Good laboratory practice requires that electronic records are kept, and that information can easily be accessed.
The pharmaceutical industry is highly regulated. An important aspect of this regulation is the storage of samples and records, ensuring that all information is readily available. In pharmaceutical laboratories data comes from computer imaging, robotic screening and analysis, and of course from the many experiments carried out by scientists and the reports they produce.
Archiving is also vitally important within clinical trials, which must be highly documented, and all information stored long-term. These methods of maintaining documents and chemical and biological samples is therefore an essential part of the research and development of new medicines.
Find out more about the different forms of archiving:
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must be ready for easy retrieval, not only at every stage of the research and development process, but until it is withdrawn from sale.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.
DNA, viruses, microbial organisms, insect and mammalian cells - all the samples that make up a company's biological resource are protected, stored and catalogued by biological archiving.
Newly produced recombinant cells come from scientists who've identified a receptor protein code in DNA that can be added to a cell to over produce that protein. These cells are valuable company assets and, to protect them, they are refrigerated or stored cryogenically (sometimes for decades) until they're needed to test target compounds.
The role of a biological archivist
Archivists receive and note the details of cells deposited in the archive, and retrieve and organise the delivery of samples requested from the archive's database. They provide training and advice on how to use the database, and coach and train business partners in the growth and handling of the biologicals stored in the archive. An archivist will also lead on developing best practice methods for use within the company. Biosafety is an important consideration, particularly when biological samples are transported and shipped internationally.
Scientifically and commercially, the work is vitally important because the archivists are looking after cells and other biologicals that could help identify and produce future drugs. From a more personal angle, the archivists are also responsible for years of scientists' work.
Automation has taken over a great many of the mundane archiving, retrieving and sampling tasks and speeded the drug development process, but there's still plenty of scope for new ideas to improve storage and processing. Creativity is highly valued and archivists who make a difference to working practices are usually promoted fast.
Working in biological archiving
For graduates in biology or a closely related discipline, there's a clear career path from Associate Scientist to Scientist to Senior Scientist to Investigator. Archivists don't tend to stray from this, or change companies often, although it's fairly easy to do so.
Looking after cell cultures appeals to biologists who want to develop their practical and theoretical knowledge – indeed, many archivists become quite attached to their cells! You also need to enjoy working individually and collaboratively, because you'll be doing both. As you're promoted, you'll spend more time in meetings and less in the lab, but that shouldn't be a surprise.
Chemical compound archiving
A career in chemical compound archiving can give you a real sense of ownership and wide ranging influence.
If you've ever wondered what happens to all the compounds created in the early stages of drug development, you have the answer here. Compounds are archived from their initial registration and details of the scientists who worked on them, and the processes they went through, are carefully recorded according to strict industry regulations. Given the breadth of research, the fast pace of development and the length of time for which samples are stored (40 years isn't exceptional), this is a massive logistical exercise.
Highly sophisticated technology
The technology used to archive and retrieve the compounds is highly sophisticated and developing all the time. Current systems can typically bar code some 20,000 samples a day and storage systems are often capable of holding up to 6,000,000 chemical solids/solutions. Archivists have to ensure that the history of each sample is tracked and its integrity is maintained, so that it can be retrieved in any format, at any time, for further research, processing or inspection. It's vitally important work because, at any stage, these compounds could be used to achieve breakthroughs that could make a real difference to a company's success and patients' lives.
Working in chemical compound archiving
As this is a fast changing field, one of the most important requirements for anyone joining it is the ability to keep pace with progress. A degree in chemistry, biology or a related field should mean you're interested in the science and have the basic knowledge needed, but you must be just as keen to develop your understanding of automation and technology.
The way compounds are labelled, stored and retrieved is becoming increasingly advanced, so you'll need to take full advantage of the ongoing training offered in-house and by system suppliers. You'll be encouraged to put forward new ideas and take greater responsibility quickly.
Last modified: 20 September 2023
Last reviewed: 20 September 2023