An Effective Records Management Program in Life Sciences Organizations is Essential to Compliance
Wed, 08/20/2008 - 9:25am
Regulated content is not the only content that has to managed to ensure complianceBy Therese Harris, Program Manager, Life Science Initiatives, Open Text Corporation
There has been a lot of confusion about eDiscovery and how a record is defined in the life sciences industry – some organizations believe that regulated content is the only content that has to have record classifications applied to it, which isn’t the case. Additionally, because of the litigation aspects associated with these records, legal counsel and the senior executives bring their own perspectives.
Pharmaceutical, biotechnology and medical device manufacturers face a vast amount of legislation and regulation which guides their records management practices. Records Management is nothing new to this industry, but the increasing use of technology in the industry, and the increasing use of electronic information management, is forcing organizations to rethink the way they manage their records.
Organizations need to recognize that a solid enterprise-wide records management practice is essential to a successful compliance program. Many organizations have implemented departmental strategies to address one or more records management requirements typically under the regulatory or quality management umbrella, but recent changes in eDiscovery legislation as well as general good corporate governance practices require a holistic approach to records management.
21 CFR Part 11 - What is a Record?Under the FDA Rule: Title 21 Code of Federal Regulations Part 11 for Electronic Records and Electronic Signatures a record is defined by the predicate rules, which are any requirements defined in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation, such as GxP, GLP, GMP, GCP, etc. The predicate rules mandate what records must be maintained; the content of records; whether signatures are required; how long records must be maintained, etc. If there is no FDA requirement that a particular record be created or retained, then 21 CFR Part 11 most likely does not apply to the record.
21 CFR Part 11 provides the criteria under which the FDA will consider electronic records equivalent to paper records, and electronic signatures equivalent to hand-written signatures.
According to the Rule, organizations need to ensure the authenticity, integrity, confidentiality of electronic records. Organizations need to be able to generate accurate and complete copies of records in both human readable and electronic form; and they need to ensure the protection of records in order to make the accurate versions readily available throughout the records’ retention period.
The FDA recognizes that the use of electronic records increases the speed of information exchange, reduces errors, helps with data integration and reporting, improves process control, allows for the economical collection of data, and enables accessibility. As an example - in the case of Investigational New Drug Applications, records include Case Report Forms and other supporting data and information. Regulations require the adequate and accurate preparation and maintenance of clinical trial records, and require regulators be permitted access to verified records and reports; If the records are in electronic form then 21 CFR Part 11 applies.
Federal Rules of Civil ProcedureIn 2006, the United States of America Supreme Court approved amendments to the Federal Rules of Civil Procedure concerning the discovery of electronically stored information. The amendments acknowledge that electronically stored information is discoverable and is meant to include any type of information that can be stored electronically, both now and in the future.
Most major pharmaceutical companies are involved in dozens of litigation proceedings at any one time. So the issue of discovery for a pharmaceutical company is big. Until now the policy of most organizations has been to keep everything, but with the new discovery rules, organizations realize they would need to spend significant resources reviewing electronic documents before handing them over, so a modification of the ‘keep everything’ policy is in order.
Although technology tools can help reduce the volume of information returned in an electronic search, an analysis of the information still needs to be performed on relevant information before submitting it to the discovery process. Therefore, in the interest of both time and money (i.e. human resources), organizations need to pursue an eDiscovery strategy that will deliver only relevant information quickly in a search, and perform periodic and timely elimination of any non-relevant information by disposing records that are not required to be kept in accordance with the RM policies.
As mentioned, the amendments to the eDiscovery legislation broaden the process to cover all content types, including the traditional documents, memos, and spreadsheets, but also cover emails and emerging forms of new media. One of the struggles with an enterprise records management deployment has been to bring all content together under a single records classification schema. Some enterprise content management vendors are addressing that very need today by providing integration to a variety of content repositories including Microsoft Outlook, Microsoft Office SharePoint Server, and file servers.
