| Jim Nichols at Liquent, Thomson Scientific looks at how investment in record management technology and skills outsourcing is the best way to register pharmaceutical products and ensure that they gain market penetration – two ways to make the regulatory professional’s life easier and ensure a better night’s sleep
Managing the product registration process on paper alone can present many problems for life sciences companies already weighed down by extensive paper-trails. Companies that persist in developing procedures around paper-based processes and submissions can suffer from duplication and have the headache of the storage and retrieval of multiple copies of the paper document to deal with. These factors can create a significant and unnecessary burden and regulatory risk. By the same token, too many organisations fail to consider the other factors that go into making product registration work – that is, people and systems. Paper-based or manual processes are poor foundations for a successful product registration; staff not trained on the latest published rules and regulations is another concern.
PAPER-ONLY COLLECTION
When paper-based processes are working well, the organisation feels secure in the knowledge that its submission is available and stored securely in a physical location. But even with the best run physical filing systems, inefficiencies are inherent. If many copies of the same document are needed by the regulatory authorities, care must be given to version control and access. These problems are exacerbated if the regulatory departments are spread over multiple sites, introducing unnecessary time lags in approvals as staff track down time-sensitive information. Paper-based processes and submissions generally take longer to be compiled and dispatched to the regulatory authorities.
There is also the issue of overheads created by hiring additional staff to meet submission targets. It is estimated that managing documents to be included in a submission can end up requiring as many as nine full-time employees for a period of nine months. And an organisation that does hire the extra resource to meet the demands of the submission process is prey to being overstaffed once a submission is complete. |
