A screen shot from Darwin, a laboratory information management system for pharmaceutical manufacturing, which features tools for environmental monitoring, stability testing, and content uniformity.
SOURCE: THERMO FISHER SCIENTIFIC
Pass the IT Implementation Test
A best practice approach helps when implementing an IT system
In the pharmaceutical industry, where validation and compliance with 21 CFR Part 11 is mandated, information technology (IT) system implementations can be fraught with difficulty and, in some instances, associated with a high failure rate. Nevertheless, the benefits these systems offer ought to heavily outweigh their costs. One critical success factor, which affects all other factors, is assembling an optimal project team with the right mix of skills, knowledge, and experience.
Selecting the Right IT System
IT system implementations, such as Laboratory Information Management Systems (LIMS), have evolved significantly over the past few decades, particularly with regards to their approach to 21 CFR Part 11 compliance. This could not be more evident than it is in today'S pharmaceutical companies, whose IT business requirements place significant demands on a system'S responsiveness, complexity, and ability to comply with government regulations.
The debate over build versus buy-whether to craft a LIMS or IT system in house or purchase them from an external vendor-has largely been decided in the pharmaceutical industry. In-house development is not a core competency of drug discovery or pharmaceutical organizations and is inevitably a costly and slow approach. The most compelling reason these systems are generally purchased externally, however, is that vendors now offer "purpose-built" systems that are designed to meet requirements specific to the pharmaceutical industry, including drug discovery, clinical trial management, research and development, and manufacturing.
Another question many organizations have asked over the years is whether the IT system should be monolithic or best of breed. For example, should LIMS functionality be provided by a module of an enterprise resource planning application, such as the quality module of the R/3 system from SAP AG (Walldorf, Germany)? Other options include a dedicated LIMS application like Darwin LIMS for pharmaceutical manufacturing, Watson LIMS for drug metabolism and pharmacokinetics labs, Galileo LIMS for in vivo testing, and Nautilus LIMS for high-throughput labs, all from Thermo Fisher Scientific (Waltham, Mass.).
The monolithic approach brings great advantages in consistency and efficient messaging between business areas, but best-of-breed applications from LIMS vendors offer significant advantages themselves. "Purpose-built" LIMS solutions are designed to meet a very high percentage of business requirements for pharmaceutical applications in the core product out of the box. For example, key functionality for pharmaceutical manufacturing, including environmental monitoring, stability testing, and content uniformity, is already built into the Darwin LIMS. Costly customizations, upgrades, and validation are practically eliminated with a group of software systems; upgrade activities can be subdivided into manageable chunks. Indeed, the same is true for initial system implementation, where prioritization and a low-risk approach with a phased rollout is an attractive option.
Project Team Selection
Whichever option is chosen, a critical success factor in the system rollout is assembling the optimal project team. In-depth knowledge of the business is vital; therefore, full-time assignment of in-house business area experts to the project team is highly recommended. In addition, with systems purchased from vendors, in-depth knowledge of the software is critical to success, and accumulating this in-house expertise can be a burden. A better solution by far is to acquire this expertise by hiring an external consultant. This can be a much more efficient and effective approach in spite of the initial bottom-line cost.
Regulatory compliance is mandatory in the pharmaceutical industry. There have also been seismic changes in the 21 CFR Part 11 landscape in recent years due to the Food and Drug Administration'S (FDA) risk-based initiative and court rulings, both of which add to the complexity of IT systems. The FDA is committed to revising Part 11, as stated in their 21 CFR Part 11 Final Guidance document. The same document also makes clear that, in the interim, the FDA intends to exercise enforcement discretion and a narrow interpretation of Part 11. Ensuring electronic record integrity, availability, and, where appropriate, confidentiality-as demanded by Part 11-is required to comply with numerous other best practices regulations. Employing a purpose-built LIMS solution that is designed to meet Part 11 compliance can greatly facilitate the process.
With systems purchased from vendors, in-depth knowledge of the software is critical to success, and accumulating this in-house expertise can be a burden.
Another factor to consider is the Utah Medical court ruling. Although Utah Medical is a medical device company, the court decision is significant for the pharmaceutical industry as a whole. United States Senior District Judge Bruce S. Jenkins ruled that the FDA can't dictate how regulated business will meet regulations. Enforcing "industry best practice," although it is not explicitly required by regulation, is an attractive option for a regulator with broad industry experience and has, in fact, been widely used by regulators in many industries and many countries. But such an approach would seem problematic in the light of this decision.
In the validation area, project team composition is, again, a vital consideration. Key areas of knowledge and experience include in-depth comprehension of business requirements, proficiency in the application area, command of the purchased software package and, finally, expertise in validation. Because finding all these attributes in one individual is unlikely, the optimum team is likely to comprise in-house specialists and external consultants.
Outside Advice
The use of external consultants is particularly relevant because the compliance landscape is shifting dramatically, and companies need to stay abreast of the latest changes to meet requirements. A validation expert can help a project navigate to a low-risk yet efficient route to compliance with knowledge of the various approaches that have been taken by others in the pharmaceutical industry.
Another aid that can be used to help organizations determine the best path to achieve Part 11 compliance is to obtain the Good Automated Manufacturing Practice (GAMP) forum'S Good Practice Guide, "A Risk-Based Approach to Compliant Electronic Records and Signatures," available at www.ispe/gamp.org. The GAMP forum includes representation from the pharmaceutical industry and software vendors and has close relationships with regulators in Europe and America. The aim of the GAMP guidance documents is to provide a unified reference source for regulatory compliance and industry best practices in the IT arena.
Many of the challenges inherent in selecting and implementing an IT system can be overcome with a best practice approach in place. While managing risk, utilizing GAMP guidance, and selecting a system that is purpose-built for your application needs are all important factors, perhaps the most critical is assembling an optimal project team with the right mix of skills, knowledge, and experience. �
Dickson is a consultant with the Informatics Services Group specializing in validation services at Thermo Fisher Scientific. For more information, call (866) 463-6522 or e-mail marketing.informatics@thermofisher.com.
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