Tips for document management

It is critical that Life Sciences companies establish, document, and control their processes for authoring electronic documents, scanning paper documents, and handling each document type (e.g. CSR, Protocol, Summary, etc.) for each type of dossier (e.g. IND, NDA, BLA, PMA, eCTD, etc.).

Each type of document will present its own challenges to regulatory publishing. All documents to be authored for a dossier should be started with a template that includes agreed upon standards. Legacy documents should be scanned in, cleaned up, bookmarked and linked; headers and footers should be masked where appropriate. Standards and quality at the beginning of the document lifecycle lead to a more consistent and reliable dossier.

Here are some tips for managing your documents.

1. Establish the workflow of each stage of the document lifecycle

A few examples of workflow considerations are:

• Where will the documents be authored?
• When will the documents be imported into the repository?
• Which template should be used for which type of document?
• How will paper documents be scanned and cleaned?
• How will each stage of review take place?
• Who will perform the review? How will they be notified?
• How will corrections be handled?
• How will technology be utilised to control review processes?
• How will documents be approved?
• Who will sign off on them? Electronic or paper signatures?
• How will the documents be locked once approved?
• How will the document be amended post signature?
• When will the PDF rendition of the document be created?
• Where will the document be placed in the dossier structure?
• How may levels will the document be bookmarked?
• When will the document hyperlinks be created? During authoring? Before or after the dossier is published?
• Once the dossier is completed, where will the submitted copy reside within the repository?
• How will amendments be organised and tracked?
• How will documents be reused in other dossiers for the same indication? For other indications? Other agencies?

2. Document the workflow of each stage of the document lifecycle

The design of the document lifecycle should be clearly defined and available. Authors, reviewers and publishers should be well trained, and know what do to at each stage of the document lifecycle. Communication procedures between the personnel responsible for different stages of the lifecycle should be documented and followed. There should be a documented procedure for escalating issues to assure prompt resolution.

3. Control the workflow at each stage of the document lifecycle

Controls should be in place to ensure proper templates are used, review and approval methods are followed, publishing standards are followed, and results are cataloged for easy retrieval. It is important that, when configuring a content management system for your organisation, you assign controlled templates to be used for specific document types. For example, clinical authors creating a new document should be given the option of using a protocol template, study report template or tabular listings template.

Agencies have very specific requirements for minimum font sizes for tables and figures in order to maintain legibility when printing or viewing electronically.

It is also important that documents maintain a consistent look and feel, including consistent margins and navigation aids, which will be critical during the publishing and compilation of submissions. Accountability for quality materials, and timely handoff of materials, should be established at each stage of the lifecycle. Delays early in a document’s lifecycle can drastically impact the final dossier deliverable.

4. Establish document types and attributes

The various types of documents ultimately used in a submission require that diverse fields of information be used to identify their content. Clinical documents are often associated to protocols, protocol number, study reports, study number, phases, routes of administration, and at times site number and patient number when dealing with patient information such as informed consents and case report forms. With this diverse need for information, comes the importance of document types and the attributes associated with those document types. Figure 2 shows some examples of document types and the attributes that would relate to each of those documents.

Managing versions and changes of paper and electronic documents can often become not only difficult and time consuming, but prone to human error. A content management system is the best way to manage the lifecycle and process of such documents.

Patricia Santos-Serrao joined QUMAS Inc. in early 2005 as a Senior Regulatory Affairs Consultant with a focus on Clinical and Regulatory Affairs processes. Patricia has been in the Life Sciences industry since 1994, starting her career at Schering-Plough in Kenilworth, NJ and later joining Boehringer Ingelheim Pharmaceutical in Ridgefield, CT, both in Regulatory Affairs. Having had experience with global submissions for over eight years, Patricia moved into the solutions provider sector joining CDC Solutions, which was later acquired by Liquent and CSC, as a Business Process Specialist and Regulatory Specialist. Patricia assisted various customers during her time at CDC Solutions, Liquent and CSC in compiling eCTDs, and other submission formats worldwide. With over 12 years of industry experience in Regulatory and Clinical, Patricia assists QUMAS customers with an insider’s perspective on the industries’ content and submission management needs.