Effective Information Management ebook

Transcription

1 Ensuring Quality and Compliance with Effective Information Management ebook

2 REGULATORY COMPLIANCE: THE WARNING SIGNS OF INADEQUATE CONTENT MANAGEMENT PAGE 3 TABLE OF CONTENTS ISO 9001 CERTIFICATION IS IT WORTH IT? PAGE 5 HOW CAN MANUFACTURERS KEEP THEIR DOCUMENTS UNDER CONTROL? PAGE 8 GMP AND DOCUMENTATION 5 BEST PRACTICES PAGE 10 WHAT IS BIG DATA TODAY? BIGGER CHALLENGES FOR BIG DATA IN LIFE SCIENCES PAGE 13

3 Regulatory Compliance 03 Companies that operate in highly regulated and frequently audited environments are often challenged with managing an ever-growing mountain of compliance documentation. In the U.S. alone, there are more than 15,000 federal, state and industry laws, standards and regulations that dictate how long to keep paper and electronic records. REGULATORY COMPLIANCE THE WARNING SIGNS OF INADEQUATE CONTENT MANAGEMENT THE POTENTIAL COST OF NON-COMPLIANCE IS HIGH Conduct pilot tests and proof of concept exercises via free trials. If you find that an ECM solution evaluation is taking up too much of your time, consider this a red flag and cross the product off of your list of alternatives. With crippling fines and liability issues that can result from non-compliance, the stakes are high for companies to ensure they are managing their compliance-related information in accordance with mandates. However, many companies still maintain manual processes for routing, filing and organizing compliance-critical documentation. These error-prone and time-consuming practices present a major risk and can easily compromise a company s ability to meet FDA, cgmp, ISO 9001 and other regulations and standards.

4 Regulatory Compliance 04 Given the high priority for regulatory compliance and the amount of documentation required to prove compliance, it is no longer practical to manage the content separately from compliance efforts. If compliance management teams are asking themselves the following questions, chances are their organization is at significant risk for non-compliance due to inadequate content management practices and procedures: Where is the gatekeeper? Do compliance management processes slow or stop production when a key person is sick, on vacation or exiting the company? Has everyone read the latest compliance-related communication? Is it difficult to get the accurate status about compliance-related tasks, procedures and workflows? Are policies being followed and schedules being met? Who has visibility over the completion of the specified processes? Where are the required signatures? How easy is it to locate the documents that verify the approval processes? Have all of the audit issues been resolved? Are employees and managers barraged with repetitive reminder s while the status of essential action items remain unclear to key stakeholders? Is compliance slowing down the business? Is the organization at a competitive disadvantage because it takes a long time to adjust to the latest regulatory compliance requirements? ECM ENABLES ENVIRONMENTAL CONTROL To address these vulnerabilities, organizations should consider aligning compliance management with best-in-class enterprise content management (ECM) solutions and approaches. With a consolidated and unified system for managing compliance-related information, a broad range of structured data and unstructured content can be quickly and easily searched, viewed and managed from any location, which significantly streamlines the regulatory management process while also substantially reducing the risk of noncompliance due to manual errors and lost information. The introduction of a centralized ECM solution also promotes automated compliance-related workflows. In addition to defining and controlling document access permission levels, compliance teams can establish automated notifications and communications to the individuals who are involved in various compliance-related processes. Organizations can automate the enforcement of policies and procedures that actually save time and boost productivity while also ensuring tasks are completed according to compliance requirements. By leveraging an ECM system to manage compliance-related content and associated processes, companies can increase information control and visibility while significantly reducing their risk of regulatory compliance violations.

5 ISO 9001 Certification 05 The ISO 9000/9001 family of standards related to quality management systems help businesses better serve their customers and simultaneously comply with product-related regulatory requirements. More than a million businesses and suppliers have been certified as ISO compliant based on the criteria defined in the ISO 9001 standard. ISO 9001 CERTIFICATION IS IT WORTH IT? There are many reasons why businesses continue to join the worldwide ISO 9001 community. The standard has gained acceptance to the degree that many major global corporations and organizations require ISO 9001 certification from their partners and solution providers. The roadmap it provides for quality management has been proven over more than five decades to help lower risks, especially in regulated industries.

