Compliance

WHITE PAPERS AND CASE STUDIES

• X-Ray Inspection For Supplement Safety

  Wellington Foods ensures dietary supplement safety using METTLER TOLEDO’s X37 X-ray system, which detects contaminants, and meets regulatory standards with high-speed, precise inspection technology.

• How Social Technologies Are Creating A New Paradigm For Addressing Business Objectives

  This case study investigates how Within3 supported a culture of innovation by introducing three pharmaceutical companies to secure, regulatory-compliant virtual advisory boards. By Within3

• The Importance Of Quality In Raw Material Selection

  Learn how to select high-quality raw materials for cell-based manufacturing in this exploration of the criticality of raw materials, from preclinical development to commercialization. 

• Electronic Informed Consent: Considerations For Implementation In Clinical Trials

  In an era where data acquisition (eg. ePRO), capture (EDC) and storage (eTMF) are done electronically, it is the logical consequence to do the same for the informed consent process as all the advantages of the electronic modality equally apply to this process.

• Supporting the Pharmaceutical Industry with 21 CFR Part 11 Compliance Readiness The purpose of this document is to describe how PANalytical systems support system owners meeting the requirements of the 21 CFR Part 11 regulations issued by the United States’ FDA. Submitted by PANalytical
• Developing An Organizational Roadmap For Post Authorization Safety Studies

  Delve into this case study to find out how a company found a partner to help them analyze the current state of their pharmacovigilance systems, identify opportunities for improvement, and implement industry best practices and standards.

• Medical Device Manufacturer Implements A Next-Gen MES

  A medical device manufacturer raced to launch a new product in a greenfield facility to overcome tight timelines and compliance challenges by replacing paper SOPs with a dynamic digital solution.

• Sprint Helps Make Just About Any Place A Workplace

  Driving down costs to remain competitive can be a tough challenge for transportation companies, especially in the face of increased fuel and insurance costs. At the same time, customer expectations are rising.

• California agencies find private staffing effective If you took a straw poll among public agencies, chances are you would find that a large percentage of them are now using private staffing...
• USP Acceptable TOC Levels For Pharmaceutical Water: How To Achieve Them? Meeting the regulations and validation rules is an important task for the pharmaceutical industry. In order to be compliant with the regulations and meet the required quality and safety standards, the Pharmaceutical industry must develop economical and competitive production and cleaning methods, which in turn will help the industry develop appropriate operational methods. Submitted by Shimadzu Scientific Instruments
• New EH&E White Paper Evaluates Web-based Environmental Health & Safety Training For Laboratory Applications A new free white paper entitled “The Role of Web-based Health and Safety Training in Laboratory Facilities,” is available to help companies, institutions, and universities evaluate the efficacy of using web-based environmental health and safety (EH&S) training to meet their compliance requirements
• Data Integrity - Understanding And Becoming Compliant With GMP FDA Regulations

  Data integrity means data (such as from personnel or environmental monitoring) that is accurate, complete and repeatable, which in turn ensures the product's quality and public safety. In recent years, infractions relating to data integrity have been noted in several Food and Drug Administration (FDA) warning letters, but it is not a new concept. Understanding recent standards, guides and regulations pertaining to data integrity is essential to becoming compliant.