For Pharmaceuticals and Biotechnology:

Status Means More than Prestige in Lifecycle Management
by Lane Hirning, MasterControl's Product Manager and Pharmaceutical Industry Expert


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Lifecycles are normal states of nature. Plants, animals, and all manner of things are born, live useful lives and die.

Documents have lifecycles, too. They are created, used, stored (and hopefully not lost!) and archived or discarded. Stone tablets, papyrus, animal skins, and paper have all been used to construct and manage what their originators believed to be valuable data.

We can share data with peers, modify it, cut it and paste it, save it and ultimately archive it when the letters and numbers have outlasted their usefulness.

Technology has taken this idea of document lifecycles and improved on it. Where we once had to hand-carry physical data recordings from place to place, we now send it electronically from one location to the next. We can share data with peers, modify it, cut it and paste it, save it and ultimately archive it when the letters and numbers have outlasted their usefulness. This process holds true whether the company is in its infancy, experiencing rapid growth or is an established name in the industry.

As a company grows in size, the number and complexity of its documents usually increases until the business outgrows its file share system. At this point, most companies move to a document management systems (DMS).

Working within a DMS offers a number of advantages over paper documentation:

  • Version control
  • Electronic signatures
  • Enhanced document security
  • Automatic generation of PDF
  • Templates for creation of new documents
  • Document lifecycle management

The most important advantage is document lifecycle management.

The lifecycle of a document is designed as a series of linked steps, or statuses, that begin with creation of a document and follow it through multiple steps until the document is no longer needed or pertinent.

The statuses are usually associated with a change in the access control list or permissions accorded to different users, allowing them to read or edit the document. Movement between these steps is usually controlled by dates (effective date, expiration date, review date) or user actions (approval or rejection during a workflow).

Status movement can also occur as a result of a combination of dates and actions. For example, if a reviewer approves a document by a certain date, it can move to an approved status; otherwise it is escalated to someone else for approval. In another case, a document may be approved but it does not reach the "Released" status until the training is completed on the designed date.

Lifecycle Steps

The first step in the lifecycle process set at the creation of the document is usually known as the draft status. Status changes most often occur as the document goes through the lifecycle with version sequences along the way.

Different companies have different lifecycles standards and status steps in the lifecycle. The names and meanings of the status steps can vary from system to system and between types of documents. Examples include:

  • Draft, Released and Archived
  • Draft, Reviewed, Approved and Archived
  • Draft, Final, Approved, Obsolete, and Superseded

Just as status steps can be simple or complex, the way they are linked in a lifecycle can be varied. Logical linking is related to good project planning; there is no sense in moving a document to a new status if the project plan is a mess!

There are several ways a document status can be linked in a lifecycle. Linear linking is a straight line process where a document is created, released and archived. It's the simplest form of a document lifecycle.

Looping involves moving the document from an intermediate stage back to the draft stage in the case that a document is rejected at the intermediate step.

A document can jump forward to a new status when a document is 'expired' or 'archived' prior to the final approval moving the document to the obsolete or Archived status, skipping the approved status.

Branching is another status step for a document. Branching allows linking of the lifecycles such that a document can move into a second lifecycle based on an action or date where the document might be deprecated or moved into the other lifecycle based on a business decision.


Figure 1.

Actions within a Document Status

As a document proceeds from one status to another, any number of people may need to provide input on it. The DMS controls how changes are made within each status to prevent the appearance of costly errors.

For instance, say a document is created in the DMS by a quality control team member. The document is sent on a workflow within the DMS to begin the review process. Within that review process are a number of workflow steps that take place while the document is locked away from the general employee population. These workflow steps can include project team collaboration where the document is redlined and commented on at a team level, intermediate document approval after the redlines are consolidated and finally full document approval with a status change.

Because the DMS controls who is able to see the document at all times, unauthorized personnel are not able to enter the collaboration space and view or alter content. This is important as the document content is in flux and a 'rogue' copy with unapproved modifications or comments could be circulated, creating problems both social and possibly legal. As the document exits the collaboration and the changes are approved, it may proceed through several more verifiable versions before changing statuses. This is important evidence during an audit.

Documents are linked through status progression but they can also be linked through document lifecycles. For example, once a document completes its progression through the research and development lifecycle, it moves on for management review and must travel through the managerial lifecycle. Once management has released the document, it can become available for general use.

Figure 2.

Significance of Document Lifecycle for Regulatory Submissions

Why is this progression so important? Because within the document lifecycle, there will be a lifecycle status designated as the status that a document must reach to be 'official' and distributable within the company. Similarly, in a pharmaceutical company, a single status needs to be designated as the status used for gathering submission documents for FDA drug approval. This may be the same as the normal 'approved' status or may be different.

The submission tools inside a company's DMS need to be able to distinguish the approved final documents from draft-status documents. This is another reason an orderly progression with appropriate sign-off (most often, an electronic signature) is a critical component of the lifecycle process.

When a document reaches submission status, it should:

  • Be rendered as a PDF, meeting Agency requirements
  • Contain appropriate bookmarks
  • Contain hyperlinked tables of contents, when applicable
  • Feature E-signature manifests, if appropriate

A document reaching submission status should NOT have:

  • Watermarks
  • Expiration dates
  • Passwords, macros, etc.

Exiting the Document Lifecycle

At the status designated for submissions documents, the document lifecycle and the publishing lifecycle intersect. The documents prepared for submission exit the DMS lifecycle and begin a submission lifecycle. These documents are rarely revised outside of the DMS, other than for final packaging for regulatory submission. This repurposing of the documents for submission includes the creation of hyperlinks to other documents in the submissions, standardization of the bookmarks, hyperlinks and other reference marks. Ensuring that the documents stay consistent in the submission is the key here but rarely will these documents be re-submitted to the DMS - they are now part of the submission lifecycle.

Summary

We've been managing documents of different kinds for as long as written communication has existed. Technology now enables us to electronically control the flow of documents and the idea of lifecycle status is essential to good document management. Status is connected with the idea of a permission-based control system that allows for electronic sign-off through levels of review. Lifecycles can be simple, containing only a few statuses, or complex. Within a status, documents can be placed in collaborations, reviews or approval workflows that lock the document away from the general employee population, preventing any kind of interference. Finally, lifecycles can be linear, looped, branched or linked to create very complicated workflows. Good lifecycle management ultimately creates a solid document repository that a company can use for regulatory submissions, customer audits or to provide reliable documentation for manufacturing processes.

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Lane Hirning, MasterControl's product manager and pharmaceutical industry expert, is a pharmacologist with extensive IT experience in the pharmaceutical industry. He started his career as a research scientist at NPS Pharmaceuticals Inc. After seven years, he moved into an IT function, serving over a span of 12 years as IT Manager, IT Director, and Senior Director of Research IT. Since joining MasterControl in 2006, Hirning has specialized in product development for the pharmaceutical industry, with emphasis on regulatory and other requirements for clinical teams. He has a bachelor's degree in pharmacy from Idaho State University and a Ph.D. in pharmacology and toxicology from University of Arizona. He served as a post-doctoral fellow at the University of Chicago's Department of Pharmacology and Physiological Sciences. Hirning actively participates in industry events, such as seminars and workshops on computer system validation, lab informatics, and pharmaceutical development.

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