Taking a Deeper Look Into Records ManagementRecords management technology empowers everyone in your organization to classify all corporate holdings according to organizational policies, managing the complete lifecycle of all corporate records, thereby ensuring regulatory compliance and reducing the risks associated with audit and litigation.
Some vendors offer a Web-based records management interface enabling all users to access records management functions from a standard Web browser. By providing a common interface to access all forms of information, such as images, paper, word processing documents, spreadsheets, and email, records management tools provide an automated system that removes the complexities of electronic records management, making the process completely transparent to your end users.
By classifying enterprise content as business records, you are also identifying the business context and value of corporate information. Accordingly, the entire records management process gives organizations a much clearer understanding of what their enterprise content represents. And as such, they can much more easily extract its maximum value; in other words, make the most of that content. Records management improves access to enterprise records, giving all users the ability to capture, create, classify, manage, and retrieve physical and electronic content.
What Makes Records Management Different from Document ManagementRecords management is embedded into an enterprise content management system and extends document management by adding Classification, Records Detail, Hold, Label, Preservation, Retention, Disposition and Cross Reference capabilities to ECM documents, folders, email, compound documents, and physical objects functionality.
Records management capabilities map record classifications to retention schedules, which fully automates the process of ensuring that records are kept as long as legally required, and assuredly destroyed when that time elapses. When a retention schedule expires, final decisions can be made to destroy the object, retain it for a period of time, or keep it indefinitely.
Report generation tools assist organizations by creating full and detailed listings of records that are ready for review or final disposition. The listings can then be routed to appropriate individuals for review and approval. Disposition searching supports disposition searching against ECM items, which calculates the disposition date of the items returns those records that are ready for deletion, archiving, or moving on to the next stage in their lifecycle.
Records management tools support the application of multiple file classifications and retention schedules to individual records concurrently, meaning that a document can hold two or more record classifications and be retained concurrently according to multiple retention schedules. With records management in place, users can also automate the disposition of records according to organizational requirements; for example, if your organization is managing thousands of emails as business records; the sheer volume of this content demands automated management processes.
In the event of litigation, it is imperative that organizations secure potential evidence from destruction. Vital record identification supports vital record identification and the cycling of vital records based on pre-set periods such as monthly, quarterly, and annually. Official record designation is used to ensure enterprise-wide integrity of all business-critical knowledge by marking documents as official, thus preventing users from modifying the information in any way. Legal holds can be applied to suspend retention schedules and protect records from deletion. Multiple legal holds can be applied to documents at the same time.
One benefit to implementing a records management system is that the management of physical content can occur alongside electronic documents. Common requirements such as circulation, requesting, boxing, and printing color coded labels are all supported. A warehouse management feature can be used for boxed items transfers, and space management to internal or offsite storage facilities. ?Records management tools extend records management initiatives across all corporate information repositories. Fully-integrated archiving enables the long-term storage of records in a compliant storage environment. The stages in a records lifecycle or changes in the record’s status can be used to automatically migrate it to different storage areas.
The Future of Records ManagementLife sciences organizations are now just beginning to feel the pressure of managing their documents effectively. Down the road, the volume of information is going to be much more significant than 10 years ago so to be properly prepared, putting a records management program in place now is more imperative than ever. Working with the vendors in the space is key that so organizations can be assured they have the technology to support them as part of their long-term strategy.
Life sciences organizations need to have structure around their records and consistent rules around their records management. Transparency is also crucial. A consistent records management program across the entire enterprise is needed to support the organization.
About the Author:
Therese Harris, Program Manager for Life Sciences at Open Text, is responsible for vertical market applications, key industry partnerships, and marketing specific to Life Sciences. She has over 15 years experience in the enterprise software industry with special focuses on collaboration, communication and compliance solutions. Therese has spent the past six years in the Enterprise Content Management market and has written and lectured on the application of ECM in vertical markets such as Life Sciences, Financial Services, and Government.