Final GCP Guideline on Computerized Systems and Data Integrity
The final EMA Guideline on computerised systems and data integrity in clinical trials has now been published. Amongst others, the new document requires procedures to be in place for risk-based trial specific Audit Trail Reviews. In addition, a new expression is defined: ALCOA++.
At the end of July 2022 ISPE published an updated version of the widely accepted GAMP®5 guidance on 'A Risk-Based Approach to Compliant GxP Computerised Systems'. Read a first short review about the content of the revised version here.
Cloud Computing: Common Certifications (e.g. ISO 27000 ff) and their Role in GxP
Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 6: Are common certifications (e.g., 27000ff) reliable evidence that a cloud service provider is suitable, or what requirements must a certification fulfill in order for it to play a role in the suitability of a CSP?
Cloud Computing: Legal basis for cloud solution in a GxP environment
Financial and organizational advantages also speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas: Question 5: The AMWHV (Arzneimittel- und Wirkstoff-Herstellungs-Verordnung) requires that all data according to the manufacturer's authorization reside on the premises. Is then a cloud solution possible at all?
Cloud Computing: Are SaaS closed systems per 21 CFR Part 11?
Financial and organizational advantages also speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas: Question 4: Are SaaS closed systems per 21 CFR Part 11?
Cloud Computing: Reasons for choosing the particular Cloud Model?
Financial and organizational advantages also speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 3: What are the reasons for choosing the particular cloud model (private cloud, community cloud, public cloud)?
Cloud Computing: Cloud Models in the GxP environment
Financial and organizational advantages also speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 2: What cloud models are there and where do they have applications in the GxP environment?
Revision of the EU GMP Guide Annex 11 "Computerised Systems" - Presentation of Concept Paper
The current EU GMP Annex 11 "Computerised Systems" was published in 2011. Due to new technological and regulatory developments, a forthcoming revision of Annex 11 has been discussed for some time. On 16 November 2022, the EMA published a concept paper for public comment. Which points are to be revised?
Cloud Computing: What is the meaning of Iaas / PaaS / SaaS / XaaS?
Financial and organizational advantages also speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 1: What is the meaning of IaaS / PaaS / SaaS / XaaS?
Data Integrity Problems as Main Topic of an FDA Warning Letter
Data integrity is still one of the major topics in FDA inspections. Missing controls to ensure the integrity of electronic data as well as inadequate access controls were some of the reasons why a Warning Letter to American company Vi-Jon was issued.
At the end of July 2022, the GAMP organization has published the 2nd Edition of GAMP® 5. What are the main changes and developments compared to the previous version, which has been available since 2008?
New FDA Draft Guidance "Cybersecurity in Medical Devices"
On 8 April 2022, the FDA published a new draft guidance "Cybersecurity in Medical Devices..." to replace the previous guidance from 2014. Why did the FDA publish this draft?
The FDA provides recommendations for sponsors, investigators, and other interested parties on the use of digital health technology for remote data acquisition in clinical trials. What is required regarding software validation and electronic documents?
The validation of computer-based systems is a regular part in GMP inspections. In this context, the IT infrastructure has also become an important topic. Read more about the regulatory requirements and deficiencies in inspection practice.
The "OECD SERIES ON PRINCIPLES OF GOOD LABORATORY PRACTICE AND COMPLIANCE MONITORING" document No. 22 is a comprehensive, well-written, fluently readable guide to data integrity in the Good Laboratory Practice area.