6 ISO 9001 Certification CERTIFICATION EQUALS BOTTOM LINE IMPROVEMENT Often times, certification and compliance initiatives can bring companies to sink-or-swim moments. This is true for the ISO 9001 certification process, which requires the compilation of documentation that can either drown an organization or motivate them to deploy and leverage an enterprise information management (EIM) system in order to effectively manage both their ISO 9001-related content as well as other core information assets. A best-in-class EIM solution can manage and streamline ISO 9001 requirements with many features and capabilities that simultaneously drive up overall productivity and business efficiencies. Fläkt Woods is a great example. One of the world s leading manufacturers of air handling units, the company s deployment of an enterprise information management solution has not only enabled effective document handling for ISO certification, but it has also resulted in a significant reduction in design errors due to outdated versions of documents, as explained in this excerpt from Fläkt Woods Creates a Comfortable Environment for Quality Management: Establishing and enforcing document management and control processes has improved their manufacturing and production processes, enhanced collaboration internally and with their suppliers, and driven organizational efficiencies that have had a major impact on their bottom-line objectives. 06

7 ISO 9001 Certification 07 Other documented EIM deployments highlight examples of potential benefits that can be gained on the path towards ISO certification: Less time spent looking for ISO 9001 documents. All ISO 9001-related content can be tagged with metadata attributes that identify them as ISO 9001 related as they are created or saved. These metadata attributes allow documents to be retrieved based on context and relevance instead of on which folder they reside in. The added layer of intelligence makes it quick and easy to locate relevant ISO 9001 information, or to retrieve related documents for any other purpose or project. Better visibility of ISO assets. Digital content can be managed as part of a single virtual repository, eliminating silos of information that are time consuming to search. Automated version control and archiving. Employees can access the most current information, or retrieve historical documents. Streamline ISO certification tasks. ISO 9001 certification-related workflows can be automated, with the enterprise information management solution giving managers complete visibility of process status. esigning capabilities can further automate workflows for certification-related processes. Protect sensitive and valuable content. Access management features ensure the security of confidential or mission-critical information. The main advantages of ISO 9001 remain the same 55 years after the original guidelines were drafted certification gives partners and customers the assurance that the company they re working with has strict processes for ensuring its quality policies are followed throughout the organization and that they ve embraced the concept of quality through continual improvement. Today, instead of questioning whether to embark upon ISO certification, it might be better to ask, Why not? ECM EIM ENGINE PROPELS QUALITY, EFFICIENCY AND PRODUCTIVITY Take advantage of the ISO 9001 certification process to raise awareness about these types of benefits that can be gained from an enterprise information management solution. Besides driving up efficiency and productivity, every business should consider how improving quality can strengthen the company s reputation and help to avoid risks. Best-in-class EIM solutions can further strengthen a company s position in the market by extracting more value from information and turning it into competitive advantages.

8 Workflow 08 WORKFLOW HOW CAN MANUFACTURERS KEEP THEIR DOCUMENTS UNDER CONTROL? One of the most essential tasks for manufacturers is maintaining compliance with industry standards and regulations, which entails managing large amounts of sensitive information. This can be a big job and many firms are falling short with the document control requirements associated with quality standards such as ISO 9001, according to an article in Quality Magazine. The issue is often exacerbated by the fact that quality managers can face difficulties in convincing senior management that implementing a document control solution is a critical component of a manufacturer s ability to adhere to standards and regulations. In the past, it was often the case that document management consisted of little more than keeping physical copies of confidential files in locked cabinets, to which only certain personnel had access to. However, manual, paper-based processes often lead to lost data and incorrect versions of documents being utilized, making it difficult to ensure authorized personnel have up-to-date information about the state of quality documentation and processes.

9 Workflow 09 CONTENT IN CHAOS When diverse and disconnected filing cabinets, network files, folders and other systems are used to store data, it is almost impossible to get accurate details quickly. Information is also often unnecessarily duplicated, causing an extra layer of work as personnel sort through vast amounts of data to find the correct version. As a result, quality managers in manufacturing firms are often unsure as to how key processes are being followed and if issues have been resolved. A document management solution integrated within a quality management framework enables manufacturers to consolidate important operational information into a simple, easy to search platform that allows users to locate and view the most accurate data at the exact moment they need it, without having to hunt down paper documents that can reside in multiple physical locations or are buried within a complex network folder scheme. Good manufacturing practices require firms to keep tight control over their documents to manage file versions, control employee access and implement changes swiftly. When documents can be searched, viewed and edited across integrated systems, workflow processes are significantly streamlined and operational efficiency is greatly improved.

