Managing Linear & Non-Linear Content Development

Transcription

1 Managing Linear & Non-Linear Content Development i4i s A4L Enterprise product supports the business process of label content production in the pharmaceutical industry, and the output and management of both PIM content and SPL content. A4L Enterprise also supports lifecycle management for both linear and non-linear changes to label content. This document provides a high-level overview of how the A4L Enterprise product manages both linear and non-linear processes 1 for changes to label content 2. Lifecycle Management During Document Exchange The PIM and SPL XML standards are essential for electronic label submission and, in the case of PIM and, soon, of SPL XML, for exchange with regulatory authorities. These standards are not, however, sufficient to satisfy business process requirements throughout the document lifecycle. The A4L system assigns unique identifiers to every important XML content object, and uses these identifiers to track both document and content components at all stages of the document lifecycle. Business process requirements are satisfied through configurable software modules that lever the tracking information. Managing Linear & Non-Linear Changes A4L is designed to ensure that change tracking is an integral part of the document development process, even if the process is non-linear. 1 By non-linear process we mean any process that implies simultaneous, non-sequential steps. For example, the creation of multiple, simultaneous translations, some of which may include revisions affecting the base document, requires non-linear processes. 2 It is expected that readers are familiar with, at a minimum: Exchange of Product Information Specifications V2.3, October 2006; and the SPL Implementation Guide for FDA Content of Labeling Submissions, Version 2a March, It is recommended that readers familiarize themselves with the i4i whitepaper The i4i Global Labeling Strategy, and with the available A4L product literature a i4i 1/7

2 These tracking capabilities do not rely on user decisions to track changes or to initiate comparisons, a model that is notoriously prone to oversight and error. Rather, A4L employs sophisticated comparison algorithms to check the content of every significant XML element in a document against previous versions to identify change automatically and in real time. Before describing A4L s unique management of non-linear processes, it is useful to how it manages linear processes, that is, standard versioning and lifecycle management. Appro Linear Change: Versioning and Lifecycle Management Each time a document, such as a pharmaceutical label, is updated the A4L system creates a new, unique version of the document, which it includes in its catalog of managed documents. A4L monitors and manages this document through all stages of its development. New: an author creates a new document and content for that document. When the author has completed work, A4L automatically routes the document to a specialist and changes its status to draft. Jacqueline worked on the ANTIBIOTiCX document in Draft form, checking it in to A4L as approved version 2.0 on She continued to work on it until users olawson and Ruth ed the document in parallel. Jacqueline merged their revisions into version 2.1 of the document, then set its status to Review. Draft: the specialist s and revises the existing content, and adds new content as required. When the specialist or another authorized user considers the document to be ready, he or she sets its status to. Review: with its status set to the document is routed to ers who have the authority to approve it. When the ers have signed off on their approval of the document, its status is set to approved. Revie Revie Revie Managing Linear & Non-Linear Content Development i4i /7

3 Approved: the approved document maintains this status until it is released to the competent authorities in the target jurisdiction. At this point, the status of the document is promoted to agency submission. An approved document can also be routed to translation for submission in different jurisdictions. Documents in translation have a cycle similar to that of a source document. In-use: Once it has been approved by all competent authorities and agencies the document is in use until further changes are required. Throughout a document s lifecycle the A4L system manages its progress from one status to the next, tracking all activities along with the identity of the persons who have made changes and ensuring that only authorized users can effect the changes that move a document through its lifecycle. In addition, A4L stores all previous versions of the document to maintain an auditable historical record accessible to authorized users. Antibiotcx (killall) Capsules The document ANTIBIOTICX (cephakillitall) was copied from the document Antibioticx (killall) Capsules. Non-Linear Change: Managing Relationships Between Documents In addition to the relatively straightforward management of linear document lifecycles, A4L manages non-linear relationships between documents and non-linear change. These capabilities can be illustrated by returning to the ANTIBIOTICX example above and considering what must happen when the document is routed into translation. When a user sends the ANTIBIOTCX document for translation, the original approved documents is used as a base for the translation. A4L retains the document s historic Managing Linear & Non-Linear Content Development i4i /7

