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In most of the companies, the Human Resource Dept. used to have timesheets made in excel sheets to maintain employee in and out time records. Yes, I know it is a lot tedious; however,

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

that was the best available resource for any company at that time. Companies used to offer excel timesheet software’s with in-build features like:
• The month has a drop down me

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

u selection. The month can still be typed in if desired but must not include any abbreviations.
• The year can be typed in as any year desired
• The total hours for a give

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

day are been displayed in hours and minutes.
• Hours worked and leave hours have totals at the bottom of the column.
• The totals of the columns including the monthly hou

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

r total gets displayed in hours and fractions of hours due to limitations on how Excel adds time values.

However the pains of maintaining an excel timesheet was always there

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ith the people managing them and the hunt for options was always on. Then there was Outlook Timesheets. Here the features were one up from excel timesheet like:
• It had user int

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

rface
• Remote access feature using Outlook / Exchange messaging solution.
• Project Timesheet feature wherein the project database gets integrated and employees can mention

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

the project they are charging time has to be mentioned.
• Approval Routing with Automatic Notification was another good feature of outlook timesheet.
• Administrators can s

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

t rules in outlook and
• Outlook companies claimed to provide the highest level of security.

All started going well for managers, however with the fast moving technology

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

companies started demanding flexibility according to their work environment that was not available in outlook. This is when Online Employee Timesheet came in as the solution for the

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ndustry.

Timesheet software allowed users to enter and approve timesheet and expense reports online using only a web browser. It is a comprehensive web-hosted timesheet software

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

application that streamlines time and attendance, expenses, benefits, time off, and other HR related processes developed specifically keeping your company requirements in mind.
T

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

mesheet software helps in eliminating paper work and reduces the countless hours lost to tedious tasks like repetitive data entry, error correction, and waiting for approvals. Timeshe

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

t software provides numerous features such as instant overtime calculators, mass approvals, automatically applied company OT rules, even automatic email reminders. Managing timesheet

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

software and projects online increases efficiency and number of benefits compared to traditional desktop-based installed software. Employees can log in to their timesheet software fro

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

any computer requiring only an internet connection and browser. Timesheet Software is available at all times, from home or the office, or even your client’s office. There are no time

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

heet software downloads, nothing to install and you are always using the most up to date version. Additionally, your data is hosted at state-of-the-art Data Center, guaranteeing immun

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ity against prolonged power outages, flooding, fire and other natural disasters. Companies offer Online Timesheet solutions with added features like Project Timesheet, Excel based Onl

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

ne Timesheets and many more.

Cheers

P Paul

Resources:
Online Employee Timesheet

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

arget="_new" href="http://www.iemployee.com/mkt/project-timesheet.htm">Project Timesheet
Workforce Management Solution

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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