Survey Results on the Use of Electronic Documentation in Equipment Qualification

Recommendation

23-25 April 2024

Cleaning Validation AND Pre-Course Workshop: Impact of Annex 1 Revision on Cleaning Validation - Live Online Training

Since at least the end of the 80s, equipment qualification has been an official expected standard. In the meantime, electronic documentation systems have been widely used. Nevertheless, pharmaceutical companies often still work with paper, especially in the field of equipment qualification. Even if the entire qualification documentation is provided electronically by the equipment supplier, it is often still printed out. Is this necessary? Could the electronic documentation not be usable by both parties involved (the supplier and the pharmaceutical company)? Would it not be possible to use more qualification documents electronically?

This is something we wanted to find out from you. 14 questions were asked to give an overview of this topic. A total of 69 people took part in the survey. In the following, you will find an extract of the questions asked and their answers. Not all participants have answered all questions, and sometimes several answers were given, so that, in some cases, the percentages add up to more than 100%.

The majority of the 69 participants come from the pharmaceutical industry (over 60%), almost 38% from the active substance producing industry (chemical and biological active substances) but also just over 10% of the participants come from the medical device sector and just under 10% are equipment suppliers.

Almost 50% of the 69 participants come from companies with more than 500 employees, just over 20% of the participants are employed in companies with 100 -500 employees. The remaining participants are divided between companies with 1-50 and 50 - 100 employees.

When asked whether electronic systems are currently used for qualification documentation, almost 28% of the 69 participants answered yes, corresponding to 72% not using electronic documentation in the qualification area.

A whole range of different systems are used, from electronic document management systems to in-house developments. To the question which documents are archived electronically, out of a total of 20 participants, 5 participants answered that they archive all documents electronically, 4 participants archive protocols and reports, 2 participants archive user requirements and protocols and reports. It is interesting to note that almost 42% of 58 participants plan to use an electronic version for qualification documents in the future instead of continuing to use handwritten documents. 48% do not want to switch to the other way round.

Out of 23 participants who would like to purchase an electronic system, 6 participants answered the question of what should be purchased that this has not been decided yet or is currently being evaluated. A clear pattern of responses with regard to one system did not emerge, however.
What do those participants who are planning to purchase an electronic system expect (24 answers in total to this question)? Clearly, a reduction of paper is expected in the majority of cases (6 answers) and thus easier archiving (4 answers). Furthermore, faster processing is expected (4 answers) and greater transparency and traceability (4 answers). 3 participants expect a faster approval procedure of documents, higher security regarding data integrity and also easier handling of the documents.

The question of what challenges are seen in the introduction of an electronic system was answered very differently (20 participants) and was difficult to "cluster". 3 participants were concerned about data integrity, while two participants were concerned about the acceptance of the system itself or its integration into existing (IT) systems, data protection and process changes. Two participants also see the training of the system as a challenge.

When asked if there were any documents that could not be used as electronic versions, 65 participants answered. 80% of them see no restrictions. Restrictions are seen when it comes to signatures (4 participants) and for two participants the leading documentation has to be paper-based.

A total of 39 participants responded to the question of whether there were requirements for supplier documentation. 15 participants answered no, 15 answered yes. Those who answered yes require the following documentation requirements from a supplier:

• Part 11- Compliance at the supplier: 4 participants
• Data integrity requirements: 4 participants (2x ALCOA)
•  Validated system at the supplier: 3 participants

14 participants responded to the opportunity to add still open topics, whereby "clustering" was not possible. But there were interesting individual opinions, e.g. regarding the acceptance of an electronic qualification documentation concerning older colleagues, which was viewed critically. One time, the desire for standardisation was expressed for the entire pharmaceutical industry and one participant was concerned about the question of presenting electronic documents during an inspection ("should the inspector have access to all electronic documents?")

The last question was about whether the participants would share samples via the ECA Academy to improve the systematics of electronic documentation. Of the 61 participants who answered this question, almost 40% would be willing to do so.

Conclusion: The topic of electronic qualification documentation is fascinating! Its use is not widespread yet. However, there are definitely plans to change this in near future. The systems used so far are relatively inconsistent in the companies. The advantages are obvious, in the majority of cases a reduction of paper is expected and with it an easier archiving, in addition to a faster processing and a higher transparency and traceability.

At this year's ECA Launch Conference on 27/28 October 2021 in Berlin, Germany or alternatively online, the final version of the Good Practice Guide Integrated Qualification and Validation will be presented. A chapter on electronic validation documentation will also be addressed.