GXP Systems

Compliance Our people help companies keep their systems in a state of validated compliance.

Compliance

Global businesses in life science industries turn to Stericycle GxP solutions to achieve compliance within an increasingly complex regulatory environment. With a proven track record on global compliance projects, our people help companies keep their systems in a state of validated compliance without losing operational flexibility and productivity. In fact, Stericycle GxP Solutions' teams are regularly recognized by our customers as having delivered on time, within budget and with energy and commitment.

Our successes from continuing audits by worldwide regulatory bodies are a testament to the quality and relevance of our approach for compliance for every client. Our compliance services meet your specific needs due to our unique approach.

Comprehensive Risk Assessment/Analysis
  • PFMEAs, Root cause analysi
  • Risk index calculations
  • Functional risk assessment
  • Site-applicable risk assessment
Holistic Project Approach
  • Based on global industry regulations such as FDA, EMA, IMB
  • Full gap analysis
  • Protocols, work instructions, and standard operating procedures development
  • Effective knowledge transfer
  • On-going managed services
Proven Project Life Cycle Expertise
  • Extensive library and repository of industry-related documents, processes and guidelines
  • Long history of experience in the life sciences sector
  • Basis for continuous compliance throughout project phase(s) and beyond
  • Expectation of successful future audits and compliance inspections
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Periodic Review

Stericycle GxP Solutions carries out multi-site reviews of client documentation, procedures, records and performance to ensure that your facilities, equipment and systems continue to be fit for purpose and meet safety regulatory compliance requirements. Through years of experience in the life sciences industry,we can implement a scalable Periodic Review program for your organization.

Risk Assessment

GxP Systems brings its scientific approach to assessing and managing risk to our clients' organizations. Using tools such as (P)FMEA and RPN methodology we take our clients along the path of organizing the appropriate information to support risk mitigation decisions.

Consent Decree

Through our extensive pool of life science consultants, GxP Systems project manages and provides SMEs for the entire range of remediation activities to ensure compliance within applicable regulatory standards

Procedure Development

Our team of experienced life science consultants will help you with the development and design of compliant processes and the subsequent documentation.

Interested in our solutions?

Contact us now.