Strategic decision-makers, QA and QC Laboratory Management, and IT professionals often ask whether they need a LIMS by 2017. Compliance with regulations is key to the decision along with managing customer expectations. Scott Schaefer writes in the Harvard Business Review that making good business decisions rests on assessing how the potential benefits and costs of a particular strategy pertains in each situation.
Mr. Schafer states that the answer to every business question is, “It depends.” The trick, he says, is knowing what it depends on. His research finds that there is no best path to business success. Managers address seemingly similar problems in very different ways and the trick is to find which solution fits with the specifics of the business.
Deciding on a LIMS is closely tied to complying with regulations. The Medicines and Healthcare Products Regulatory Agency (MHRA), an executive agency of the Department of Health in the United Kingdom, recently published industry guidelines on GMP data integrity, in order to help companies make data governance an integral part of the pharmaceutical quality system. Compliance with the guidelines is not a choice. The method of compliance with the guidelines is a choice, and like the answer to every business questions, it depends.
Data integrity controls apply to manual paper-based systems, automated computer-based systems, and hybrids (a combination of both). There isn’t a ‘one size fits all’ answer. This is the power of ‘It Depends.” The regulations state that some computerised systems have limited capability to meet data integrity controls. Where computerised systems have the ability, companies should upgrade to an appropriate system by the end of 2017. Where no suitable alternative computerised system is available, a paper-based method will be permitted. However, the lack of suitability of alternative systems should be justified based on a review of system design, and documented.
The right LIMS for your business can help meet both regulatory and client expectations. With modern software design and advanced technology, LIMS is no longer more expensive than manual systems and deployment into your QC Laboratory can be a galvanising team process for your business. The return on investment is extremely quick, giving immediate enhanced control over critical information on product and process quality, which is in the long-term interests of all stakeholders.