07.11.2011

SAP’s Berndt Stürznickel on Chemical Compliance

Regulations - Compliance in the chemical industry has gained a tremendous amount of significance over the last several years. Reach in Europe and the Toxic Substances Control Act in the U.S. are not the only regulations setting the standards for compliance; many other countries are coming up with regulations of their own as well. Also, gaps in supply-chain communication can sometimes lead to a supplier being inadvertently non-compliant.
more19.10.2011

Non-compliance is on the Rise

Steady Increase - All who follow industry trends will have noticed an increase in regulatory actions related to non-compliance issues. We can see this in the increased issuance of inspectional observations - or 483s - by the U.S. Food and Drug Administration (U.S. FDA) and by the withdrawal of certificates of suitability (CEP) certifications by the European Directorate for the Quality of Medicines and Healthcare (EDQM). more01.08.2011

SAP’s Martin Hill on the Importance of Chemical Compliance

Hand In Hand - Compliance with regulations implemented to protect humans and the environment has been a top priority for chemical companies in Europe in the recent years. On the other hand, sustainability is gaining in importance in all industries.

Brandi Schuster caught up with Prof. Dr. Martin Hill, vice president of sustainability EMEA at SAP, to talk about the correlation of the two topics. Hill has many years of experience in chemical compliance consultancy and sustainability. more22.07.2010

Qumas –Streamlining Compliance Across Life Sciences

QUMAS has over 15 years experience in highly regulated industries, providing world class compliance solutions to over 250 customer deployments (some with 120,000+ users), including seven of the top 10 pharmaceuticals, four of the top ten biotechs, and five of the top ten medical device companies, as well as leading financial services firms.
The company's R&D headquarters are located in Cork, Ireland, with European sales offices in Dublin and Geneva. The company also has a US headquarters in New Jersey and USA sales offices in New York and Boston. more