Cloud Computing: Audit / Remote audit of a Cloud Service Provider
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 11: How many days must be planned for the audit of a CSP? Is it also possible to carry out a remote audit?
Cloud Computing: Which Persons should participate in the Audit of a CSP and which Topics should be addressed?
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 10: Which persons (functions) should participate in the audit of a CSP and which topics should (must) be addressed?
FDA's Q&A Paper on Electronic Systems & Electronic Data in Clinical Trials
The FDA issued a new version of the draft guidance on electronic systems in clinical Investigations. The document provides additional recommendations on the risk-based approach to validation of electronic systems.
Cloud Computing: Multi-tenant provisions of SAAS and Change Control
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 9: The multi-tenant provision of SAAS is accompanied by a source code basis for all customers. This implies that all customers must have the same software version irrespective of whether or not a customer accepts a certain change. Is this compatible with GxP?
Cloud Computing: Which contents must be covered by the service provider's change control?
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 8: Which contents must be covered by the service provider's change control and in which way must the contract giver be integrated into this system?
In April 2023, the Data Integrity Task Force of the APIC Quality Group, which is a sector group of the European Chemical Industry Council (CEFIC), published the document "Data Integrity Frequently Asked Questions (FAQ)" on its website. This document providees numerous questions and answers on the topic data integrity that were submitted to the Task Force by the pharmaceutical industry.
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++.
Cloud Computing: QMS of the Cloud Service Provider (CSP)
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 7: Can we assume that if there is an appropriate QMS implemented and if the CSP acts in compliance with this QMS (as a result of an audit), the service provided functions in accordance with the specification and the operational controls are carried as described in the CSP's internal procedures?
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?