Precision

5 STEPS IN CHANGE MANAGEMENT change management

5 STEPS IN CHANGE MANAGEMENT

Change management is the systematic approach to the transition or transformation of an organization’s goals, processes or technologies to ensure effective and successful implementation, monitor pre- and post- change activities, and help people within the organization to adapt to the new standards. Organizational change can be either adaptive or transformational. A common use of change […]

COMPUTER SYSTEM VALIDATION (CSV) validation

COMPUTER SYSTEM VALIDATION (CSV)

Computer system validation (CSV), also known as software validation, is how companies regulate their softwares or systems to ensure that they are performing the way they are supposed to work. The FDA defines software validation as, “Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and […]

BEST PRACTICES IN DATA COMPLIANCE STRATEGIES data compliance

BEST PRACTICES IN DATA COMPLIANCE STRATEGIES

With inncreasing regulatory mandates, intense pressure on pricing and non-stop technological advancements, data compliance modernization is a must for successful life sciences and healthcare organizations. Data compliance seeks to regulate how organizations store, access, and use customer data as well as how data is deleted. Effectively managing data is crucial in protecting an organization from […]

A Guide To a GMP Audit

A Guide To a GMP Audit

A Basic GMP Audit Guide The Food and Drug administration sets strict industry standards to protect and advance public health by helping to safely and effectively speed innovations and ensuring the safety, efficacy, and security of medication, biological products and medical devices. Organizations are responsible for meeting these standards and passing the Good Manufacturing Practice […]

Medical Device Development: A Webinar Series

Medical Device Development: A Webinar Series

View one or all of the 4-part med device development webinar series presented by Don DeLauder and hosted by Maria “Cristina” Muise, MBA, Ph.D., MBA, Ph.D. About the Presenter The webinars are presented by Don DeLauder. Mr. DeLauder is an expert in medical device development with over 25 years of experience in the field. He also has 14 […]

EU MDR Transition Tasks EU MDR

EU MDR Transition Tasks

The tough part for the medical device industry is that this landscape of regulations is constantly changing. The European Union’s Medical Device Regulations (EU MDR) came into effect on 26 May 2021 after a three-year transition period, is no exception. The EU MDR (formally, EU MDR 2017/745) replaced the EU’s Medical Device Directive (93/42/EEC) and the […]

DATA MIGRATION GUIDANCE data migration

DATA MIGRATION GUIDANCE

Data migration is the transfer of data between different types of storage system, databases or file formats which could involve data mapping and re-formatting. This should not be mixed up with data integration which is the process of combining data from multiple sources into a single dataset. It is commonly used when an organization needs […]