, but not limited to:
OnLabs Experts work with you to look at the organisation holistically in the light of best practices and your existing policies, procedures, processes, and applicable regulations. From that starting point, we will help you plan a risk-based route that lets you take consistent steps to achieving the results you need. Then we help you take those steps, using proven services and methods to gain the benefits of a consistent, value-added approach to compliance.
Quality Management and Validation software solutions
Robust and collaborative Knowledge Management Systems
Web-based Validation and Project Database
Experts integrated into your project teams and compliance programs
Are you determined to kick off a compliance program in order to gain a competitive edge? Our comprehensive package of sector-specific services will enable you to derive long-term benefits and bottom line economic results. Isn't it about time you get morethan SOPs and Forms from your compliance program?
Making compliance requirements understandable and systems ready-for-implementation
Make the audit process faster, easier and with fewer findings
Bullet-proof your IT Compliance projects
Lower operational costs and improve business value
Providing Inspection Readiness
Our passion and participation in industry organizations provide OnLabs Systems the opportunity to learn and contribute to the industry we serve.
ASQ -The American Society for Quality
A professional membership organization dedicated to the achievement of total quality management and to create better workplaces and communities worldwide by advancing learning, quality improvement, and knowledge exchange to improve business results.visit the website
ISA The Instrumentation, Systems, and Automation Society
A nonprofit, educational organization that fosters advancement in the theory, design, manufacture, and use of sensors, instruments, computers, and systems for automation control in a wide variety of applications.visit the website
ISPE International Society for Pharmaceutical Engineering
ISPE, the International Society for Pharmaceutical Engineering, is the world's largest not-for-profit association serving its Members by leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle.visit the website
Manufacturing Enterprise Solutions Association
(MESA) International is a worldwide not-for-profit community of manufacturing companies, information technology hardware and software suppliers, system integrators, consulting service providers, analysts, editors, academics and students. The combined purpose is to improve business results and production operations through optimized application and implementation of information technology and best management practices.visit the website