The Cost of Compliance
Industry analysts say that the regulatory compliance burden on businesses is large and increasing. It is estimated that in the past 5 years, over 10,000 new regulations have been created by federal and industry bodies. AMR Research predicted that $80 billion has been spent on compliance programs between 2005 – 2010.
For the chemicals industry, regulations such as REACH apply. In addition, for pharmaceuticals, life sciences, and medical devices, numerous Food and Drug Administration (FDA) regulations, such as 21 CFR Part 11 apply. Emissions and environmental regulations, e.g. carbon cap and trading, apply to all process manufacturers.
As computer documents replace paper records in the fields of R&D, manufacturing, and other functions, companies need to understand, manage, and control the flow of digital information.
The FDA requires that these systems maintain the digital equivalent of a paper trail. Regulation 21 CRF Part 11 sets strict criteria for electronic signatures and documents. Non-compliance means fines, delays and even, ultimately, shutting down of operations.
Compliant Collaboration
Existing electronic content management (ECM) systems provide document control — but at the expense of efficiency and ease of use. Because outside collaborators have trouble accessing these systems, the pace of research suffers. The systems are not intuitive, so even internal users become frustrated.
Add to that the inability of existing systems to store metadata — filing tags such as authors and dates and other important contextual information — within documents. Critical information becomes unavailable whenever a document is checked out of the system. Besides crippling the document search process, these systems make managing the “corporate truth” impossible. These systems are expensive, yet offer little benefit over paper records. They impede collaboration — and waste precious time as critical patent protections run down.
Life sciences firms need ECM systems that satisfy the requirements of 21 CFR Part 11. Systems must provide audit trails, electronic signatures, strict access control, accurate copies, and proper storage of all document versions. They must be validated to produce reliable, accurate information. But the needs of business exceed FDA regulations. A system must be intelligent and easy to use, so team members around the globe can upload, store, and search documents that preserve content with its valuable associated metadata.
Our ECM systems are delivered in environments that can be validated for regulatory authorities. Our solutions use the power of the Microsoft platform to provide an easy to use ECM system that allows customers to keep the total cost of ownership down while driving adoption up. This is in stark contrast to the traditional ECM vendors.
Designed for R&D organizations, Microsoft Amalga Life Sciences 2009 aggregates data from disparate systems, both from within an institution and from partner organizations, helping them move faster, with more agility, and with purpose and direction supported by validated facts. This allows researchers to address many data challenges from a single system and transforms the way they are able to perform their research.
Environment and Sustainability
Another area of growth and complexity of new regulations is around the environment and sustainability. Greenhouse gas concerns, CO2, carbon footprint, and carbon cap-and-trade are all issues that affect process manufacturers, in addition to long-standing requirements to monitor plant emissions. Furthermore, more and more companies are making “green” and sustainability an essential part of their marketing. Having the data on-hand to support sustainability claims is a must.
For many process manufacturers, energy is a large part of their operating expense. Reducing the amount of energy consumed in the plant makes a lot of sense economically in addition to its environmental benefits.
Companies have traditionally managed their emissions at the plant level with a mix of automated and manual processes. Beyond the single plant, processes have been largely manual. Process manufacturing companies are now faced with the challenge of global emissions management across multiple plants, continents, and countries, with different regulatory frameworks in different regions. They need to report of their emissions globally in a unified way. In addition to records of emissions, they also need to track inventory of chemicals (both products and feedstocks/ingredients) as well as waste shipments.
The Greening of the Datacenter
Microsoft itself operates some of the largest datacenters in the world and is pioneering efforts to reduce the amount of energy used to run them. With the growth in the size of datacenters, many companies are also looking to apply some of these techniques to their own datacenters to contribute to their overall corporate sustainability endeavors. Virtualization is a key weapon – running multiple servers’ workloads on a single server – using Windows Server Hyper-V. Furthermore, Microsoft partners’ solutions enable monitoring of energy consumption, integrated with other enterprise applications, in order to drive down energy consumption.
Microsoft and Its Partners Can Help
Microsoft has partnered with industry-leading solution providers to deliver a broad range of compliance solutions. Our combined solutions are intuitive. They leverage a common interface that integrates familiar office applications with line-of-business systems. They allow remote users to collaborate in real time from anywhere in the world and facilitate users to interact with systems and other applications within the familiar office business applications they rely on to view, create, and modify business documents.