What is XML Authoring?
Big pharma's doing it and soon regulators will require it worldwide. What is XML authoring and why should you implement it from the very beginning in your startup biotechnology company?
According to the June 2006 issue of BioProcess International, as much as 80% of the business information collected and maintained by most biotechnology companies exists in the form of unstructured (non-data) content. This content includes documents such as:
- standard operating procedures (SOPs)
- research reports
- clinical protocols
- license applications
- advertising copy
- sales aids
- presentation slides
- batch records
- training materials
- manufacturing diagrams
It's easy for a new company to start recording everything on paper and stay stuck in that system as the company grows. Initial reactions are that it's probably easier, cheaper and faster to record data, prepare sales aids and training materials etc. without a complicated software program. However, in the long run, companies stand to save time and money in becoming more efficient using a business software solution such as XML authoring.
Extensible markup language (XML) is a computer language used to prepare documents that contain structured information. The language identifies different structures and content in a document. Software based on XML is used to make changes (add markup) to documents and facilitates sharing of data. In the biotechnology industry, XML is useful for ensuring that upgrades to a document (i.e. SOPs) are made universally throughout the company. If an SOP is distributed only in paper form, and a change is made, there is no sure way to know that all the old versions are destroyed or prevent their accidental use. Electronic content, if stored on an unsecured network of file servers, is at risk of accidental (unapproved) changes. Both of these scenarios can lead to inadvertent use of an obsolete or incorrect document.
Business and data management tools such as XML software ensure that communication between departments is consistent with changes made throughout the company. Small companies often rely on word-of-mouth systems of communication and fail to build the structure and develop habits of formal communication that are essential in larger corporations with significant numbers of staff. However, verbal communication, as informal as it may seem for small companies, leaves the door open for mistakes, loss of data, improper record-keeping (which can complicate licensing and IP protection), and leaves companies vulnerable to future disorganization and the huge task of implementing a more efficient system down the road.
XML authoring is accepted, even recommended, by regulators and used to reduce effort and improve the quality of content, through the use of a tailored online authoring environment. Use of XML software can eliminate mistakes and efficiently replicate revisions throughout the entire life-cycle of a product from start to finish. For example, if a critical product property is changed, XML authoring can ensure the change is reflected in the laboratory procedure (SOP), license application, product labels, technical data sheets etc., and prevent the use of an obsolete protocol for manufacture, or outdated information on presentation slides. I would strongly encourage use of XML authoring in any small or midsize biotech startup that is serious about quality control and particularly for those seeking ISO certification.
Regulations
The US Food and Drug Association (FDA) Structured Product Labeling (SPL) initiative requires product labelling submission in XML format as of October 2005. In Europe, the European Medicines Evaluation Agency (EMEA) has created a Product Information Management (PIM) initiative that is not yet mandatory but is expected, along with the SLP, to become an industry standard in the near future.
The FDA, and probably other regulators, will soon require use of an electronic common technical document (eCTD), due to the results of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) in Osaka, November 2003. The FDA has provided online guidelines for the process of creating eCTD backbone files, the ICH and FDA specifications that must be met, and the process of having the eCTD tested for technical problems, and approved, by the FDA.