10 GMP and Documentation 10 GMP AND DOCUMENTATION 5 BEST PRACTICES Good Manufacturing Practices (GMP) include all of the methods, equipment, facilities and controls necessary to produce high-quality products. Formal GMPs are published guidelines for regulated industries such as pharmaceuticals and processed foods, but informal GMPs encompass a much broader set of best practices that continually evolve. In the pharmaceutical industry, for example, the regulation-based practices are referred to as current GMPs or cgmps to emphasize the dynamic nature of the guidelines. Companies adhere to GMP because they provide customers and partners with confidence and assurance that they follow common industry practices for ensuring quality in the manufacturing process. However, GMPs inevitably require manufacturers to produce and manage a massive amount of information. Quality management teams often feel buried under mountains of inspection sheets, audit reports, nonconformance documents, corrective and preventative actions (CAPA), customer inquiries, and more.

11 GMP and Documentation 11 ARE YOUR QUALITY AND COMPLIANCE DOCUMENTS IN AN ARCHAIC ARCHIVE? For companies that still rely on predominantly manual information management processes, the signs of strain can include lost quality and compliance-related documentation, missed deadlines, cross-department inefficiencies and miscommunications not to mention unsatisfactory audits and non-compliance with industry regulations. The first sign of trouble for many companies often stems from archaic processes for storing and organizing critical quality management documents, which can then result in manufacturing and production mistakes, non-compliance issues and customer complaints. RED FLAGS INFORMATION AND PROCESS MANAGEMENT ISSUES THAT IMPEDE GMPS To gain better understanding about the sources of suspected quality management issues that can negatively impact the ability to adhere to GMP, start asking the following questions: Gatekeepers: Is there one person that manages most or all essential quality-related documentation? What happens if a critical person is sick, on vacation, or leaves the company? Status inquiries: Can you get quick answers to critical quality questions (E.g., Have the required people read the new instructions or completed the latest training?)? Issue resolution: Are manufacturing and quality-related issues quickly addressed? Is information routed efficiently? How long does it typically take to get required signatures at each milestone? Errors: How many manufacturing errors and deviations are the result of lost or misfiled quality files or records? What is the cost related to lost or misfiled information? Labor costs: How much staff time is spent compiling and organizing quality and compliance-related documentation? How many hours are spent manually routing and tracking documents, obtaining approvals, and locating any requested compliance information? Armed with an understanding about the major problem areas affecting the ability to adhere to GMP, specific steps and actions can be taken to improve information and process management practices and approaches.

12 GMP and Documentation 12 BEST PRACTICE #1: ALIGN DOCUMENT & QUALITY MANAGEMENT Documents are critical components at every phase in the manufacturing lifecycle. Are there multiple repositories of quality-related information? How easy is it for quality teams to quickly locate information? By leveraging an enterprise information management (EIM) solution that can connect information silos, manufacturing companies can make it fast and easy for staff to retrieve the most current and accurate quality and compliancerelated information. BEST PRACTICE #2: REVIEW GMP CONTENT ORGANIZATION Many quality-related problems stem from inconsistent categories and subcategories for organizing GMP-related content. Review and revise company-wide definitions and organization constructs, with an emphasis on intuitive and well understood categories that match organization roles and product phases (product design/ development, quality control, merchandising, service, customer feedback, management, etc.). EIM platforms can simplify content classification and re-classification efforts by leveraging a more intelligent scheme for organizing quality management content. Metadata attributes serve as labels that describe each information asset and allow a single file to be stored once but accessible via in any number of dynamic views without duplication of content. BEST PRACTICE #3: SIMPLIFY QUALITY PROCESSES AND WORKFLOWS Besides making it easier to store and retrieve quality-related content, metadata-driven EIM facilitates the automation of tasks and assignments as well as for processing documents that require the approval of one or more individuals. For example, the review and approval process for a new version of a Standard Operating Procedure (SOP) can be implemented in an EIM solution as a metadata-based workflow. A single copy of the SOP can be routed among team members to avoid duplication of content. In addition, automatic notifications can be set up in an EIM system, for example, to verify that shop-floor staff have re-calibrated manufacturing equipment before each new production run. BEST PRACTICE #4: IMPROVE VISIBILITY AND CONTROL Simplified, automated procedures still require oversight and accountability, which is further incentive for integrating information management with an organization s quality management framework. Managers need to be able to monitor critical documents as well as workflow status relating to those documents and other important quality-related tasks. When processes change, management needs to be able to verify that the appropriate people have reviewed SOPs and other documentation outlining the new procedures and processes. EIM systems provide an audit log that enable management teams to track vital quality management processes. BEST PRACTICE #5: ELECTRONIC SIGNATURES When it is time to approve or authorize documents, even digital content is most often handled in hard-copy form with handwritten signatures. While legally binding and psychologically comfortable, signing documents with a pen can hold companies back. The paper-based signature issues include a lack of file control, degraded productivity, and the need for ever-increasing space for paper document storage. Larger companies must also deal with shipping papers between offices, and every paper-based business risks losing vital documents in the event of a natural disaster, fire or some other catastrophic incident. Many companies are leveraging electronic signatures to accelerate their adoption of paperless processes. Today, there are affordable and secure solutions available that comply with FDA and GMP guidelines for electronic signatures.

