Electronic Data Archiving For Standards & Regulation

It is generally accepted that there are no commercial “off-the shelf” solutions that can comprehensively meet all the demands of the regulated life science sector, and meet security and confidentially criteria over a number of software and technology platform upgrades and changes. Although such commercial solutions are in development, it is unlikely that future archiving needs can be fully addressed using “off-the-shelf” offerings, says the ISPE.

Its new GAMP Good Practice Guide: Electronic Data Archiving seeks to provide a rational and scaleable approach to electronic data archiving through the development of an archiving strategy. The implementation of this strategy should help organizations achieve and maintain regulatory compliance, and to effectively manage electronic records over the long term.

The Guide addresses management, planning, development, operational, and compliance issues. Current GxP regulations related to archiving have been taken into account in developing this Guide.

Specifically, this Guide:

Provides an introduction to the complex subject of electronic data archiving, recognizing the differences from the traditional paper archive,

Provides a process for creating and implementing an archiving strategy,

Highlights considerations in determining an archiving strategy, at an organizational, technical, and regulatory level, and

Identifies those aspects of technology that have an impact on the selection of an archive solution, which are independent of specific technical solutions.

This Guide covers a number of concepts, issues, and practices as they apply to the complex and developing subject of electronic data archiving, including the fundamental role of the Archiving Strategy document and aids in the electronic records work.

Pharma Asia: What are the electronic data archiving issues in Asia?
Olsson: Pharmaceutical companies are required by regulations to keep certain records for a long period of time. Examples of records include GLP records, clinical trial studies and blood distribution records. Up until recently, these records would have been archived as paper records for safe storage, with paper archives having stood the test of time.

Things have changed in recent years, however. Many, if not most, of these records are today generated electronically using various computer systems. Some records are complex composite records that do not lend themselves to printing. We are facing a data avalanche with ever increasing amount of records being created and that will potentially need to be stored for a long time.

To continue using paper archives would mean increased costs for storage and managing the archives, loss of information such as electronic metadata, and loss of ability to perform efficient data mining using electronic search tools. There is only one conclusion to this: electronic records should be archived electronically.

Whilst using an electronic archive is both feasible and reasonably straightforward, these archives have not stood the test of time. Computer systems in terms of hardware, software, peripherals, file formats, languages and storage media have all evolved rapidly and will continue to do so. However, backwards and forwards compatibility has not always been good. As computer systems become obsolete, it is getting increasingly more and more difficult to access and understand the previously stored data. This is an uncomfortable fact when the regulatory is demanding records as old as 30 years ago to be fully accessible.

These issues are global and affect all pharmaceutical companies wherever in the world they are operating.

Pharma Asia: What is the remedy?
Olsson: One way of addressing the problem with backwards and forwards compatibility is the route of standardisation. An example is the use of Extensible Mark-up Language (XML) and adopting various archiving standards. But who can say if these will prove to be stable? Innovation usually challenges standards, which do evolve over time. Computer hardware and software are also bound to continue to develop rapidly.

Pharma Asia: How instrumental is the guide to the professionals in Asia?
Olsson: The guide is not purporting to have the answer to all the questions, but its aim is two-fold. Firstly, by outlining good practices, it starts to reduce the regulatory risks. The guide attempts to set a standard that when followed should attract minimal regulatory adverse comments. In essence, by following the guide, the pharmaceutical organisation can use electronic data archiving despite the inherent unknowns about the longevity of the used commercial solutions.

Secondly, electronic data archiving is a complex subject. Whilst there is an enormous amount of information available, the guide is putting this information into context of meeting pharmaceutical regulatory demands. The guide acts as an introduction to a complex subject. Any professional faced with the subject of EDA should make this guide his or her first port of call.

The main GAMP v4 guide contains very little on electronic archiving, so the new guide clearly fills a void. It is also very topical, and it is hoped for that this guide can stimulate industry-wide discussions on this very important subject.

The guide is not aligned to any particular region or regulation. Whilst many of the regulatory citations are taken from the US or EU, the guide is universally applicable to Asia. Asia is facing exactly the same problems with regard to electronic data archiving as the rest of the world. The pharmaceutical industry is a world-wide industry working to similar rules and regulations globally.