The corporate workplace is not for the faint of heart. Any time you get a group of people together with different backgrounds and interests and isolate them into large fabric-covered boxes, chances are that you’ll find some personality clashes.
While not every office is subject to anecdotes about Dwight Schrute’s life on the beet farm or the ineptitude of Dilbert’s pointy-haired boss, there are probably some workplace idiosyncrasies that—given the opportunity—you would just as soon avoid. You know what I’m talking about. Maybe you’re getting a little too much information about your coworkers on casual day. Or maybe—now that the obsessive conversation over the American Idol results has died down—there are awkward silences near the water cooler. It could just be that you’d like to steer clear of that coworker who is so fanatical about her hobby that she can’t talk about anything else. (Seriously. We’re all concerned about the honeybee decline, but there are other things to talk about.)
Enterprise content management (ECM) won’t decrease your incidence of email lottery notifications or male enhancement-related spam, but it can help you retain your sanity in the workplace. For those days when you just want to get your work done without interruption— whether it comes in the form of a debate about the discrepancies in the most recent Star Trek movie or a one-sided conversation about why your coworker’s cats are the best pets in the entire history of domesticated animals—consider these benefits:
1. Business process management (BPM) eliminates the need to drop the paperwork off at your annoying coworker’s desk.
With BPM, you can distribute, receive, and access work and online files digitally. This means that all of the information that you need to process your work is available immediately, accessible with the click of a mouse. In addition to enabling you to increase your productivity and improve services to customers and partners, this means that you can also avoid overhearing that phone conversation that is so important that your coworker feels the need to broadcast it on speakerphone.
BPM gives you secure, immediate access to your work documents from any web browser. So if you are the employee who is unfortunate enough to have a cubicle next to the woman who insists on coming to work when she’s sick, it might be nice to have the option of working remotely during cold and flu season. In these days of potential global pandemics, you can’t be too careful.
2. Electronic access ensures that your records are available whenever you need them. Even if your coworkers are alphabetically challenged.
Under a paper-based system, it’s not uncommon for records to be duplicated, misfiled, or even lost. Without question, this can be a major cause of annoyance. The news is worse if you look at the big picture: in a compliance environment that grows continually more rigid, mismanagement of your records can result in expensive penalties. An enterprise content management system lets you scan and store those paper records in an electronic repository along with your business forms, faxes, images, documents (paper and electronic), personnel files, etc. The information that you need to process your work efficiently is only a mouse click away.
If your annoying coworkers are misplacing files, there may also be a chance that they’re not paying attention to document lifecycles. Are you holding on to records beyond their mandated retention times? Are you (or your annoying coworkers) shredding documents prior to their mandated destruction times? Mismanagement of records has repercussions that go well beyond annoyance in the workplace. It can lead to fines and stiff penalties—especially if you are required to produce specific information in cases of e-discovery.
3. ECM means never having to say you’re sorry.
Got an annoying coworker who tries to throw you under the proverbial bus when the work doesn’t get done on time? ECM provides businesses with tracking tools that can prove, irrefutably, who is doing what. Tracking allows organizations to better manage their processing loads. On the personal level, your annoying coworker can no longer take credit for work that was done by someone else. More importantly, consider what it means from an enterprise standpoint: work can be distributed according to standards that you set ahead of time, using parameters such as round robin, first in, first out (FIFO), lightest workload, and other criteria.
Having work distributed electronically ensures that your annoying coworker—the one who is always complaining that “he’s bored”— constantly has work flowing into his inbox. Other workers whose positions might include repetitious, monotonous tasks can be transitioned to areas that allow them to use critical thinking. Processing efficiency is improved significantly, turnaround is improved, and your annoying coworker can move on to his next area of grievance.
4. Without ECM’s integration capabilities, you can’t get there from here.
Sometimes, even annoying coworkers have legitimate complaints. Take, for example, someone whose job it is to use information from a legacy system in order to process work. More often than not, data from legacy systems is—at best—difficult to retrieve. Software system incompatibility can make life difficult, and can result in the need to constantly re-key information. A system that doesn’t communicate well with other software can result in processing slowdowns and delays.
A high-performance ECM system has the capability to make information available quickly and easily throughout your entire enterprise. It should offer easy integration with your line of business applications, back-office system, website, portal, office environment, and the other systems that keep your business running smoothly. An ECM system that is underwritten in open standards will not limit you to proprietary software when choosing components to complement your technology infrastructure.
