Practical Electronic Records Management Articles


7 Core Capabilities for a Next Generation Records Management System

How much content does your organization store? I bet it’s a lot. Content from customer interactions, content from product and services, content from internal processes, partners, suppliers, stores – the list goes on and on. Recent research shows that by 2020 the world’s data will grow to 50 ZB from 10 ZB in 2010. Now that’s not all your information, but you have plenty to look after. And that’s why you need a next generation records management system.

Think about all the content you have in business systems. There are a lot of records there to manage. Now think about all the content you have stored in file shares, Google Drives, Office 365 and other repositories – you need to manage the content in these repositories as well. You need some type of records management solution to help you manage this information. But not all records management systems are alike. Some are so complex to use that only a few people use them and even fewer records get managed by them.

With the help of our partner, Flatirons Jouve, we’ve identified seven core capabilities for an agile, next-generation records management solution. Here they are:

1. Connectors for Real-time Data Ingestion

You need a way to easily connect to all the business systems and repositories where you manage information. You want a solution that can connect in real-time, at the point of record creation (or when a trigger occurs) and either pull those records into the Records Management System, or manage them in-place.

2. File Analysis

Not every piece of information is a record. You need a way to analyze all the information in your systems and figure out what is a record to manage. File analytics tells you what you have and where it’s located. It also helps you determine what is ROT (redundant, trivial and obsolete) so you can dispose of it, what is personally identifiable information and needs proper records management.

3. Ingest Records or Manage Them In Place

The reality is that you won’t want to store records solely in your records management system. Some you will manage centrally, others you will want to leave in the systems where you created them for different reasons. The records management system you use should provide the ability to do both giving you a central place to manage the records, regardless of where they reside, and a central location (single pane of glass) to search for the records you need.

4. Automatic Classification

You can try to force your employees to classify your information manually. Some will do it, some will do it right, and others will not have the time or patience to do it at all. The right records management solution will provide the ability to analyze and automatically classify your records according to a defined taxonomy and metadata rules.

5. One Place to Search for Records

It takes time to search through multiple systems to find the records you need. Time you may not have. And what if you miss something? These are challenges you can avoid with a records management system that can connect to multiple systems via federated search (and secure search by the way).

6. Apply Complex Retention Rules

Rules are rarely straightforward and simple. Conflicting regulatory requirements, changing business objectives and other factors can make retention rules complex. Your records management solution must be able to understand and apply complex retention rules automatically. And that includes being able to change the rules after a record is created to reflect changes in compliance rules and other decisions.

7. Automatic Disposition Tasks

You may want an administrator to review records that have reached the end of their retention period, but then you want a system that will automatically apply the disposition rules. That may be moving a record to an archive or triggering the final disposition (destruction) of the records. This part of the records management process should not be manual and open to mistakes.

There you have them – seven core capabilities of a modern, next generation records management system – each one an important capability in today’s ever-changing world.

Want to learn more? Download the whitepaper: How to Simplify Complex Records Management in Compliance-Driven Organizations.

Documentum and Everteam Integration: A Better Records Management Experience

The following is a guest post from TSG Group that takes a look at a new connector Everteam and TSG built to provide records management for Documentum content. Enjoy!

TSG has recently partnered with Everteam to build a connector that will allow easy management of records in Documentum using Everteam’s Archiving and Records Management solution everteam.records. In our de-risking Documentum RPS blog we highlight several of the complexities in using Documentum RPS and how we suggest simplifying them. While RPS is a full-featured solution, its aging admin interface, rigid configuration rules, and the audit trail bloat has proved challenging for our clients. Combine concerns about Documentum RPS with the uncertainty surrounding Documentum at OpenText and OpenText having a competitive Records Management product, many clients are looking for a third party as a more reliable alternative.  With the new integration, Everteam’s modern architecture and user interface eases the deployment of an end-to-end records management solution into a Documentum repository.

Limitations of Documentum RPS – In-Place and Individual Documents

Currently, Documentum’s RPS functionality for dynamic in-place records declaration does not exist. Retention policies are applied either to a folder or to individual records within a folder. RPS cannot be configured to evaluate individual document metadata and apply retention policies. The Everteam connector solves the individual document and in-place problems. Everteam evaluates the metadata on each individual document and matches it to a record type specified in everteam.records. Once matched, a record is created in Everteam and the record-id assigned as a property to the document in Documentum.

From Everteam’s website, “Everteam.records can capture, manage, and provide access to all the records in your organization. The result is one repository with a single point of entry to search all your records, whether they are in a database, files on a shared drive, documents in your content management system, messages in your mail system, or even paper files in boxes.”

