The partnership between software specialist Innovatum and labelling equipment firm Datamax aims to provide a focused solution for high volume, US Food and Drug Administration (FDA)-regulated production environments in the life science industry.
Datamax will introduce Innovatum software to clients who are subject to the compliance requirements of FDA 21 CFR Part 11, which dictates that manufacturers must keep auditable records of the use and activity of electronic systems that are used in production, including bar-code or RFID labelling.
Particularly highlighted is Innovatum's ROBAR label management system, which keeps an auditable electronic record of every label design, print change and authorization of every label's lifecycle, and is fully compatible with Datamax' printer hardware.
The system centrally manages all processes required to design and print unit, case and pallet labels, shipper labels, patient chart labels and clinical trial labels, and was built specifically for regulated manufacturers in the life science industry.
"This is really one of the first explicit commitments to pharmaceutical, biotech and medical device manufacturers in the auto-ID space," Patrick Kearney of Innovatum said of the Innovatum-Datamax alliance.
"Innovatum has formed smaller alliances at the VAR level, but this is the first alliance at the manufacturing level and the benefits to our mutual clients are numerous."
Kearney highlights how his firm's expertise lies in compliance, validation and software, and that the company can now bring in Datamax' know-how in consumables, printers and other hardware to hopefully provide a seamless service to end-users.
Initially the partnership will focus mainly on North American clients to give the alliance a chance to find its feet in the companies' home market, but according to Kearney is likely to become more global in nature over the next six to twelve months.
Innovatum is hoping for increased visibility through the newly launched alliance, driven by the increased exposure of its brand and opportunity to cite the widely respected Datamax name, as well as gaining insight into the Datamax business.
Datamax, for its part is hoping to gain a competitive edge through the alliance, and increase its opportunities in the highly regulated pharma and biotech industries in which Innovatum is highly active.
"Given the complexities of the regulatory environment, there haven't been a whole lot of choices for the industry in the past," said Kearney.
"But this alliance is a sign that there are companies paying attention to the market and its needs, and are willing to meet them."