To migrate or not to migrate? That is the question every laboratory information management system (LIMS) system administrator must face at some time or another.
Typically, a combination of factors system obsolescence, limited programming resources, changing business requirements provides the driving force for the change.
In evaluating the various financial benefits and risks, a compelling business case for migration often starts to present itself (see Table1). Why, then, is the prospect of migrating LIMS still so daunting and intimidating?
The main reason is that migrating from one LIMS to another can be a complicated and painful process. Among the biggest challenges are migrating data, dealing with existing configurations and customisations, and managing user acceptance and transition.
To overcome such challenges, planning a LIMS migration has become a complex matrix of time, cost, analysis, process, configuration, validation and training, with each of these elements presenting unique sets of further challenges and risks. This complexity and uncertainty means the cost side of the migration equation becomes imprecise, making the decision to move forward with a migration difficult.
Coupled with today's limited company resources for such projects, the situation demands a clear migration strategy and proven expertise from LIMS vendors. Such a strategy must directly address the biggest challenges associated with migrating LIMS and ensure the proper risk to reward ratio can be obtained.
Planning the migration
Why migrate? How much will the project cost? And how long will it take? These are among a host of questions that precede every migration project. Before any company can initiate a LIMS migration, some fundamental questions need to be clearly defined, understood and summarised as part of the migration project quality plan: u Why is the company migrating? u When does it need to be completed? u What is the expected business outcome and benefits? u What data will be migrated? u Who will be involved with the project from both the company and vendor? u Where is the performing, planning, and testing of the system going to occur?
Detailed upfront planning is imperative, since LIMS systems are often deeply integrated into the quality and decision-making framework of an organisation.
Business continuity and maximum productivity must be preserved. The business functions and interfaces supported by current applications all need to be taken into account as part of a planned transition to a new LIMS solution.
Documented process
A successful vendor migration strategy should be built on the foundation of a reproducible, documented migration process.
Such a process enables a vendor to offer a consistent approach to LIMS migration, removing much of the uncertainty and unnecessary complexity of a LIMS migration project.
Encapsulating the organisational experience and best practices learned from large numbers of migration projects into the underlying migration process helps ensure that individual migration projects can be performed more efficiently, consistently and with less risk of costly or time-consuming problems.
Professional services solutions are one successful method for delivering clear, concise and effective LIMS migrations.
Migration Agent from Thermo Electron Corporation combines a clearly defined and documented process, driven by professional services, with a toolkit and documentation and validation services to facilitate the migration from Legacy LIMS systems to the latest LIMS technology.
The embedded software toolkit enables customers to easily and predictably extract, translate and load LIMS data between the source and target systems.
A high level representation of Migration Agent's 10-step process is shown in Table2.
This well-defined process produces the effective and detailed planning required to minimise the transition impact of migrating to a new LIMS.
Having a defined, documented process enables the vendor to provide training to both staff and customer project teams on the migration process. This common understanding of the steps to be taken and the deliverables and documentation to be produced at each stage facilitates effective communications and reduces uncertainty.
Migration is about people
There are many reasons why software projects can fail, but without doubt ignoring the people issues is one of the biggest. Migrating to a new system introduces uncertainty to the end user community.
Migrating inevitably means a change to new or unfamiliar technology. Users may question why a new system is being implemented and may not feel involved in the decisions. This type of uncertainty is hardly conducive to a pain-free user acceptance process.
To counteract this uncertainty, a professional services approach provides the opportunity for end users to be actively involved in the migration to a new solution. In general terms, it is good practice to involve users at various stages of a project. End users should participate on the core project team and at key stages during the migration process. Include communication planning so that end users are kept informed and feeling involved. Provide adequate training before the transition.
In Thermo's experience, workshops have been a particularly successful mechanism to involve users in the early stages of a project.
Typically these workshops aim to take a number of scenarios through the target system with a wide coverage of work processes and functionality.
The objective is to make the best use of standard LIMS functionality, keeping the configuration as simple and minimal as possible. This approach can provide many benefits to all parties involved.
Training and support also have key roles to play in ensuring a seamless transition to a new LIMS system. A training curriculum for team members and key staff should be integrated with a migration plan, as well as a comprehensive support and maintenance agreement.
Vendors may also assist with developing customised training material to help end users with the transition from old to new, and an enhanced level of support for the period of the migration.
Migrating the data
The data in a LIMS system can be a company's most valuable asset as intellectual property, auditable quality assurance information or performance and business history. Is it really any wonder we view migration of data one of the biggest challenges/risks when migrating LIMS?
Not all data has the same value, and a migration process must be designed to take this into account. Choosing the most appropriate strategy to take with respect to historical data is best done on a case-by-case basis.
This can range from preserving and archiving the data, simply transferring the data to a new repository where it can be reported and consulted, to a full data migration so data assets can be actively used through standard LIMS functionality.
As well as the plan and processes to migrate LIMS data, a successful vendor's migration strategy also needs to include suitable commercial tools to extract, translate and load your data from source to target LIMS.
In the past, many LIMS vendors chose to build their own data migration tools since commercial-off-the-shelf (COTS) products were not available. Today's commercially available tools with open architectures enable easy transform development and also provide data analysis, filtering, and data migration workflow scheduling functionality. The advantage of these purpose-built tools is they will reduce the risk, cost, and time and are a proven technology.
Only with quality-assured tools, supporting documentation and an appropriate validation approach can the quality of migrated data be assured for future use.
Validation and migration
LIMS migration in a regulated environment is a task made all the more complex by the need for systems validation, as changes to a production system in a regulated environment will require validation.
Validation activities can be distracting for laboratory personnel since it diverts them from their core scientific roles.
One solution is to contract out the burden of validation to professionals who specialise solely in these tasks.
In order to minimise the risk and cost associated with validating a LIMS migration, it is worth keeping the following points in mind: u The amount of validation effort required is proportional to the amount of customisation and configuration of the target system. Deploying purpose-built commercial software reduces the validation effort required. u Risk assessment can be applied to the migration to focus validation effort on high-risk functionality with respect to regulatory compliance. u To minimise the cost of training, validation specialists should demonstrate in-depth product knowledge of the version of the software being deployed. u Practical experience reduces the risk of mistakes. Ideally, validation specialists should have practical experience in validating the target LIMS software, to enable them to recommend the most effective approach to validation.
Vendors with dedicated validation practices are ideally positioned to help with validation activities. The specialists in these teams can help ensure the most effective approach is being taken to validation activities throughout the migration project.
The benefits to be gained through systems validation are considerable.
In addition to facilitating compliance, further benefits include: greater management confidence in system performance, increased assurance of business data integrity and enhanced user familiarity with the system.
Conclusion
The pain of undergoing a LIMS migration can be mitigated by effective planning that addresses the various challenges involved. Successful migration planning, such as Migration Agent, involves a knowledgeable and experienced professional services team that employs process and toolkit to meet business needs and overcome challenges.
The processes and tools outlined here have been used by top-tier pharmaceutical companies for 21 CFR-related projects and have proven to significantly reduce the time and risk of a LIMS migration.
Mark Fish is Services Marketing Manager and Dave Minicuci is Product Manager with Thermo Electron Corporation, Informatics, Philadelphia, USA.