Everteam.records provides the functionality to replace Documentum RPS as well as add additional capabilities to be a records hub for additional systems and databases. Record metadata can be exposed and analyzed performing full analytics using

Everteam Records Management Solution Background

Similar to the three Documentum Records Management modules, RPS (retention policy services), RM (records manager), and PRM (physical records management), Everteam.records manages electronic and physical records. Everteam’s physical records management features are extensive including storage management, arranging transfers and reserving space, as well as records requests and outsourcing their management.  Everteam’s electronic records management capabilities are even more extensive. A record can not only be a document but also a collection of data in a database. Everteam has configurable connectors for importing data from multiple source locations allowing Everteam to consistently manage record retention, disposition, and transfers across multiple systems. The Everteam connector feature is ideal for importing records from legacy systems scheduled for retirement.  For example, if a Documentum system is slated for retirement, the records can be fully ingested into Everteam for archiving.

In Everteam, the Records Manager has full control of configuration.  As an administrator of the system, the Records Manager defines record types, relates them to departments, and then associates the users with roles and to departments so they can access their records. Additional tasks include defining authorizations, specifying storage locations, configuring the file plan, and reporting statistics.

Using Everteam to manage records in-place in Documentum allows users to continue using the system they are accustomed to for daily document management. It also allows Records Managers to automate the record life cycle and have the users hands-off in declaring records. If records require periodic review or review and approval prior to disposition or transfer, Everteam’s workflow is used to notify users and perform the required tasks. Users can view a collection of records and update records for review or approve disposal lists. It is also possible to disposition or transfer records without any user approval.

Documentum Records Management Example

In the video below we’ve connected to a Documentum repository using Webtop where we’ll navigate to records in the repository that require archiving. The Everteam Documentum Connector is configured to identify records by querying for documents with a status set to Pending Archival. When it runs it will create a record in Everteam that is associated with the document in Documentum. In Documentum, the Connector will update the document status and set the Everteam record id as a metadata value. The document is now a managed record.

When a record is linked from Documentum to Everteam, the Everteam Documentum Connector automatically assigns it to a specific record type with a retention schedule. This allows for Everteam to manage the record and apply the a specific disposition schedule to it. Finally, when the record is eligible for disposition at the end of its retention period, the Everteam Documentum Connector will delete it from the Documentum repository.

Want to learn more? Send us a quick message. We would love to chat.

Key Records Management Considerations During a Life Sciences Merger or Acquisition

Mergers and acquisitions occur regularly. In fact, 30% of world’s largest organizations are considering some merger or acquisition. The life sciences industry, in particular is characterized by frequent merger and acquisition activity.  In addition to mergers between large companies –think Pfizer-Allergan – smaller, early stage pharma and biotech companies are often purchased as their R&D efforts yield new drugs ready to go to market.

But the reality is that mergers and acquisitions are difficult to execute. There’s a lot that needs to happen with a merger/acquisition, not the least of which is combining and rationalizing IT systems. The need to carefully reconcile systems is especially critical for life sciences M&As because each company typically has a wide range of systems, from quality systems to LIMs systems to systems for managing clinical trial and drug application documents.

Records Management (RM) is a critical consideration during M&A activity, because as systems are combined or decommissioned, the records need to live on and be accessible and managed according to regulatory requirements.  By designing a RM strategy and solution that is effective, financially viable, and adheres to industry regulations before any M&A activity emerges, companies can make themselves not just more attractive, but more valuable.

Managing Records Across Systems

Every company has multiple business systems, with content and documents spread out across the organization. This makes information hard to manage and hard to find, and creates risks associated with applying regulatory processes consistently across disparate systems.

Consider, for example, the types of document-based systems that a typical life sciences company uses. They probably have a quality system for managing SOPs, and a systems for managing R&D activities such as a LIMS system and a system for managing lab notebooks. They almost certainly have an “eTMF” system for managing clinical trial documents and processes, and they may have a system for managing eCTD documents related to drug applications. And that is just the start of the list.

All these different systems spread out across the company cause challenges for records management. For example, a company must be able to find and deliver and preserve any document on a particular topic within a reasonable amount time in case there’s a subpoena requesting information about it.

Companies are also required to manage documents with a retention policy that is logical and consistent across all systems (for example, all documents of a certain type or family). With documents spread across many different systems, consistent application of retention policies can be a significant challenge.

