ISPE offers e-archiving advice

The new good practice guide on electronic data archiving is intended as a supplement to the main good automated manufacturing practice (GAMP) guide, and offers a "rational and scaleable​" approach for electronic archiving activities. In an age where paperless record keeping is becoming a reality, establishing a method by which necessary records can be efficiently stored and accessed electronically is a key task in many industries. A highly regulated industry such as pharmaceuticals requires a reliable and effective way of archiving, which will also help firms achieve and maintain regulatory compliance, according to ISPE. The organization claims that in the absence of a comprehensive 'off-the-shelf' solution that can meet the demands of the life sciences sector and its associated security and confidentiality conditions, there was a clear need for a guide that could help companies address the difficult question of electronic archiving. Despite the fact that regulators demand that firms keep detailed electronic records, technology is moving on so quickly that there is no guarantee that companies will necessarily be able to read such files in several decades' time when technological advances have made today's electronic record-keeping techniques obsolete. This leaves companies in a real quandary - printing paper records may ensure that documents are readable in the future, but it would be highly impractical to print out every single record. Electronic records would solve this practicality issue, but come with the inherent problem that one day the files may simply not be readable. The new ISPE guide aims to open the pharmaceutical industry's eyes to this issue, so it can move ahead aware of the potential problem and prevent nasty surprises in years to come. "It's a very complex subject, especially as electronic archiving is the only economic approach for companies,"​ Per Olsson, guide editor and project team leader, explained to US-PharmaTechnologist.com. "This is a good practice guide with common sense advice…we want to open eyes and get companies to plan ahead, perhaps converting to other file formats and realising that they could lose some data." ​ The guide provides an archiving strategy for companies, addressing management, planning, development, operational and compliance issues. "The main GAMP guide has very little on archiving, only a few pages, so that was another driving force behind the decision to write the guide,"​ said Olsson. There is a vast amount of information on the world-wide-web that considers the issue of electronic archiving and the future problems associated with it, but Olsson says that this new guide published under the ISPE banner provides a good starting point for companies to make them "aware of potential stumbling blocks​" in the future. Olsson hopes that the new publication, the first of its kind in the ISPE library, will stimulate discussion in the industry, and be due for review and renewal in just a few years. The ISPE GAMP Good Practice Guide: Electronic Data Archiving​ is available to ISPE members for $145 and non-members for $215. More information and details on how to purchase the guide can be found here​.