Ramco returned its request for information (RFI) for HCM, and as analysts, we compared it against the combined responses of other vendors within the HR space. Ramco responded to the RFI with almost total support against all criteria. There were several flags against various supported entries. (Flags are more often signs of superior functionality.)

TEC’s way of certifying any vendor—including Ramco—is fair and impartial. Over the years, TEC has created an RFI form tailored to HCM, which has been completed by many vendors of HCM products. TEC has a database of the responses that correspond to the RFI. Through the gathering of such data, we know statistically when an RFI criterion is industry “supported,” whether it is a “customization,” or if it holds some other status. In cases where the general industry response is different from the respondents, the software “flagged” that response.

The next step in the certification process is to verify the RFI by constructing a validation suite of criteria that the vendor must demonstrate. The “supported flag entries” mentioned above are also included. TEC sends this validation list (or demo script) to the vendor two weeks prior to the certification meeting. This validation list is required in order for the vendor to demonstrate that the level of support for a particular functionality is as it has claimed. We also include other items that are essential to HCM functionality. As analysts, we play the role of examiner, with a “show me the functionality; I want to validate your responses” approach.

Overall, the Ramco certification went very well. Ramco’s analysts demo’ed the product. There was not one aspect of HCM that they did not know or demo. Not once was there the response of “I’ll get back to you.” Every “flagged” item that we noted as supported passed the test.

In validating over 200 entries, we noted the following:

* The entire user interface is browser-based and very easy to use.
* The HCM product is very rich in functionality.
* The menus are well organized, with common functionalities grouped together.
* The detail screens were not cluttered, making them easy to read.
* Horizontal scrolling was used when an entry required more data than what a line could contain.
* Data screens were user-friendly and easily searchable.
* The general layout and functionality was impeccable.

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.

When migrating between systems, it is crucial to define the scope of implementation, as well as to outline each stage of the project and the resources that will be needed. A failed implementation will paralyze the operational capabilities of an organization, but the right methodology will help ensure a successful implementation.

In the issues related to the areas of ERP and PLM integration, we’ll highlight relevant areas of consideration. Furthermore, you’ll learn what steps can be taken to safeguard purging and data retention. This is a legal and mandatory business consideration.

We’ll assume for the purposes of this blog post that a new system exists, and that we are migrating data from an existing legacy system to a new ERP/PLM system. This can be viewed as an in-house system upgrade, or as migration of data from a purchased company.

Purging and Data Retention

When production databases become too large, they impact productivity by slowing access to information, and by extending the time required for system backups or for system restores.

Depending upon the industry (for example, medical, government, etc.), the need for data retention varies based on regulatory compliance. Some industries have long duration product guarantees, which results in the necessity to retain data.

Archiving has evolved into a discipline known as information lifecycle management (ILM). ILM helps organizations maximize the business management of storage from creation to disposal. Management is understandably reluctant to perform data purges due to the unknown operational risks, and it is therefore often done in stages.

Unstructured data populates file servers and typically includes e-mails, drawings, and user- and application-generated files in hundreds of unique formats. Purging can be by date, by type (internal or external), and by inbound or outbound status. Nevertheless, while many IT shops are only archiving e-mail to a less expensive tier of storage, they are still unwilling to permanently purge e-mail for legal or operational reasons.

The usual approach consists of transfer of data from active tables to online historical backups on a monthly basis. Since historical data is essentially invariant for long periods, it does not require being re-backed up if it had no changes. The backup facility may also make a second copy to non-rewritable storage. In the process of creating archives, an accompanying step is often taken to create summary data into a data-warehousing product for business intelligence studies. Summary data allows a look at a product’s sales figures for a given time period, by examining a single entry in a table rather then summing up individual sales order lines.

Newer Posts Older Posts Home