A great RM system doesn’t replace all these different systems. Instead, it sits off to the side and keeps track of all the documents in all those systems, ingesting some and creating an index to others but leaving them in the systems from which they originated. This provides the ability to search across systems, place documents on hold, and manage retention policies for all records no matter what system they are in.

With a unified records strategy and solution, you can easily meet regulatory requirements without upending all the different systems you have. It also makes dealing with records in an M&A situation far simpler, since systems can be decommissioned or merged as necessary while retaining the records outside the source systems.

Dealing with Records When Moving to New Systems

Here’s a scenario that highlights the benefit of having a records management solution in place when moving to a new system.

You work for a large pharmaceutical company. One of the systems you manage is a Documentum system which stores your quality records, such as your SOPs (standard operating procedures), some old, some new. You want to move to a new system for managing these records, one that is new, better, faster and cheaper. Do you move all your records, both old and new? How do you move the old records and still ensure the regulatory requirements, such as audit records, are maintained? Do you keep the current system for the old records and use the new system for new records?

If you decide to keep the old system for the old records, then you have costs associated with two systems, two different places to find information, and so on. This is clearly not ideal.

A unified records management system provides a better solution. In this case, it can take the old records out of one system (ingest them) and store them in a standard format (such as PDF) with all the information they need, like the audit trail and versions. New SOPs are created and live in the new systems, but the SOPs created by the system being decommissioned remain available, searchable and are managed in accordance with consistent retention policies.

Now put yourself in the position of managing a merger or acquisition; a company with a records management solution in place makes a much more attractive candidate than one that has not made that investment.

What this Means for a Merger or Acquisition

In an ideal merger or acquisition scenario, both companies use the same business systems, the same records management systems, and have the same records management processes.

But of course that scenario doesn’t exist in the real world. In a merger or acquisition, there will always be duplicate systems doing the same function, but from different vendors and built on different platforms.

For example, one company may use Documentum for its SOPs and the other uses Veeva. Once merged, however, they only want to use Veeva. The question then becomes how do you merge the Documentum records into Veeva?

You basically have three options:

  1. Migrate everything from one system to the other – a very expensive and time consuming effort.
  2. Leave the old inactive records in Documentum and go back to it when you need them, even though there are costs associated with keeping a system operational (think upgrades!) just to access inactive records.
  3. Move the old Documentum records to a separate records management solution, migrate just the active records and use the new system for all new records.

The third option is clearly optimal. But it begs the question: How is this third party generic system cheaper or better? You still have to move all your records. Aren’t you simply moving from one proprietary system to another?

The answer is to look for key capabilities in the unified records management system. Here is a short list of requirements for a unified records management solution:

  • Records are stored in a non-proprietary format (a PDF which stores all the metadata like audit trail and version information with the PDF)
  • Can ingest or index records in other systems
  • Can search records whether ingested or indexed
  • Is able to take actions on records – such as legal hold
  • Applies retention schedules and triggers actions based on those schedules
  • Provides “tiered stirage” – the ability to move records with different access requirements to different storage technologies
  • Makes it easy to migrate them again if you needed to move them
  • Is CMIS (content management interoperability standard) compatible (an open standard that enables different document management systems to talk to each other)

Additional Challenges Life Science Companies Face with M&A

Life sciences is the most regulated industry other than nuclear in the United States, and as such mergers and acquisitions face challenges similar business transactions in other industries do not. 

  • Regulatory Requirements: We’ve already mentioned the regulatory challenges companies in the life sciences face. Everything from SOPs to clinical trial documents and processes must be carefully managed and stored to meet strict guidelines and laws.
  • Multiple Disparate Systems: Life sciences companies with revenues of over $100 million typically deal with at least seven or eight types of technology to manage records and documents. Some of these are custom built on platforms such as Documentum. Others are best of breed solutions that solve specific problems. And most of these companies do not have a global centralized records management architecture.
  • M&A Patterns in Life Sciences: In the overwhelming number of cases of M&A in life sciences, big buys small. What the mid-size company needs to be aware of, however, is how their approach to records management and regulatory compliance can make them more – or less – attractive and acquirable. 

Proper Records Management is Critical

Combining companies involves unifying systems and processes of many types. Records management is only one area that needs close attention — but is an area that can affect lots of other areas relating to IT strategy, flexibility and costs, as well as regulatory compliance risk.

For the life sciences industry, the amount of regulation and the vast quantity of records created means that integrating systems involves challenges relating to the migration, retention, and management of records. That means that whether you expect to be an acquirer or an acquisition target, creating a unified records management strategy and system can make the prospect of a merger far less daunting.

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