Why small pharmaceutical and biotechnology companies can (and should) acquire an EDMS

For the past two decades most, if not all, documentation supporting the development, registration and marketing of pharmaceutical products has been generated in electronic format. The large companies realized very early the need for some system that would allow the management of these documents and their secure preservation. These tools were described under the acronym of EDMS (electronic document management systems). In the late 90’s the FDA published the legal frame (21 CFR part 11) for the acceptance of electronic records and electronic signatures. During the same period, an electronic communication protocol (the eCTD) based on extensible markup language (xml) was developed in the framework of ICH to allow for electronic transmission of registration dossiers and the exchange of information between sponsor companies and regulatory agencies. Electronic regulatory dossier management required the development of yet another class of tools for the assembly (publishing), transmission and viewing of these dossiers known as eSUB.

Implementing EDMS has proven to be a complex and costly exercise. In the early days only the larger companies could afford the cost of setting up and maintaining a complex network of servers and applications, training their employees and making the transition from paper to electronic records. Each company spent a lot of time, money and internal resources to determine requirements, program the software and plan the repositories structure for document classification amid lengthy discussions between departments and under the suspicious look of worried employees.

Software being what it is, an area of fast evolution, by the time these systems were in place and well understood by everyone, it was time to replace them. Some progress had been made in standardisation but in most cases replacement and most importantly migration proved to be yet another nightmare for the sponsor companies.

In this context, smaller companies were hesitant. Many resolved to wait and outsource their documentation management to CROs especially the publishing and submission part. Others managed as best they could with shared drives and internal rules. Clearly these could not ensure the level of control and security provided by the large professional-grade systems such as Documentum®.

Then something happened. Or rather some things happened. Firstly, cloud computing came into our lives. Cloud computing is different from simple storage in the cloud. It means that software such as those used for EDMS are now managed, updated, validated and maintained centrally by the vendor company and offered as SaaS (Software as a Service) to their clients. No more need for servers, IT personnel, technical administrators and the TCO (total cost of ownership) has decreased dramatically bringing these solutions within reach of even the smallest of companies while maintaining all the advantages previously reserved to the “big guys”.

And that was only the beginning. One of the leading associations of the pharma-ceutical industry, the DIA (Drug Information Association) through their network of professional benevols (which I am proud to be part of) tackled the issue of classification and produced the DIA EDM RM (Electronic Document Management Reference Model) and subsequently the TMF RM (Trial Master File Reference Model) and other branch classifications. These are now widely accepted as the standard in the industry and offered free of charge by all software vendors. The reference models have taken a huge burden off the shoulders of pharmaceutical companies saving them months of tedious work and ensuring consistency, internally but also with other companies in case of exchange of products.

Still, small companies are hesitant to cross the Rubicon. EDMS remains a cost that is not immediately perceived as essential (until the first audit that is) and when it is, the knowledge is missing to allow for selecting the right vendor and the right tools. What are the needs of the company? What are the essential functions the software must cover? Are we taking risks by moving our key documents in a new system and moreover into the cloud? There was a clear need for one additional innovation to unlock the way to EDMS for small companies: A packaged protocol for selecting the appropriate software that included a standard set of user requirements and a simple notation grid.

The DIA came to the rescue once more. Through a large collaborative effort, we have created Pocket EDMS, a standardised protocol and user requirements specification validated by a large number of professional users and accepted by the majority of software vendors as a good basis for selection. Everything an EDMS needs to do to fulfil its role is described in the simplest and more concise possible way. Dedicated sections describe specific requirements for quality documents (and soon also for trial master files management). And all for free, created by the industry and for the industry.

Lower flexible operational costs + no need for IT infrastructure + free classification models + free implementation guide = EDMS for any company is now possible.

Check the Pocket EDMS webpage and feel free to use the material posted, contact any of the participating vendors or go to the discussion forum and ask any questions you might have.


Call for the Pocket EDMS Steering Committee

A Steering Committee grouping representatives from all interested areas is being put together. We are still looking for one representative from a biotech company to officially launch the committee. If you are interested, please contact us at pocketedms@maiaconsulting.eu

Extending Pocket EDMS

The Pocket EDMS management team is now working with the Scientific Archivist Group (SAG) Good Clinical Practice (GCP) special interest DIA group to finalise and incorporate a set of requirements specifically targeted at eTMF management tools. This will allow Pocket EDMS to cover all aspects of the clinical documentation management.

A how-not-to story


My First EDMS


I’m not bitter. Not anymore. Not much anyway. Hardly at all.

When I arrived at a new company, I asked to sign all the checks for the first few months because, well, that’s just what I do. So, the first check that came through for the EDMS caught my eye since it was for twenty thousand dollars or so. For a small company, that was a lot of money. When a second check came through for about the same amount a few weeks later, I started asking a lot more questions. Then I picked up the phone and called the CEO.

“Are you aware that we’re on track to spend a quarter of a million dollars on a document management system?” I asked him.

