Records Management Solutions

Armedia Records Management Solutions provide effective, efficient, and compliant applications using leading industry platforms and best practices. Our solutions are tailored to meet your industry’s regulatory requirements while wrapping them into the organization’s specific business processes. We employ key records management techniques and implement them in a way that meets the client critical needs and constraints. We focus on our client’s key requirements and take the time to listen and understand their challenges as well as goals and objectives so we can deliver the best technical solution on time and on budget.

More Control. More Efficiency. More Accessibility.

Lay out a road map. Reduce your risk.

Whether you are faced with DoD 5015, 21 CFR Part 11, HIPAA, Privacy Act, SOX, SAS 70, MoReq2, etc., Armedia understands the regulations and how they need to be applied to your records management solution to ensure compliance while not being costly or obtrusive. Organizations today are faced with the overwhelming burden and cost of managing records in various systems and formats. Most companies are challenged with where to even start—Armedia is skilled in assessing an organization’s needs, defining their risk, and laying out a strategic road map to manage your records.

Armedia provides comprehensive records management solutions to reduce compliance risk, using strong security matrices, and implementing retention policies so records can be dispositioned appropriately. We ensure clients address a 360 degree plan, even if they decide to take one step at a time, focusing on helping to create key records management principles.

Another critical area we key on that often gets overlooked is human factors. If the system is too difficult to use or takes too long to perform tasks, then users will not adopt the system. We work with key stakeholders and business users to design a system and interface that makes sense and promotes higher efficiency and greater utilization.

All of these focus areas, coupled with our extensive understanding of the technologies, proven methodology, and project management expertise, make Armedia a complete solution provider for any organization’s records management needs.

Life Sciences

The Life Sciences industry has extensive records management requirements along with complex business processes. Organizations in Life Sciences are required to submit regulatory information to one or more of the FDA’s six centers. Regulatory submission processes are very complex and comprised of many different groups within an organization all authoring, editing, reviewing, publishing, or approving records of some kind. All of these records are bound by regulatory compliance constraints, 21 CFR Part 11 and HIPAA among others. Complicating this even further is the fact that very often this information is stored in several different systems in various formats.

Armedia focuses on making sure regulations are being met while unifying the content and processes systematically so variability is reduced and results are more reliable. It is critical for organizations to provide timely submissions to meet their goals and obligations. A significant amount of time and money is lost by regulatory affairs specialists trying to track information down that needs to be included and correct and meet submission deadlines. In some cases as much as 70% of regulatory employee’s time is spent trying to track down regulatory content or trying to track down the correct versions. Armedia focuses on eliminating that waste so those specialists are free to focus on work that contributes directly to the organization’s bottom line and ensuring that all content is compliant and auditable.

Some key areas we focus on are system integrations to streamline the process and create more effective use of your company’s software investments. In some cases system consolidation is warranted but only if core competencies are being met by multiple technologies and other constraints do not prohibit such a move. Key system integrations for organizations within Life Sciences might be the Enterprise Content (Records) Management System, CAPA/Audit System, Product Lifecycle Management, and Regulatory Submission Publishing System. Armedia focuses on key industry standards such as eCTD, SPL, and the newer RPS (Regulated Product Submission). RPS is an electronic messaging standard endorsed by the FDA that is meant to encompass all regulatory submissions (Pharma, Med Devices, Vet Meds, Food, etc.). Additionally, RPS is an HL7 (Health Level 7) standard and is intended to be used not only in the US but worldwide.

FDA

Armedia is experienced at implementing solutions using the FDA’s ESG (Electronic Submission Gateway) to deliver regulatory submission information to the agency. The ESG is the FDA’s preferred method for receiving regulatory information and Armedia has developed solutions to transmit regulatory submission via the ESG rather than mailing electronic media or paper. An efficient regulatory submission process funnels to regulatory affairs specialists so they can compose the submission package. Once it is reviewed and approved, it can be published (in eCTD, RPS, etc.) and submitted electronically to the FDA via the ESG.

Case Studies

Keata Pharma in Arnprior Canada uses their PDOCS system to author, control and publish all of the company’s Standard Operating Procedures (SOP) for the precise blending, manufacturing and labeling of every product manufactured within that facility. In the highly regulated pharmaceutical industry, these SOPs are critical to the entire manufacturing process and to the integrity of that process. Keata was faced with having to transition to a new network and when they did, the system became unstable and ultimately would not start. For the client, it was a situation that required expert knowledge and quick action. While Keata had developed some workarounds to produce hard copies of the SOPs already in the system, they could not operate in this manner for long. SOPs are in a constant state of change. They must be kept up to date when there is a change in the manufacturing process or when new products are introduced. Keata contacted Armedia, who assembled a team of experts to conference with members of Keata’s IT group and assess the situation. Within hours of arriving on site, Armedia was able to resolve the issues and bring the PDOCS system back online, as well as stabilize it so it was more reliable for the future.