Armedia Announces Regulatory Compliance Success

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The Armedia regulatory compliance team recently successfully concluded a 21 CFR 11 compliance development and validation effort for Atlanta based pharmaceutical, Mikart, Inc.

“The biggest challenge was dispelling the myth that compliance validation is a one-time event where everything is done in a few weeks and we are good to go,” said Joe Tribble, Mikart Operations Manager. “Validation is just the starting point; the entire lifespan of the system requires a constant human adherence to the plans and guidance defined during the validation event. Realizing this, Armedia developed a process for Mikart to manage security and operation of our electronic systems to ensure compliance on a day-to-day basis.”

Mikart is also expanding the capabilities of its Documentum Enterprise Content Management system and engaged Armedia to help in this endeavor. With the use of Documentum Control Manager, Armedia automated Mikart’s Standard Operational Procedure (SOP) processing to eliminate previously manual tasks that were lengthy and cumbersome. Under the new process SOPs are created and automatically routed for approvals (via electronic workflow) and capture electronic signatures as they are approved. The automated process places the current-version of an SOP into a central repository to revise and edit, and subsequently moves approved versions of SOPs to a read-only location for consumption.

The immediate benefits to Mikart include:

• Assurance that SOPs are always current for employees

• Rapid approval of SOPs, especially important updates to them

• A time-stamped audit trail to mitigate risk

• Electronic signature upon approval

“We are very pleased to have helped Mikart achieve new efficiencies in their SOP processing and FDA compliance,” said Jim Nasr, Armedia Chief Executive Officer. “Mikart’s investment in improved processes and supporting technologies provides them a strong foundation for long-term operational compliance and effective electronic document management. We look forward to helping Mikart meet any additional requirements in the future.”

About Mikart

Mikart is a recognized leader for providing formulation development, contract manufacturing and packaging services to the pharmaceutical industry. They offer a broad range of capabilities including product development, analytical services, solid and liquid oral dose manufacturing, packaging and regulatory services.

About Armedia

Armedia is a leading consulting and integration firm, headquartered in Atlanta, GA, specializing in content management and content related solutions. Armedia's mission is to provide world-class solutions for clients to automate the creation, capture, organization and presentation of their intellectual assets. Armedia has offices in Atlanta, GA and Fairfax, VA.

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