13 What is Big Data Today? 13 Since the term was first coined, big data has left an imprint on nearly every industry and has become a fundamental consideration in the development and deployment of many enterprise applications. In life sciences, research and development teams increasingly rely on big data analytics to better correlate research results and predict drug responses, interactions, and outcomes. WHAT IS BIG DATA TODAY? BIGGER CHALLENGES FOR BIG DATA IN LIFE SCIENCES Big data often looks and acts differently depending on the industry, and in the life sciences sector, it often refers to massive volumes of structured data residing in database applications. In addition, research teams are deluged with massive volumes of unstructured content such as research documents, raw instrument data files, image files, patient studies, and other diverse information that must be meticulously managed in order to discover correlations that ultimately refine drug therapies and optimize patient outcomes. Researchers today also have the opportunity and associated challenges of a larger and very collaborative community. With more data sources and external partners, big data tools are being adopted to more effectively manage and harness the diversity of research data and to enhance mission-critical and strategic collaborative initiatives.

14 What is Big Data Today? 14 BIGGER, MORE COMPLEX DATA The big data goal is still the same: extract actionable intelligence that can yield high-level business value. However, the greatly expanded scale and diversity of life sciences data poses even bigger challenges today. In its publication, Hype Cycle for Life Sciences, 2014, Gartner reports that life sciences R&D teams are currently focused on three distinct big data challenges: Quantification dealing with data volume, as well as increasing data velocity (the rate of incoming data, which requires faster data and content processing) and the diversity and complexity of big data (multiple formats, types, and sources). Access enablement and control being able to classify information for controlling access; establish rules and employ technology that can speed secure access, searches, and workflows. Qualification and assurance maintaining accurate information (data fidelity), validating and linking diverse data sources and categories, and managing data perishability (versions and archiving). ENTERPRISE INFORMATION MANAGEMENT FOR THE BIG DATA WORLD Harnessing big data calls for enterprise information management (EIM) solutions designed to address all of these dimensions of the challenge. As a foundation for effectively leveraging big data, an EIM platform offers improved capabilities for collecting data and content, analyzing comprehensive information assets, storing information, and reporting information status, access behaviors, and other activity of interest to IT and researchers. With built-in intelligence, the best-in-class platforms can also provide the foundations for: Compliant and consistent product quality Improved security for sensitive assets Automated workflows, for easier oversight and process efficiency Faster dissemination of updated information (and confirmation of uptake) The right enterprise information management solution can provide these capabilities in a manner that makes it possible to leverage and integrate many diverse information sources. By facilitating the integration of complex and varied structured data together with all of the various formats of unstructured content, researchers and other teams faced with big data challenges can maximize extracted value in the form of information insights. This approach also solves the other workflow and access challenges associated with otherwise siloed information repositories, and fosters the development of automation that spans multiple systems and processes. Yes, big data means even bigger challenges today. Fortunately, EIM approaches have evolved in tandem with big data. This is a very good thing, because life sciences R&D teams are just one segment of a growing field of big data pioneers. And with many common goals, such as faster time to insight and increased value to the business, consumers of big data can look forward to the advancements being developed to meet these needs and the corresponding benefits that include accelerated time to market, improved supplier relationships, better customer service, and more.

15 About M-Files 15 M-FILES CORPORATION ABOUT M-FILES M-Files enterprise information management (EIM) solutions eliminate information silos and provide quick and easy access to the right content from any core business system and device. M-Files achieves higher levels of user adoption resulting in faster ROI with a uniquely intuitive approach to EIM that is based on managing information by what it is versus where it s stored. With flexible on-premises, cloud and hybrid deployment options, M-Files places the power of EIM in the hands of the business user and reduces demands on IT by enabling those closest to the business need to access and control content based on their requirements. Thousands of organizations in over 100 countries use the M-Files EIM system as a single platform for managing front office and back office business operations, which improves productivity and quality while ensuring compliance with industry regulations and standards, including companies such as SAS, OMV and NBC Universal. For more information, visit New Go To Home Assigned to Me Checked Out to Me Favorites Recently Accessed by Me Assignment: Intake Form Update Website images Assignment: Blog Post Assignment: Intake Form - Standard Graphics Request_partner Assignment Created 03/17/16 Class* Assginment (General) Name or Title*