An ECM system is supposed to simplify your life. It shouldn’t require complicated programming if you want to call documents from within your storage repository. It should also integrate into your current line of business applications without the need for programming. Your annoying coworkers have enough to whine about. A system with robust integration may not alter their outlook on life, but it will make their lives easier.
5. An easy-to-use ECM system silences the chronic complainer.
You’ve heard the complaints. Her job is so hard. She has soooooooooo much work to do. How is she going to get everything done? She’s overworked, underappreciated, frazzled, and—as you might guess—feels the need to share the love. When the complaints dominate the workplace to the point where you just want to stick needles in your eyes, bang your head against the wall, and chew on tin foil, it’s definitely time to consider ECM. A system that is easy to use will bring order and efficiency to the workplace.
ECM will silence your coworkers’ complaints about not being able to find the right documents to process their work. Information will be available at the fingertips of authorized users—securely—from any web browser. There will no longer be any muttering about other staff hogging the files that your coworker needs in order to do her job. Files can be viewed simultaneously, from different locations. Complaints about rude customers become obsolete when you are able to provide immediate customer service.
Work is distributed to you and your coworkers at a manageable pace. You may not be able to have much of an impact on the social skills of people who tend to consistently see the glass as half-empty. But with ECM, you can eliminate the factors that contribute to complaints about work. You’re on your own when your coworkers start elaborating about their personal lives.
Source: - www.ecmconnection.com
Saturday, June 27, 2009
Saturday, June 20, 2009
How Effective Document Management Helps Pharmaceutical Companies Accelerate Time to Market
Introduction
Translating a scientific idea into a safe medicine that benefits millions of people is a long, difficult, and expensive process. It takes 10 to 15 years at a cost of $800 million to $1 billion to bring a new drug from a laboratory to a pharmacy shelf, according to the Pharmaceutical Research and Manufacturers of America (PhRMA).
Let’s take the hypothetical example of a young pharmaceutical company with one product so far. The company obtained a 20-year patent for its new drug at the start of the discovery process. Let’s say it took 11 years for the company to develop the drug and get it approved by the FDA. Taking out 11 years of development time from the 20-year period of exclusivity under the patent would leave the company only nine years to capture the full value of its product before generic competitors enter the market. A company loses 75 percent of its pre-generic sales in the first year that competition enters the market, according to Josef Bossart, founder and principal of Bossart4 Bioconsult, in an article in the July-August 2006 issue of Specialty Pharma. The loss is estimated to increase to 85 percent in the second year, and 90 percent beyond that.
Needless to say, the period of exclusivity for a new drug is critical. Any delay that cuts this period could cost the company a lot. In the drug development process, time is indeed money. So it only makes sense to try to reduce delays in every phase of the process. But how and where do you begin to save time?
The fact is, drug development requires document-intensive work. It behooves a pharmaceutical or biotechnology company or a contract research organization (CRO) to start with a basic activity that must be performed throughout the drug development cycle: document management. From the scientists leading the drug discovery process to the marketing specialists writing a new drug’s labeling — they all need to document their activities for a variety of reasons. More importantly, they need to control or manage their documents. So any delay caused by poor document management could affect overall time to market.
This white paper will discuss common challenges pertaining to document control encountered by most drug companies from the preclinical stage through the post-market phase, and how the MasterControl™ GxP process and document management software solution addresses such challenges.
Preclinical Phase
One could say that the years spent by chemists, biologists, pharmacologists, toxicologists, and other scientists “discovering” the right combination of chemical and biological substances that could be used for a drug are geared toward the submission an investigational new drug (IND) application. FDA approval of the IND is necessary to conduct clinical trials and to proceed with product development.
Discovery research scientists typically start with thousands of possible compounds. Through continuous testing, screening, and refining that could take several years, they would whittle down the thousands of compounds to hundreds, and then dozens, and then three to five drug “candidates.” This rigorous phase includes laboratory and animal studies that cover chemistry tests, biological tests, manufacturing tests, and pharmaceutical development studies. The overarching goal during this phase is to determine the safety of the candidates before they are tested in people.
The preclinical phase could easily generate thousands of documents. The IND submission alone requires the compilation of everything known about the new drug being developed: its chemical structure; how it might work in the human body; how it works in animals; any side effects in animals; and how the compound is manufactured. The IND also must include detailed information on how the company plans to test the drug on humans during clinical trials.
