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On another level, the FDA, reacting to the industry's desire to take advantage of the efficiencies of increased automation, has sought to regulate the means by which software-based systems obtain, transmit or store digital information. The envisioned goal is true paperless documentation of production and related data.
The stakes are high--and getting higher--for automation vendors to the pharmaceutical industry and the companies that supply them. Market-research firm IDC, Framingham, Mass., forecasts a $6-billion annual market for FDA-regulated industries in automation systems that can meet the evolving recordkeeping requirements.
The same pressure that the FDA exerts on frontline pharmaceutical manufacturing concerns gets passed on to contract manufacturers, business partners, subcontractors and system suppliers themselves.
"Many of the largest pharmaceutical companies will not do business with you unless you can validate your systems to their satisfaction," notes Winnie Cappucci, computer systems validation coordinator for Berlex Laboratories, Inc. of Montville, NJ. "You do the work initially to meet FDA requirements, but you are also aiming for a cross-pollination that validates your systems to clients and customers."
The need for validated procedures is even more clear-cut for a vendor providing devices or systems to pharmaceutical manufacturers. "We go through a customer qualification at our site just about every other month," says Don Smith, technology strategist at OSIsoft, Inc., San Leandro, Calif. "The auditor will review our software development procedures, then pull several programmers aside and use our code and test procedures in a live test. It can be a very demanding process, but we've had internal development methods and procedures in place for over a decade to cover this."
OSIsoft is the vendor of the PI system, a real-time data historian that can be used to record and store batch production data, then transmit it to manufacturing execution systems or other higher-level enterprise systems.
Seeing that numerous software developers are audited by pharmaceutical manufacturers, and recognizing the burdens this places on both the pharmaceutical company and the vendor, the Parenteral Drug Assn. (PDA) of Bethesda, Md., with some involvement from the FDA, has developed the Audit Repository Center (ARC) in Pottstown, Pa., as a source of standardized audits that can be used by multiple pharmaceutical companies.
Ideally, the audits, which are performed by ARC-trained auditors, can take the place of some or all individual customer audits, thus saving the resources that both vendors and customers have to devote to this process. ARC will re-audit a system whenever there is a major upgrade or, in any case, at least every other year. Pharmaceutical companies, who pay a subscription fee to ARC for the service, can download the audits as needed.
Although the process is proceeding somewhat slower than initially forecast, the effort is beginning to pay off. "We currently have 95 auditors trained and 52 subscribers from pharmaceutical companies," says Harvey Greenawalt, president of ARC. He says that new subscribers are coming in at a rate of a couple per month; meanwhile, in some cases, individual audits have been downloaded or referenced dozens of times, "and that represents a huge savings" for both the vendor and subscriber. "As word of this center gets better known, we'll grow bigger," he says.
Along the way, several interesting benefits have appeared. Some vendors will apply for an audit on their own as a means of pre-qualifying their products to customers. In addition, having the trained auditors as a resource helps everyone in the business get to a common standard of what should be in an audit. Berlex's Cappucci, who is also on the board of directors of ARC, says that "I am a big fan of this, even though I often use the audits as just a part of an overall evaluation" because it saves her and her company travel costs and time. "You could look on it as buying two free days of consulting work."
In practice, Cappucci says that her group still performs numerous in-person audits to meet Berlex's individual standards, but that the ARC material can speed up the auditing process and be used almost as-is for any follow-up or requalification of the vendor.
System Life Cycles
"Validation is a process, not an event." That is how Dan Matlis, vice president of business development at Stelex TVG, Bensalem, Pa., sums up the ideal approach to validation. "When you consider that 90 percent or more of the lifecycle of an automation system is spent in a maintenance phase, monitoring ongoing production--you have to think about controlling those ongoing costs to get the ROI you expect."
Indeed, there are a variety industry statistics floating around that indicate that only 25 percent of the lifetime cost of an automation system is spent in buying the hardware and software. The rest is consumed in installing the software, linking it with various networks, validating it and handling the ongoing upgrades and revalidations.
Stelex-TVG is unusual in that its scope ranges from systems integration and implementation through validation and business-practices consulting, and includes packaged software. Its software offering is ComplianceBuilder, an enterprise-level, file-and-message security system that uses private/public key infrastructure (PKI) code to authenticate electronic signatures.
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