4 information so that at any time users will know exactly what document was used as the base for the translations and, after translations have been made, precisely what translations were made from this base document. Managing Non-Linear Relationships Against MLDs, s & PIMs Most importantly for the pharmaceutical industry, A4L tracks and manages much more than the non-linear relationships required for translations. It tracks and manages the non-linear relationships necessitated by amendments, replacements and derivations, all relationships that are rendered complex by the need to support multiple parallel translation and submission activities simultaneously and in real-time. In the context of i4i s global labeling solution for the pharmaceutical industry, this capability means that the A4L system tracks significant XML elements, such as for instance, the overdose_s element that is used in the and, of course, in the PIM. Again, a simple example will help illustrate how the A4L system manages the nonlinear relationships in an XML labeling environment. A pharmaceutics manufacturer is required to provide s to four markets: English (U.K.), German, Italian and Spanish (Spain). The company s production process for s works as follows: 1. The base document is created and approved in English. 2. The approved base document is translated into other, target languages. 3. The translations are delivered to the local markets, where the are ed, updated as appropriate to meet local regulatory requirements and, finally, approved. 4. The final approved versions are then translated back into English. 5. These translations into English are combined with the approved English version to form the basis of the next version of the. With this process the company needs to know when changes are made to any of the multiple s, and it must know when these changes are significant so that it can act on them. Managing Linear & Non-Linear Content Development i4i /7

5 For instance, changes to the element manufacturer may not be considered significant at a given time because at that time the entire manufacturing section of the document is under revision. However, changes to the element overdose_s are always considered significant, and any change to this element in any requires immediate follow up. The wording in overdose is centrally determined. If it is changed to meet a local requirement the company needs to notified immediately so that it can determine how to deal with the introduced variant. If the change is innocuous the company may only need to notify all other local representations to check their wording and report back to headquarters. If the change is a correction of a serious error in the original English document the company needs to act immediately to manage consequences of the error. In order to act effectively it must know the scope and extent of the problem. Knowing exactly which documents in what stage of their lifecycle are possibly affected is critical piece of knowledge. To meet these sort of time sensitive, critical tracking and management requirements, A4L can generate reports on the use and evolution of the overdose_s element, or of any other element determined by the user. The diagram shows that overdose_s section taken from the approved English is translated into three languages; German, Italian and, Spanish. As expected, English approved the overdose_s element changes. These changes are noted by A4L, which continues to track the overdose_s element in all translations, identifying changes to the element new new new Conceptual model of A4L non-lineal tracking approved German Italian Spanish Managing Linear & Non-Linear Content Development i4i /7

6 accordingly. There are no changes from the translation in the first stages. In fact the Spanish successfully moves to the approved state meaning that it is ready for agency submission. However, a change appears in the second of the Italian version. This needs to be acted on immediately. Is the change due to local requirement that has no impact on the English and Spanish versions that are ready for agency submission? or is the change a correction of a critical error in the wording of the overdose_s section and, if so, who needs to be notified immediately? A4L cannot answer the first question, that requires user intervention and interpretation but A4L can answer the second question. Most importantly A4L provides the infrastructure that even permits these questions to be asked immediately on their becoming relevant. Conclusion A4L tracks and manages the complete document lifecycle, from document creation through to approval and publication. It records and maintains for future reference the date and time of all actions, and the identity of the user who performed the action. A4L s capabilities extend far beyond the standard management of linear processes, however. A4L tracks and manages the non-linear document relationships inherent to translated documents and, as part of a complete framework for the development and management of label documents, it automatically tracks all changes to significant XML elements as required by the user and in so doing allows mission critical business processes to be initiated and managed without the inherent delays and unreliability of traditional systems. About i4i Infrastructures for Information Inc. (i4i) is an independent software manufacturer specialized in the production of XML software to support content development and management processes. While its platform technologies: x4o a full function XML editor inside of MS-Word, and Alice, a suite of XML and document management Web services are used in many industries, i4i s vertical market focus is Life Sciences, specifically Labelling. i4i provides specific products developed for the life sciences: A4L Professional for the XML authoring of PIM, QRD and SPL documents, and other label related documents; Managing Linear & Non-Linear Content Development i4i /7

7 and A4L Enterprise, Web services to support the content development and management processes. i4i is a key member of the SPL working group. i4i s representative to the group is the lead for the technical team, and is an active participant in the development of the implementation and process guides. i4i clients outside the life sciences vertical include the Smithsonian Institution, the Canadian Department of National Defence and Bell South Corp., the US telecom giant. i4i 116 Spadina Avenue, 5th Floor Toronto, Ontario Canada M5V 2K6 Tel: Fax: sales@i4i.com. Managing Linear & Non-Linear Content Development i4i /7