The U.S. Food and Drug Administration's (FDA) increased scrutiny of manufacturing operations as a result of 32 CFR Part 11 has placed new demands on pharmaceutical and biotechnology manufacturers, forcing them to re-evaluate the technology necessary to maintain regulatory compliance. The FDA designed the regulation to guide life sciences manufacturers' handling of electronic records, signatures, authorization processes, data security and traceability. 21 CFR Part11 was introduced more than five years ago, so why are the majority of manufacturers still not compliant? Many have been putting off compliance projects until the industry has better answers to two important questions: How can technology ensure compliance? And, more importantly, how will compliance impact the bottom line?
To answer these questions, companies must first understand the potential cost of not complying with 21 CFR Part 11. Part 11 has the attention of executive management, since the cost of complying is expected to exceed the investment in Y2K rectification, with estimates ranging into the hundreds of millions of dollars per company. But the cost of non-compliance and its potential negative impacts on customers far outweighs the necessary investment in compliance-enabling technologies, which come with fringe benefits. Part 11 compliance presents an opportunity to upgrade manufacturing and quality management as a whole.
Improved profit margins by better producing to specification and schedule.
Even though these potential benefits are desirable, Part 11 implementation delays continue because of two fundamental technology-related issues. First, even though more than 150 technology vendors claim they can help with Part 11 compliance, there are few solutions that offer an enterprise-wide approach to achieving compliance. Secondly, a wide range of legacy systems - some 12 to 15 years old - provide disconnected portions of the needed data and create a significant challenge.
The solution lies in leveraging existing data systems in a way that lends itself both to meeting FDA requirements and to improving manufacturing operations. To be truly useful, the mountains of data gathered during the manufacturing process - from raw materials to product - must be easily available for informed decision-making in time to impact the next batch of product. Unfortunately, in most plants today, it takes weeks or months to get the right data from across departments and widely dispersed data sources.
Thankfully, emerging technologies are now available that can be combined with improved process management to achieve compliance and - as a welcome side benefit - gain significant global operating efficiencies. These technologies leverage and add value to systems already in place, such as LIMS, SCADA, MES, paper batch records and ERP. They can quickly made data available from disparate sources and, for the first time, give manufacturers a single point-and-click view of the data in a complete environment for data-intensive decision-making, presenting new opportunities for manufacturing improvements.
Aegis Analytical Corporation's Discoverant® is a solution offering a comprehensive, enterprise-wide strategy for achieving compliance in data-intensive areas. An initial benefit is the software's ability to allow the efficient conversion of data on paper recors into electronic form in full compliance with Part 11. AMR estimates that 80 percent of pharmaceutical and biotech manufacturing data may be contained in paper records, creating and enormous need for this solution.
Combinig paper-based data with data from multiple databases throughout a global organization gives any user the ability to reverse adverse trends, stabilize variability, identify root causes, and enable data-intensive decisions in relevant time (i.e., in time to improve the next batch). Leading pharmaceutical and biotech companies who have implemented Discoverant have leveraged it to meet regulatory and operational requirements.
Regulatory Benefits
Controlling the entire manufacturing process versus only monitoring and controlling separate unit operations is a practical necessity in today's world. Fast access to data from disparate sources, including paper records, using a fully Part 11 compliant system is essential to identifying and controlling combinations of critical process parameters - wherever they are found in the process. There is little realistic possibility of doing this by continuing the "spreadsheet madness" if the past. Because Discoverant is specifically built for the FDA-regulated life sciences environment, it offers this kind of data access along with sophisticated, yet easy-to-use, decision making capabilities that enable manufacturers to maintain a complete, validated environment and consistent regulatory compliance.
Operational Benefits
Discoverant delivers several enterprise benefits by integrating visual, animation and reporting capabilities needed to turn data from multiple sources into actionable intelligence that improve manufacturing operations and the bottom line. For example, Discoverant's Curve Metrics™ capability extracts selected features, such as rates, areas and times, from continuous data and turns it into new parameters for investigative analysis. The software's functionality improves manufacturing performance through reduced numbers of start-up runs, minimized plant shutdowns, shorter trouble-shooting times, fewer atypical outcomes and increased yield and quality.
The massive amount of data generated in the manufacturing process has very little value if it takes weeks or months to gather for decision-making. Discoverant provides live, direct, read-only access to all disparate data - including paper records - to give manufacturers the ability to meet FDA requirements. The software eliminates potential errors that can occur when thousands of values are entered into separate spreadsheets manually, which is required by most decision-making tools. This improves data integrity while enabling faster results and more efficient FDA reporting and traceability.
Although 21 Part 11 presents a significant challenge for pharmaceutical and biotech companies, the regulation isn't designed to put manufacturers out of business. Instead, it establishes best practices for electronic record keeping and provides an opportunity for companies to enhance their existing operations through a combination of technology and business process solutions. In achieving Part 11 compliance, companies reduce the risk of regulatory fines and damage to their customers, and benefit from streamlined operations that lead to increased profitability. New technologies, like Aegis' Discoverant, provide manufacturers with a complete environment for data-intensive decision-making that enables both regulatory compliance and a positive bottom-line impact.
