For highly-regulated environments such as the pharmaceutical industry, for example, purchasing a piece of software is only the first step in a process that involves hard work and high costs before it can be truly integrated into a company’s workflow. This is known as ‘validation’.
The validation process involves several stages, starting with an outline of user requirements and a function and design specification, through to a review of the installation, an operational test of the system, and finally a performance evaluation.
The validation plan might also include other items, such as: planning, design/testing, scope, acceptance criteria, change control, risk management and handling deviations. One also needs to take into account existing project and system SOPs, team computer systems training, end user training, and a completed validation report. Only when all these factors have been dealt with can the validation execution begin.
The validation impact
Once everything works out as planned, the relevant deviations have been identified and resolved and the validation report is complete, you can then train your users and go live. For a LIMS in a regulated environment, the typical time between first discussions and going live can be anything from eight months to two years.
During an implementation, the validation effort alone normally accounts for 40 to 60 per cent of the project time and cost. Validation cost is one reason why it is very difficult for a company to implement a system in a regulated environment. In addition, the cost of revalidation for the customer will prominently figure in the decision to move to new versions of the software or apply ‘nice-to-have’ patches.
Common solutions
To get a true COTS solution, the question that first should be asked is: ‘Are there common requirements within an industry?’ If so, can there also be common solutions to meet those requirements? Where systems are being installed in a regulated environment for the pharmaceutical industry, the answer is probably yes and no.
The problem is that in many cases, the laboratory business processes are seldom well defined, documented or harmonised. Also, any effort to do so is inherently expensive and fraught with cultural and operational challenges. The generic vendor solution to a requirement is probably never a best fit for the specific needs of the user community. So the challenges for a successful COTS LIMS implementation seem very big.
However, the main driving force, the regulating agency such as the FDA, is pretty consistent on what they are asking to be delivered (requirements) and how quality should be addressed (validation). It is fair to say that all LIMS vendors pretty much meet these requirements in one way or another. The vendor is uniquely positioned to utilise its experience to help create an industry ‘best fit solution’. Some of the systems are so complete in the out of the box functionality that the opportunity to be a truly pre-validated COTS solution is there. The problem of establishing which common solutions meet the industry requirements is the biggest obstacle in creating a COTS prevalidated LIMS.
At a time when money is key, the need to reduce implementation costs without reducing quality and still allowing for a future upgrade path is more important than ever. For LIMS, a pre-validated COTS solution is an answer.
Vendor help
As far as organisations such as the FDA are concerned, the responsibility for compliance lays with the drug or drug device manufacturer, rather than the LIMS vendor. However, the latter can provide the tools and documentation to assist the customer. In fact, the vendor can provide the main set of deliverables the customer would need to go live with a validated system.
For a successful pre-validated COTS LIMS solution, the vendor should provide the following: project management; design and configuration; computer systems validation (CSV) training; requirements; end user SOPs, workflows and life cycle documentation; development; installation, operation and performance quality assessments; traceability matrix; validation registry; and a validation report.
Customer responsibilities
The customer is still responsible for ensuring that the purchased product has been properly validated and implemented in their facility according to all its practices and standard operating procedures. This means the customer will still need the services of its quality assurance department to sign off the validated product. The customer will need to perform vendor audit (factory and validation); gap analysis; validation plan; supplemental validation; validation wrapper; and validation report.
As a general rule, a customer should expect about an 85 per cent fit of the pre-validated COTS LIMS solution to the final system implemented. The more a customer can change the way things were done in the past, the higher the fit.
COTS benefits
If a vendor does its job right and a customer can bend to some generalised solutions, the customer stands to save a considerable amount of money and time during a LIMS implementation project. For example, savings on a $720k LIMS implementation might be around $480k, with the timeframe reduced from up to 18 months to fewer than three months.
Many LIMS implementations fail not because of a lack of funds, but from the demand on in-house resources. The appropriate resources that a customer would usually like to utilise are already tasked to other projects. This is where a well-resourced vendor can help.
The time has finally come when a vendor can provide a true, pre-validated COTS solution. This provides real savings to the customer and allows the vendor to differentiate itself from its competitors with a modern solution.