“What’s a document management system?” he responded.

I asked to tour the computer room to see where all this money was going. In the middle of the room, rising from the floor like a gleaming black monolith, was the stack of shiny HP servers that housed the document management system, its database, and its backup. The expensive monster smirked at me. Scattered against the wall, on old carts or on the floor, were some junky-looking Compaq servers that held our clinical data, our research and engineering studies, our accounting and inventory systems, and all our personnel records. By now, the IT guys were hopping around me.

“I know how this looks. This was not my recommendation. I felt that we could make this investment in a different way. I…” the external IT consultant was CYA-ing super fast.

The technical guy was more pragmatic. “Can I use these? Because the EDMS guys won’t let me. And I want to.”

“I gotta talk to some people. Is all this stuff backed up?” I asked.

“Yep, it’s all backed up every night, and there’s a backup power supply,” they told me proudly.

I backed out the door and gave the monster a dirty look.

The next day we were scheduled to have an offsite strategic planning session, and the senior staff was ordered to leave their cellphones behind so there would be no interruptions.

“But how can I reach you if I need to talk to you?” my IT manager, Mike, asked.

“You can’t, but you won’t need to,” I said rashly.

In the middle of the morning session, my cell phone (hidden in my bag) rang. Flustered, I saw that it was Mike and hung up. It rang again. Mike. I turned it off. Go away.

A few minutes later, the Engineering VP’s cell phone (hidden in his pocket) rang. He answered surreptitiously and looked at me. I shook my head. The CEO paused in his presentation and looked at us sternly over his glasses. I shook my head more vigorously. The Engineering VP spoke quietly into the phone again and then handed it across the table to me.

“He’s making me hand this to you,” he whispered. It was Mike.

“What,” I said into the phone.

“The emergency power supply has had a catastrophic failure,” he said excitedly.

“What does that mean?” I asked.

“It kind of—blew up,” he said.

I got up and walked out of the room. I could feel the CEO’s eyes following me.

“Say that again?” I said disbelievingly.

Mike explained that the outside technician had been on site changing batteries, and when he tested the system, it suffered a “catastrophic failure.”

“You mean the technician was there when this happened?” I reiterated dumbfounded.

One of the managers appeared in the door. He had been sent to retrieve me.

“You have to come back to the meeting,” he said nervously.

“There’s been a catastrophic failure,” I told him. He went away and didn’t come back.

“What’s it going to take to fix it?” I asked into the phone.

You guessed it. Money, lots and lots of money. Money that we didn’t have because all our IT money had been spent on, you know, the EDMS.

Nine months later, after endless meetings, explanations, presentations, arguments, and verbal fistfights, the backup power supply was fixed, and the monster now housed all our corporate information, including the EDMS shell (still not a single document was in it), and the Compaq computers had been recommissioned for less critical data processing tasks.

But more madness was around the corner.

“Now we have to validate the system,” the EDMS guys told me. And someone hired a validation consultant.
“This guy’s an expert,” they said as I dolefully watched his shiny sports car pull into the lot. The name of his company was abbreviated on his vanity license plate. The bills started rolling in. I was almost stuttering by the time I showed up at LSIT’s quarterly meeting, an organization committed to standardizing Good Informatics Practices for life science companies.

“We just added a piece of equipment, and the validation cost more than the hardware,” I said, shaking my head, now more shocked than mad. They patted me on the back and made comforting noises, but this problem was not going to get solved in the short term.

Validation took months but aged me years. It occurred to me that EDMS was an anagram of “meds.” We eventually just stopped and asked the validation consultant to go away.

Then the “Training” phase began. I discovered that I am not a “process” person. I am a “Can we actually start using this darn thing?” person. And the meetings went on and on. I remember someone pulling up a screen full of little words and fields and beginning to discuss it at length. I think the point was to select the fields that you wanted to require each user to fill in to record the metadata of the document before it could be stored on the system. There must have been fifty fields on that page. I felt physically repulsed by this screen, simultaneously bored and horrified. It dawned on me that very few people in the company would have the patience to use this system, and that I myself would never put anything in there.

When the committee began to roll out the system, the EDMS guys wanted to mandate its usage for all company departments.

“We’re not going to use it in Administration,” I said firmly.

“But we’ve spent so much money on it,” the CEO said.

“That’s true. But we don’t need both a calamity and a disaster,” I groused.

The company eventually got the document management system semi-functional. It was expensive, painful, and destructive. The money and effort would have been more productively spent developing anti-viral compounds, because that’s what we were good at. I learned that lesson the hard way. When I joined my next company, the concept of an on-line DMS that required no additional hardware was very appealing. That image of the black monolith was still easy to conjure up, particularly its mocking face and associated checks. But that’s in the past. Now I can look back on it and laugh. Mostly.

Copyright © 2011 Jennifer K. Crittenden

Published in the Mission3 Newsletter-November 22, 2011