Compliance Control Procedure Execution Management System Reduces Compliance Risks by 10X

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1 Compliance Control Procedure Execution Management System Reduces Compliance Risks by 10X By John Helfrich, VelQuest Corporation

2 INTRODUCTION The top drug GMP violations in 2009 involved failings in manufacturers' quality control units and failure to adhere to procedures and validation, with laboratory controls also having a top spot on the list. A common element of these top compliance issues is not following the written procedure/sop at the time of performance. With respect to laboratory controls, several key complaints include failures to follow test procedures and incomplete documentation in lab notebooks. These key human resource failures can be expected to be even more an issue as drug manufacturers move production and materials sourcing from in-house and local processes to off shore and often remote locations in their globalization efforts. As we move into the second decade of the 21st century, it is the objective of all life science manufacturing companies to minimize the risks of compliance non-conformance and the significant associated post-event costs. These costs are seen in human resource non-production time allocations, production delays or halts, and ultimately shut downs and product recalls with potential fines or consent decrees. The ultimate costs will be seen in the potential impacts to patients. These costs can mount into the 100 s of millions of dollars and, as such, should be at the forefront of boardroom discussions. Today, technology advances can provide an assured procedural compliance execution process that can be applied to any defined workflow. This procedure execution system is currently implemented in dozens of operations on a global basis and has demonstrated deviation reductions for compliance operations on the order of 10 times. REGULATORY PERSPECTIVE AND PROCEDURE EXECUTION Regulatory agencies on a global basis have done an excellent job of documenting the guidelines for drug manufacturers to produce and deliver safe and effective medicines. In fact, today the major agencies (US, Europe, Asia) are working to harmonize the regulations for global operations. Their goal is to modify the regulations to modernize and provide further clarification of the requirements for international cgmp standards. A key focus of the efforts centers on the FDA s regulations outlined in 21 CFR Parts 210 and 211 (Current Good Manufacturing Practice (cgmp) Regulations for Finished Pharmaceuticals). A pervasive element of all the regulatory commentary is the requirement for manufacturers to a) document what they are going to do, b) follow the document while you are doing it, and then c) document what you did. In summary, that is a central theme in the regulations. So it is creating the procedure/sop that you want your personnel to follow and provide assurances that the procedure was comprehensively executed. In fact, when you read the regulation you see comments such as the following: Subpart I Laboratory Controls, Testing and release for distribution described in written procedures such written procedure shall be followed Subpart F Production and Process Controls, to assure batch uniformity and integrity of drug products, written procedures shall be established and followed Procedures shall be established and followed. This is the central human control process for routine operations in the manufacture of drug products. To improve compliance-risk control, an automated electronic procedure/sop execution system is warranted. 2

3 PROCEDURE EXECUTION AND DOCUMENTATION PAPER VS. ELECTRONIC As mentioned earlier, a major cgmp 483 citation states the responsibilities and procedures applicable to the quality control unit are not [in writing] fully followed. This situation is pervasive throughout the industry. Many IT/IS systems (LIMS, ERP, MES etc.) that were intended to automate and provide electronic records of process activities are lacking automated controls for the realtime execution of the procedures. These systems are mostly results-oriented and not workflow-process oriented. In fact, with many of those systems, process or analytical results are captured manually and on paper, and then keyed into the system with little evidence of compliance with the procedure/sop. With the addition of a true procedure execution system, all data and most importantly, the metadata surrounding the result, is captured and cataloged in real-time, thus assuring compliant workflow for each procedure or SOP followed. Equally important to the procedure final result is the compliance metadata that supports the result. This includes items such as the compliance state (i.e. calibration status) of the equipment used, personnel eligibility to execute the procedure, expiration dates of reagents used in the process of analyzing materials, tracking and tracing of consumables used in the workflow process, and a host of other metadata components. A comprehensive procedure execution system must capture and catalog these metadata elements in real-time as the written procedure is followed. This is the control required for assured compliance with written procedures in cgmp operations. Another key opportunity for electronic systems (vs. paper) in quality operations is the ability to set thresholds for each step in the procedure or SOP and have the system watch in-real time as values are documented. Since production processes should yield virtually identical process step values, the electronic system can compare the actual values to the required specifications at each step in the procedure. Should a value fall outside of the expected norm, the operator/analyst is immediately warned before moving forward. This provides right first time opportunities and cuts deviation/compliance risks and subsequent investigation costs. The eight critical functional requirements for a procedure execution system are outlined in table 1. Procedure Execution Functionality The UI (user interface) IS the procedure Comment Regulatory requirements specify the actual viewing of the current procedure during workflow execution. Each procedure paragraph/step spawns the appropriate data and metadata capture needs for the procedure step, instruments used, and documentation input. Step-by-step control of the workflow execution by analyst/operator Data capture LINKED to procedure and can ACTIVATE other procedures in real time based on captured data entry This control element enforces required data and documentation with electronic verification of desired thresholds with compliance flags on any OOS situation. All instruments are checked for calibration state prior to taking readings. Ensures data and metadata are contextually linked to the actual approved procedure step. Data is captured direct to database for compliant recording (patented process). Procedures can be linked to create situational workflows (i.e. calibrate balance before use). Quality data elements are parsed from the entire instrument report at the same time as the cataloging of the entire instrument report output. 3

