Compliance

WHITE PAPERS AND CASE STUDIES

• Software Automation In The Blood And Biologics Industry

  Explore the different categories of solutions available to improve process efficiencies as well as the needs and wants that they address.

• Demanding More From AI Governance In Drug Safety

  Embedding AI governance into your an AI-enabled safety system from the start empowers trust and streamlines the path toward success; it is merely the evolution of good data and risk governance.

• GFI Case Study: Montclair Board of Education Montclair Public School District, is recognized by the United States Department of Education as one of the six best magnet school districts in the country with a group of schools falling under this umbrella name that accept students ranging from ages 5–16. Over 2,000 employees using email extensively and with...
• Serialization And Traceability Compliance In Pharma And Med Device

  Explore the role of traceability and serialization and the benefits they offer beyond compliance. Further, gain perspective on how to approach UDI implementation and choose an appropriate solution.

• Case Study: Commercial Metals Company Centralizes AP Processes And Save 55,000 A Year With ImageSilo® When the Director of Shared Services at Commercial Metals Company (CMC) was asked to centralize the accounts payable processes of 40 metal recycling yards scattered across the country, he quickly realized that paper documents were the roots of his AP problems at the yards. By Digitech Systems, Inc.
• 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.

• LP Execution: Train, Test, Comply An LP (loss prevention) training, testing, and compliance monitoring solution helped $2.2 billion Pep Boys reduce shrink by as much as 10% and cut DC accidents by 50%. Used with permission from Integrated Solutions For Retailers magazine
• Safeguarding The Viability Of Pharmaceutical Samples Within 42 Hours

  The distribution of critical cell samples requires an agile strategy with contingency planning and regulatory expertise to ensure seamless delivery on-time and within specifications.

• 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
• Safety First In The Field!

  Accidents happen. According to the Occupational Safety and Health Agency (OSHA), they usually happen because companies, or their employees violate safety standards in ten key areas.

• Adopting Label Change Best Practice To Promote Clarity And Compliance

  Globalized clinical trials are quickly becoming a pre-requisite for success. Read Almac’s latest case study to learn how one sponsor was able to extend its trial into new countries without risking labelling non-compliance, which enabled them to continue on their mission to improve the health outcomes for millions of patients.

• Set Up And Qualify GMP Laboratories

  See how a GMP microbiology lab was established and qualified in Ireland, providing expertise, staffing, training, and project management to ensure compliant operations and client success.