Pharmaceuticals
The heavily regulated pharmaceutical industry also has stringent Information Technology requirements. Audit trails must be complete and vital business documents can be accessed only by authorized personnel.
"Compliance" and "validation" are two key words in biotech and pharmaceutical companies. The process of introducing a new drug or a new biotechnological process to market is spread out over years and spans multiple departments within a company. The task of keeping track of progress on individual projects is very complicated.
Biotech and pharmaceutical companies need to have detailed audit trails on the creation and modification of various documents during the development of a drug or a process. This is essential if drug dossiers are to be submitted to the FDA for approval. Any documents submitted to the FDA for validation, under 21CFR Part 11, are recommended to be easily searchable and available in a human readable form. The audit trails in particular must be time-stamped to ensure their trustworthiness and reliability. This means that document management must be enterprise-wide, so that deliverables from all the users can be easily accessed and collated by the project managers, cutting down on the time needed for a company to prepare for validation.
Biotech and pharmaceutical companies are faced with the following challenges while managing the critical documents:
- High Costs:
- Biotech and pharmaceutical companies have their facilities and employees scattered in different locations. It might be cheaper to maintain separate records management systems for different locations, but the inefficiency of paper-based or stand alone systems becomes counterproductive and costs a lot of money in terms of man hours.
- Due to lack of collaboration and centralized knowledge repository,
same documents have to be recreated over and over again costing a lot
of money.
- Storage and Search Issues:
- It is extremely difficult to search for paper documents and costs a lot in terms of time and man hours. According to 21CFR Part 11 for FDA validation, it is recommended that documents should be easily searchable and available in a human readable form.
- Paper documents require a lot of expensive storage space.
- Communication Issues:
- In a paper-based systems, the document review process can be long and
cumbersome. It requires a lot of meetings to discuss changes and obtain
approval and signatures. When a change is rejected, more meetings are
called for resulting in loss of time and man hours.
- Tracing Audit Trail
- Biotech and pharmaceutical companies need to have detailed audit trails on the creation and modification of various documents during the development of a drug or a process. This is essential if drug dossiers are to be submitted to the FDA for approval. If a detailed audit trail is not available, it becomes very difficult for an organization to prepare for validation on time.