Archives and record management

As there is a shortage of qualified archivists, it is a secure career and promotion opportunities are good.

Archiving is essentially about managing information – filing it, being able to find it again, and disposing of it when no longer required by the business, law or regulation. That sounds simple, but think about what this means within the pharmaceutical industry. From the time scientists first develop ideas for potential new drugs until those drugs go on sale, every detail of the development process has to be recorded. That information must be ready for easy retrieval, not only at every stage of the research and development process, but until it is withdrawn from sale.

The archiving process

Archiving takes place when a project is finished or work on a chemical compound is complete. The information is stored in a variety of media (paper and electronic records) and reference details, including a trigger date for destruction (if appropriate), are recorded on a database. For legal reasons some types of information have to be stored for years and may be transferred to microfilm. Data on clinical trials, for instance, is retained so that it can be referred to if problems occur later in the drug's lifetime.

Electronic storage is one of the most critical issues for pharmaceutical archiving. Regulatory bodies require information created electronically to be stored electronically, and long term preservation of these records is a key concern. Changing technology can also make it difficult to access old documents, such as those created in the 1980s using WordPerfect.

Regulation and inspection

Archiving departments in pharmaceutical companies are strictly regulated and inspected. Inspectors often challenge the departments to prove their systems are effective, by asking for particular documents, for example, and timing the speed of retrieval. Standards like these are one of the reasons archiving in this field is at the forefront of best practice. The fast pace of development, the volume of information and its scientific and commercial importance also means the technology and facilities are among the most advanced in the world. It's not just a problem for the pharmaceutical industry, but companies in this field are leading the way in the search for solutions. It makes it an exciting time to come in.

Working in archives and records management

There are two routes into archiving. The most common is to gain a postgraduate diploma in Record Management and Archiving. First degrees in English or history were traditionally preferred for this course, but now any degree is acceptable. The other way into archiving is to come in at the lowest level, carrying out routine filing and scanning. You will have ground to gain if you want to become a manager, but some companies offer study leave to gain the diploma and provide courses on subjects like customer relations.

In terms of personal qualities, because archives work on a logical basis you need that characteristic too. You have to be disciplined to keep to the strict guidelines, and customer focused because you're providing a service to the rest of the company. Patience is important, as people will often ask you to find documents without having the details necessary to find them easily. You must also like working in a quiet environment but have the confidence and ability to talk articulately to people at all levels. Scientific knowledge can make it easier to talk to scientists but it's by no means essential.

Roles within archiving and records management

At whatever level you come into archiving, data input and searches will usually be part of your work. Roles and titles differ between pharmaceutical companies but the management positions are, broadly, the same:

• Records Manager – manages workloads, liaises with other departments and handles information reviews and destruction
• Team Leader – heads a team, deals with strategic issues and manages contracts with destruction and microfilm companies
• UK Archives and Records Manager – manages and co-ordinates the work of archives across the country, and is responsible for disaster management and international liaison

The profile of the profession is rising due to the growing recognition by business leaders of the importance of managing records correctly. There have been a number of high profile legal cases (Enron, WorldCom, Morgan Stanley) where inadequate record keeping has led to very large fines . Most archivists in pharmaceutical companies stay in the industry because the salaries, benefits and facilities tend to be better than elsewhere. It's also possible to move into regulatory affairs or information science as the knowledge and skill you gain in archiving is relevant to those areas too.