4 Data review dashboard view with compliance flags for streamlined review by exception Method Builder tool to automate existing documented procedures/sops Procedure-driven data exchange to other IT/IS systems COTS solution Procedure-based operational excellence Automates the aggregation of ALL data, metadata, supporting data (instrument reports etc.) with any OOS situation flagged for review. As a validated system, this provides reviewers with visual indication of what needs review vs. the need to review everything. This drives review and approval cycle times down by 50%-75%. Drag-and-drop technology to enforce best-practice procedure steps into existing document and automatically create validation script and workflow diagram for compliance documentation. These validated electronic workflows are captured in a method library for additional uses thus harmonizing ongoing lab and process workflows. Data import and export to and from other IT/IS systems (CDS, LIMS, ERP etc.) are driven by specific procedure steps and are linked to the source data and metadata. This provides a contextual linkage for compliance-based investigations, audits, or continuous improvement efforts in lab and plant operations. Off-the-shelf product vs. custom-coded project enables fast installation and validation. Methods scale up the system with Method Builder scaling up the methods enabling any business process workflows to be compliantly automated. Comprehensive set of rich data, metadata, and compliance flag info available for analysis/trending and process optimization from lab to plant. Table 1 Key capabilities for procedure execution in cgxp environments A PROCEDURE EXECUTION SYSTEM REAL-TIME VIEWING, DATA CAPTURE, CHECKING, REVIEW, AND DOCUMENTATION An example of such a system is seen in figure 1. This electronic procedure execution system displays the entire approved cgmp procedure or SOP to the operator/analyst along with a short work list view for ease of interpretation. It is then followed by a metadata capture functionality (i.e. calibration dates for balances) and data capture fields. Each step in the procedure is highlighted to assure the operator/analyst is viewing the actual approved procedure (in its entirety). Each step must be completed to close out the session and all data is captured directly to the database for compliant data management. 4

5 Figure 1 Procedure Execution System provides step-by-step viewing of the cgmp procedure, data and metadata capture, and real-time audit trail with compliance flag warnings to assure compliant adherence to regulatory requirements. All lab or at-line instruments are integrated to the system with their compliance states checked prior to capturing data. Audit trails are maintained automatically and final review and approvals are conducted with a dashboard view of all data and metadata. Data elements are electronically checked by the software, and should any data fall outside of the expected threshold, a compliance flag will appear to call attention to the reviewer (see figure 2). This capability has been published by users as saving 50%-75% of the cycle times for data review and approvals (ref. IMACS conference), further streamlining the operational excellence goals of the operation (see figure 3). Furthermore, using this capability reduces the lab or process deviations by a factor of 10 times (see figures 4 and 5). Figure 2 Procedure Execution Automated Data and Metadata Dashboard provides the aggregation of all procedural data in one place for QA review and approvals. Compliance flags point out where review is needed. This electronic review process provides 50% to 75% cycle-time reductions. 5

