GMP News - Computer Validation

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?

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.

On 8 April 2022, the FDA published a new draft guidance "Cybersecurity in Medical Devices..."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 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.

Change control is mandatory to maintain the validated state also for computerised systems and is subject to inspections. What are the regulatory requirements and what is the inspection practice?

The Pharmaceutical Inspection Co-operation Scheme (PIC/S), as the international association of pharmaceutical inspectors, published the long-awaited guidance document on data integrity on July 1, 2021. Read more about the contents of the document PI 041 "Good Practices for Data Management and Data Integrity in regulated GMP/GDP Environments".

The issue of data integrity generates a multitude of questions. Current questions are addressed in a loose sequence of News. Question 10: What regulations must be in place to ensure that in case of business discontinuation (insolvency) of a cloud service provider, the data is completely returned to the client?