Line of Business
On The Record
What the financial sector now must deal with in terms of regulatory compliance and record-keeping, life sciences and pharma have had to practice for decades.
8/23/2005 9:31:48 AM By: Adam Pletsch
The pharmaceutical and life sciences industries, for example, have seen their regulations grow steadily over the past four decades. In fact, this is where document management originated, in requirements to address some of their most basic regulatory needs.
Every industry has its own set of regulations, and each varies by country. The FDA, the Health Protection Branch in Canada and many other agencies around the world have built up rules. They don't always play nice together. In the health care industry, being asked to provide your birthday to get your prescription filled at the Walgreen's Pharmacy in New York would be illegal in Paris.
So how do firms like Pfizer, Roche and Aventis handle the multitude of compliance requirements?
With enterprise content management (ECM) tools from vendors such as Documentum and Waterloo, Ont.'s Open Text.
Documentum, of Hopkinton, Mass., is the heavyweight in life sciences. According to Tamara Alairys, Accenture's Global ACT — Information Management, North America practice lead, it has been around a lot longer than Open Text, typically handles bigger clients and holds 75 or 80 per cent of the market. But Open Text has become popular with more mid-sized companies, and the word on its product, Livelink, is positive, she says.
""We are a more recent entrant in the life sciences area,"" says Martin Sumner-Smith, vice-president, life sciences solutions, at Open Text. ""Obviously we compete with Documentum in many other sectors. And we are rapidly growing.""
Regulations for this sector fall under what are called good practices: good manufacturing practices, good clinical practices and good laboratory practices.
The pharmaceutical industry, for example, invests billions of dollars in the development of drugs, which, individually, can each take up to 10 or 15 years. It's necessary that the process be very well understood and controlled. As such, documentation is key.
This includes documents that describe what should be done, such as standard operating procedures, and documents that record what has been done. If a regulator comes calling, companies must be able to demonstrate that they are in control of this information.
Broadly speaking, the destinations of documents are twofold. They may have to be maintained onsite for inspection, as in the case of standard operating procedures or manufacturing batch records. Or the documents are required to be submitted directly to the regulatory authorities for their review, as when seeking permission to conduct a clinical trial or ultimately market a drug. Firms must have implicit trust in the software that controls these processes.
When Marcy, France's bioMérieux, a global in vitro diagnostics company, bought Organon Technika a few years back, the company inherited its Livelink licences. It ultimately decided to stick with the platform. According to Ted Walsh, bioMérieux project manager, MIS, global account manager, the company is now relying on Livelink as its global solution for electronic document management.
All of its content for regulated documents goes to Livelink, and document control uses it to track and record data about product quality. BioMérieux also just purchased a Web content management (WCM) platform, which Open Text itself bought about a year and a half ago.
""That is going to be delivering content to the Internet for us, but it will be regulated documentation. There's an open system and a closed system. Open systems are a lot more difficult to deal with. We've created an extranet where customers will be able to pick up package inserts, material safety data sheets, and that type of information over the Web.""
Walsh says this is done with ""seamless integration,"" allowing information to be pushed from Livelink, a controlled environment, to the WCM platform. Now users can be assured that their versions are always the most current, that the information they're publishing is up to date and that procedures within document control are sound.
North American users are all online, but implementation throughout bioMérieux globally is ongoing. ""It's not an easy thing to do because you have multiple silos of information across the world that you must look at, harmonize and bring into place on the Livelink platform.""
When pressed, Walsh, who was with the acquired company, says the decision to stay with relative newcomer Livelink did not feel risky.
Walsh says the biggest regulatory compliance headaches stem from country-to-country regulatory variances and the linking of different departments' and subsidiaries' silos of information.
For example, bioMérieux is moving to electronic signatures — it has a prototype in place to go paperless companywide and one site in the Netherlands that is already there. But even with a corporate directive in place, it's easier said than done.
""It's kind of a double-edged sword. Compliance to me really has to occur at the global level,"" says Walsh. ""Otherwise, you get into different interpretations and it becomes very, very difficult to come to an agreement as to what's compliant and what's not. And then if you have the FDA walking into each site, and if each site is doing different things, you have an issue.
""Where we run into a lot of problems is the communications across the different sites and just trying to get the business to think more in terms of regionally and globally.""
Sumner-Smith agrees. Penalties for deficient record-keeping can be extremely harsh. Regulatory authorities finding deficiencies in records keeping in one manufacturing plant might get fined, or told to clean it up. If they go to other plants and find similar kinds of problems it could lead to a shutdown, which could cripple a life sciences firm.
""They've started to say 'Look, this is a systemic pattern in your company. Each of your independent manufacturing plants in different parts of the world all have problems and you don't seem to be able to address them, probably because you as a company don't really have cross-company compliance processes.'""
As a result, CIOs and others are getting much more involved in trying to address, enterprise-wide, a consistent compliance environment that encourages the sharing of information that can be applied in every plant, rather than a set of home-brewed systems.
The company can't be tracking events if it has 20 different systems going, says Sumner-Smith. And often they do. Acquisitions and mergers are common. Most of the small biotechs are aiming to be acquired at some point by a big pharma at a big premium, and the big pharmas have been undergoing a lot of consolidation.
""It's very typical of our customer base for people to tell us they've got 50 different systems that do these kinds of things, so a lot of our efforts are on rationalization and trying to reduce the number of disparate systems and encouraging the sharing of information.""
That's tough, because companies often inherit old systems nobody knows exactly how to use anymore, and information in life sciences has to be kept for decades. It takes 10 to 15 years to develop a drug or device, the product is on the market for possibly 20 more years, and records must be kept for 20 to 25 years after a product comes out.
""It's many, many generations of software systems,"" says Sumner-Smith. ""So this is increasingly becoming a problem for these companies. How do they actually manage information long term if it's in any kind of proprietary system?""
""In a lot of cases, the only records they'll have from an acquired company are some paper records and some guy's lab book. They don't have the electronic form of the information if it ever existed, maybe from 20 years ago, even for a very key product somewhere on the market.""
Without enterprise content management systems, such situations would still be occurring, and the regulators would not stand for it. And without good systems and sound global policies and procedures, life sciences would have its own Enron equivalents being crucified in the courts right now.
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