6 Figure 3 Cycle-time reductions for QC lab test results using an automated procedure execution system. (Source: BMS, IMACS 2006) Figure 4 Elimination of lab deviations by use of an automated Procedure Execution System. (Source: AstraZeneca, IMACS 2006) Task Write Up Results Review & Approve Average # Samples per Test Time Test % Hardness Appearance Dissolution Potency & Impurities Dissolution Potency & Impurities Paper Based 13 minutes 9 minutes 7 hours, 40 min. 12 hours, 40 min. 2 hours 2 hours ValQuest 3 minutes 3minutes 2 hours, 50 min. 6 hours, 30 min. 1 hour 1 hour Resource Savings 77% 67% 63% 49% 50% 50% DOING NOTHING IS NOT AN OPTION To thrive in today s economic and competitive marketplace, life science companies must drive operational excellence into all lab and production processes. An often overlooked critical risk is controlling the compliance-based documentation of procedures/sops that are the essence of everyday human resource tasks. By not automating the step-by-step human processes in operations, a significant potential cost to the company can result. Recently, we have seen product recalls, plant shut-downs, consent decrees, and operational remediation costs mounting into the 100s of millions of dollars. In addition, public company valuations have plummeted as a result of these multi-year remedies. At the senior management level, doing nothing is not an option. Automating procedure execution is the answer to minimizing compliance risks in cgxp environments. Figure 5 Deviation rate reduction for multiple plant QC/QA operations as a function of an automated procedure execution deployment. (Source: Eli Lilly, IMACS 2009) CONCLUSION To comply with the guidelines outlined by current GMP regulations, companies must ensure that human resources view, follow, and document written procedures. Many of the top 10 regulatory citations include non-compliance with operators/analysts failing to follow written procedures. Today, this is mostly a paper-based process with manual entry of results into an electronic system (LIMS, ERP etc.). By utilizing an automated procedure execution system, the resulting paperless environment assures that step-by-step compliance with written procedures is followed, all data and metadata is captured and cataloged, and review 6

7 and approvals are streamlined. From an operational excellence standpoint, significant benefits can be achieved including 50% to 75% cycle-time reductions, reduced compliance risks by 10 times, and harmonization of procedure/method/sop best practices across the enterprise. Figure 6 Method Builder tool provides drag-and-drop automation to create an electronic procedure execution implementation of standard documents (i.e. Microsoft Word). Method Builder automatically creates the validation documentation for the electronic procedure. About VelQuest Corporation VelQuest Corporation was founded in 1999 to address a critical requirement of the life science industry: How to leverage scientific resources to meet compliance regulations while increasing the productivity of people, reduce operational costs, and move finished product off the shipping dock faster than ever before. We remain committed to this mission, with GxP data management our ONLY business. Our flagship product is the award-winning SmartLab GMP Procedure Execution System and Electronic Notebook. The SmartLab system is an innovative software platform designed to provide the foundation for compliance-based activities in the life science markets. The core software embraces the ICH Q-10 initiatives, as well as the FDA s cgmps for the 21st Century: A Risk Based Approach, and Quality by Design (QBD) initiatives, and supports the company s SmartLab Applications for a fully compliant electronic laboratory and SmartBatch manufacturing batch record system. This patented technology eliminates compliance bottlenecks from paper-based processes in regulated development and quality operations. It captures all lab data at the source in real time, and seamlessly links procedures and SOPs with the data capture process. So not only does it reduce your compliance risk, it virtually eliminates tedious paperwork and dramatically simplifies reviews and audits. For more information visit VelQuest s website at. VelQuest Corporation John Helfrich VP, GMP Automation Programs 25 South Street Hopkinton, MA Phone: Fax:

8 About the author John P. Helfrich Vice President, GMP Automation Programs John P. Helfrich is the Vice President, GMP Automation Programs at VelQuest Corporation. At VelQuest, Mr. Helfrich is involved in the method translation of QC lab test methods to the software conventions used in the VelQuest SmartLab platform. Prior to VelQuest, Mr. Helfrich was the Director, Research Programs at NuGenesis Technologies Corporation. At NuGenesis his group was involved in the integration of the Scientific Data Management Software (SDMS) platform for instrumentation involved in proteomics, high throughput screening and bioanalytical applications of the biopharmaceutical industry. Mr. Helfrich has over 30 years experience in the biopharmaceutical industry as a research analytical chemist and divisional management of several high technology companies that service the life sciences industry. Prior to NuGenesis Technologies, Mr. Helfrich was the Vice President of Precision Detectors, a laser light scattering company involved in the characterization of proteins and antibodies. Mr. Helfrich spent 10 years with Waters Corporation as a business unit director in the pharmaceutical division and 8 years with Zymark Corporation as marketing manager and Vice President of the bioanalytical group. Mr. Helfrich began his research career as an analytical chemist in the preclinical research division of the Rohm and Haas Company. He has a B.Sc. degree in Chemistry and has authored 28 analytical chemistry and bio-characterization publications /10 8

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