SubscribeIn the strictly regulated environment of the pharmaceutical industry, implementations of IT systems such as Laboratory Information Management Systems (LIMS) need careful management.
However, if organizations take the time to carefully plan an implementation strategy these systems offer considerable ROI benefits in terms of increased performance, productivity, and regulatory control which greatly outweigh the costs. This article provides an overview of the regulatory environment in the pharmaceutical industry, discusses the advantages and disadvantages of different types of IT systems, and advises organizations on the best approach to take when assembling the optimal project team with the right mix of skills, knowledge and experience.
Changes in the Pharmaceutical Regulatory Environment
Regulations governing the operations of the pharmaceutical industry are becoming increasingly stricter. Over recent years, the 21 CFR Part 11 framework has changed substantially mainly due to the introduction of the FDA’s risk-based initiative and the Utah Medical court ruling. Part 11 requires that pharmaceutical companies ensure electronic record integrity, availability and where appropriate confidentiality in order to comply with other GxP regulations. According to the 21 CFR Part 11 Final Guidance document, the FDA is committed to revising the rule [ref 1]. It is also stated that while revising Part 11, the FDA also intends to exercise enforcement discretion and a narrow interpretation of the rule.
The Utah Medical court ruling issued in 2005 [ref 2] has affected considerably the compliance landscape within the pharmaceutical industry. The ruling specifies that the FDA cannot dictate how regulated companies will meet regulations. Implementing ‘industry best practice’, which is not explicitly required by regulation, is an attractive option for a regulator with broad industry experience, and in fact has been widely used by regulators in many industries and many countries.
Pharmaceutical companies can achieve Part 11 compliance by obtaining and following the GAMP Good Practice Guide, ‘A Risk-Based Approach to Compliant Electronic Records and Signatures’. The GAMP (Good Automated Manufacturing Practice) forum is comprised of representatives from the pharmaceutical industry and software vendors while also having close relationships with regulators in Europe and America. The aim of the GAMP guidance document is to provide a unified reference source for regulatory compliance and industry best practices in the IT arena.
Employing a purpose-built LIMS solution that is designed to meet Part 11 and GAMP compliance can greatly facilitate the validation process and reduce implementation costs and risks.
Deciding on the Best Software System
The past few decades have seen considerable advancements in implementations of IT systems especially in the extent to which such systems have evolved to ensure 21 CFR Part 11 compliance. Change is particularly evident within the pharmaceutical industry since drug manufacturers, more than anyone else, require IT solutions that are increasingly responsive, less complex and able to comply with government regulations.
For many years, there has been an ongoing discussion around the issue of whether pharmaceutical companies should build IT systems in-house or instead acquire them from an external vendor. This debate is now largely over and purchased systems have prevailed since drug discovery and pharmaceutical organizations do not have the expertise required for in-house development of efficient IT systems. Furthermore, this process has proven expensive and time-consuming. To keep up with this growing and complex market need, LIMS vendors have developed “purpose-built” systems to meet specific requirements of the pharmaceutical industry from drug discovery and clinical trial management to R&D and manufacturing.
A further dilemma that pharmaceutical organizations have been asked to deal with is whether an IT system should be monolithic or best-of-breed. Monolithic systems offer significant advantages in terms of reliability and competent messaging between business areas. Best-of-breed, “purpose-built” LIMS solutions, on the other hand, are suitable for the majority of pharmaceutical applications providing fast and accurate results “out-of-the-box”. For example, Thermo Scientific Darwin LIMS™ features standard, built-in functionality especially for pharmaceutical manufacturing, including Environmental Monitoring, Stability Testing and Content Uniformity. Thermo Scientific Watson LIMS™ has been specifically designed for DMPK laboratories, Galileo LIMS™ for in-vivo testing and Nautilus LIMS™ for research environments. Contrary to monolithic systems, best-of-breed software solutions eliminate the need for expensive customizations, upgrades and validation.
Building the Best Project Team
Formulating a competent project team to undertake the IT system implementation process is of utmost importance no matter which type of software has been chosen. The project team should be a combination of in-house business area experts and external consultants. The former will bring to the team their thorough knowledge of the business and the latter will add the necessary in-depth expertise of the vendor bought software and years of experience with other implementations.
The composition of the project team plays a further crucial role with regards to regulatory compliance and validation. Again, a marriage of in-house specialists and external consultants will ensure optimum comprehension of business requirements needs, proficiency in the application area, command of the purchased software package and expertise in validation. A validation expert with deep knowledge of the various approaches employed in the pharmaceutical industry can help towards a low-risk yet efficient route to compliance.
Summary
A best-practice approach can help pharmaceutical organizations overcome many of the challenges they face when selecting and implementing an IT system. While risk management, GAMP guidance and purpose-built software solutions are all necessary success factors, building a proficient project team with the proper mix of skills, knowledge and experience is considered as the most significant.