Compliance Services

Wincere’s pharmaceutical, biotechnology and medical device compliance teams develop the quality and compliance strategies, practices and systems that establish a strong foundation for long-term regulatory compliance. Our focus is on the business and scientific processes and information technology associated with the clinical trial process in drug, medical device, discovery, and development companies.

The Wincere compliance practice focuses on following areas:

• 21 CFR Part 11
• GMP/GLP/GCP validation
• IT infrastructure qualification
• Compliance consulting and auditing

21 CFR Parts 11 

The Food and Drug Administration (FDA) announced its decision to re-examine Part 11 in September 2003, withdrew all previously released Part 11 guidance, and then revised all previous FDA statements related to the Part 11 interpretation.

What does the current FDA guidance mean to pharmaceutical, biotechnology and medical device companies?

Wincere’s Part 11 services interpret the guidance and help to make it a less burdensome approach to you our customers. Our Part 11 services span all functional areas within a pharmaceutical, biotechnology and medical device organization. We can develop a corporate-wide strategy and implement it at a facility level.

Our engagements have taken us through almost all facets of Part 11. 

Some of our specific offerings in respect to Part 11 are:

• Corporate-wide planning strategy
• Interpretation
• Gap Analysis (GA)
• Risk Analysis (RA)
• Remediation (corrective action) planning
• Product capability analysis
• Corporate policies, guidelines standards Training GMP/GLP/GCP validation

GMPs 

Today’s good manufacturing practices (GMPs) for pharmaceutical, biotech, and medical device manufacturing have been around for over 25 years. They are prescriptive and encourage a quality by inspection approach to maintain drug safety, quality and efficacy during manufacturing, packaging and distribution.

Market forces and a wave of modernization at the Food and Drug Administration (FDA) are driving the industry toward quality by design. With their GMPs for the 21st-century initiative, the FDA regulators have raised the bar and challenged the industry to comply with a more scientific approach to quality.

The focus of our services is to ensure that the computer systems in the GxP world are reliable and robust throughout validation. We apply the knowledge base that our experts have created, to design validation methodology and programs, which not only exceed FDA expectations, but align with our clients business needs. 

Some of our specific offerings are:

• Perform Risk Analysis (RA)
• Evaluate technology and vendors
• Develop user requirements, functional requirements, system specifications
• Develop validation plans and project plans
• Perform vendor audits
• Develop software quality assurance plans
• Support development, installation and commissioning
• Implement unit and integrated system testing
• Develop and implement installation, operation and performance qualification protocols
• Develop traceability matrices
• Develop standard operating/departmental procedures
• Site Acceptance Testing (FAT/SAT)

IT infrastructure qualification

Computer systems are based on an infrastructure made up of a data center, servers, client workstations, routers, and protocols. The qualification of this infrastructure is essential to the validation of computer systems. In fact, since the network and the servers sustain validation systems, the infrastructure guarantees reliability, security and continuity.

Moreover, managing the security, the internal and external access, the data management, and the overall configuration of a network and its components can be a daunting task.

We provide a technical quality support in order to set up a quality system in the computer service, or to complement the existing procedures. Our qualified consultants, together with the largest building editors, will help to validate your hardware configurations of IT infrastructure components. 

Our offer includes but is not limited to:

• Revisit design and segmentation of the network into GxP and non-GxP
• Infrastructure qualification plan
• Network qualification (equipment, protocols)
• Data center qualification
• Server qualification
• Operating system qualification
• SOP: Administration PART 11
• Configuration management and change control
• Setting up of an audit track on databases
• Develop systems run books and plans
• Implementation of Disaster Recovery Plan (DRP), backup and assess management following a business continuity plan
• Compliance consulting & auditing
  

FDA and ICH regulations and guidelines: 

Our experienced auditors follow FDA and ICH regulations and guidelines to ensure consistent audits and communication across global trials. They work closely with each client to develop and implement audit plans that utilize and comply with the client’s Standard Operating Procedures (SOP).  

Our offer includes but is not limited to: 

• Preparation of essential document review guidelines
• Investigator site audits to verify the accuracy of the data being submitted to the sponsor and to ensure the site is complying with the protocol, regulations and guidelines
• Preparation of investigators for regulatory authority audit
• Review protocol and Informed Consent Form (ICF) for compliance
• Database and final report audits
• Sponsor/monitor/CRO audits
• Vendor and site audits
• Institutional Review Board/Independent Ethics Committee audits
• Review of key deliverables (protocols, reports, datasets, etc.)