One of the biggest challenges (or business pain points) for pharmaceutical manufacturers (or life sciences companies) is the long cycles that are required for research and development (R&D) and product approval. This is particularly a challenge for manufacturers of generic drugs, for which cycle times can average 20 months or more (and the full time-to-market period upwards of 12 years).
Why are long cycles a problem?
Simply put, it comes down to the familiar equation that “time = money.” More time needed means more capital spent, and manufacturers watch their bottom lines slip farther and farther away. To begin to formulate a plan to address the issue of long cycle times, it’s important to understand the factors that contribute to this challenge.
Long R&D cycles happen for a number of reasons. One is that there has been increasing need to comply with regulations, including the Food and Drug Administration’s (FDA’s) Title 21 Code of Federal Regulations (CFR) Part 11, for pharmaceutical manufacturers that are employing methods for electronic record-keeping and electronic and digital signatures.
This increasing need often means that additional administrative time must be spent on ensuring that the technical and procedural protocols are set up correctly and doing what they are supposed to do.
Another reason for long cycle times has to do with the need to ensure that all stages of product development are adequately documented for audits. Whether a manufacturer is using paper or electronic methods of data storage, there must be a reliable, consistent, secure, and accessible method of storing all documents related to the research, development, manufacture, and release of all drugs.
Every change to a document must be retained, and the integrity of the versions kept intact. For manufacturers straddling the line between paper-based and electronic methods, all paper-based documents need to be transferred and saved in digital form, a process that can require considerable time for scanning or manually entering data.
What are the business risks involved in longer R&D cycles and product approval?
Fewer products can be developed or manufactured concurrently, which means fewer products get to market. And fewer products to market can mean a decrease in the company’s in-coming cash flow (i.e. decreased profits). Additional worry may come from the fact that with this increase in time-to-market, other competing manufacturers may develop a similar drug and release it sooner, thereby further diminishing profits due to lost market share and a shortened product life cycle. A delayed or lengthened cycle time can seriously affect the return on investment (ROI) for a given new drug or product.
What can help?
A software solution that implements automated controls that address compliance issues, including 21 CFR Part 11.
How does 21 CFR Part 11 relate to product R&D and approvals?
For all of the processes involved in getting a drug to market, strict policies must be established and followed by a company regarding the use of electronic records. Each step of product R&D and approval processes must be, according to the dictates of 21 CFRR Part 11, consistent, reliable, and repeatable—in other words, each version of every document must be archived and easily retrieved for the purposes of inspection or auditing.
But this thorough documentation means that the approval process can be streamlined with automated functionality, as the time needed to send documents to the approving individual(s) will be reduced (with a centralized system, all users may have access to documents, providing they are authorized to do so according to level-specific electronic signatures; also, the system can be configured to send automatic notifications). Consequently, document turnaround time can be reduced, while the authenticity, integrity, non-repudiation, and confidentiality of documents is assured.
Furthermore, for the purposes of an audit, the automated system can aid a company by streamlining document retrieval. With a system that helps you organize and maintain accurate records of all processes, time isn’t wasted on following a lengthy paper trail of documents to ensure that changes have been authorized and tracked, and that all paper versions are now available.
However, it is very important to realize that using a software application off the shelf to automate all processes involved in electronic signatures, document archiving and change management, and tracking and auditing, will not automatically render your company compliant with 21 CFR Part 11.
You must also ensure that you configure the system so it provides you with the validation you need to be compliant—you must establish rules and policies for the application that are consistently followed so you can be assured your processes for electronic signatures and data management are compliant. Both procedural and administrative controls must be in place to ensure process compliance.
Software applications that can help pharmaceutical manufacturers with the issues described above include
For insight on the software selection process, check out TEC’s ERP for process manufacturing evaluation center.
Are you in the pharmaceuticals or life sciences industry? Tell us about the solution you’re using to reduce cycle times and manage regulatory compliance.
I am looking for more information on using BPM in life science compliance>
Some of the competing products for Teamcenter for Medical Devices.
FYI and research…