Pharmaceutical and biotech companies and the CROs that serve them need effective document control during this phase for two major reasons that directly affect time to market:
* Efficiency: Thousands of documents generated over a period of one to three or more years necessitate a formal document control process to ensure that documents are not lost, and that they can be tracked, retrieved, revised, and approved easily. Without an efficient system for managing documents, thousands of man-hours will be spent in even the simplest tasks.
* Compliance: FDA regulations such as 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies) and 21 CFR Part 312 (Investigational New Drug Application) require effective documentation. 21 CFR 58 has specific document control requirements pertaining to SOPs for animal care, lab tests, data handling, and equipment maintenance and calibration; protocols; and handling of records, reports, and raw data documentation. 21 CFR 312 has its own set of requirements pertaining to recordkeeping, record retention, and investigator reports. Management of IND documentation is particularly crucial because it serves as the basis for other information that will be submitted to the FDA later.
Clinical Phase
While preclinical work is directed toward the IND submission, the clinical phase is geared toward the submission of an equally important regulatory filing: the new drug application (NDA).
During this stage, doctors (called clinical investigators) carry out studies to find out if the drug is safe in people and whether it is effective in treating the targeted disease. There are three phases in every clinical trial: Phase I (the drug is tested in 20 to 100 healthy volunteers), Phase II (involving 100 to 500 volunteers who have the disease that the new drug is meant to treat), and Phase III (involving 1,000 to 5,000 volunteer patients).
Clinical trials could take up to 10 years, during which the sponsor will conduct parallel research on toxicity, dosage forms, and methods for full-scale manufacturing and packaging of the drug. Everything about the clinical phase is geared toward the NDA submission, which essentially summarizes 10 or more years of development work. The NDA dossier is complex and voluminous — anywhere from 100,000 to 600,000 pages of text that are meant to persuade the FDA to approve the new drug.
As in the preclinical phase, if not more so, the clinical stage requires effective document control to help achieve:
* Efficiency: Managing hundreds of thousands of documents generated by cross-functional teams during a period of 10 years or more is a daunting challenge. Bottlenecks abound during this phase because there are more people involved in the process and the data from clinical investigators grow exponentially from Phase I through Phase III.
* Compliance: In addition to GLP and GCP requirements that various teams must comply with, the sponsor also must manufacture the investigational new drug used for clinical trials in accordance with Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Parts 210-211. GCP also includes guidances that call for effective documentation. Moreover, the sponsor must comply with 21 CFR Part 314 (Applications for FDA Approval to Market a New Drug) for its NDA submission.
Commercialization, Product Launch, and Post-Market Phase
While a sponsor is waiting for FDA approval, it is likely to be gearing up for mass production, or perhaps it is already manufacturing the drug. FDA approval takes 18 months on the average, according to PhRMA. As soon as the FDA approves the NDA, the company will be able to start selling the new drug. But even after the product is brought to the market, the company will continue to submit reports to the FDA, such as adverse reaction reports and quality-control records. In some cases, the FDA may require a sponsor to conduct Phase IV clinical trials to evaluate the drug’s long-term effects.
With the clock ticking in terms of market exclusivity, the company that has just launched a new drug needs effective document management to help achieve:
* Efficiency: Document control needs after FDA approval are especially great in the areas of quality control, manufacturing, marketing, and sales. Voluminous documents will be generated by quality-related processes that will handle corrective and preventive action (CAPA), electronic batch records (EBR), consumer complaints and adverse event reports, quality audit, deviations, and nonconformances, among others.
* Compliance: Document control is a CGMP requirement. In addition, the pharmaceutical or biotech company with a newly approved NDA must address post-market requirements found in 21 CFR Part 314, including the reporting of adverse drug experiences and the submission of NDA field alert report, annual report, distribution data, labeling, report on CMC changes, etc.
The MasterControl Solution
The MasterControl™ GxP process and document management software provides a solid foundation for effective document control that will help accelerate overall time to market by simplifying workflows, promoting efficiency, and making compliance easier. Below are some of the benefits of using MasterControl throughout the drug development process.
Increased Efficiency Through Automation. MasterControl reduces document cycle time and simplifies document management by automating routing, notification and follow-up, escalation, and approval. Its robust tracking feature identifies bottlenecks by showing when a document was sent and to whom. It shows the document’s history, including who has approved it and when. A document that has been rejected will automatically go back to the sender, so tasks don’t languish. MasterControl can handle all types of documents, regardless of the software used to create them.
Centralized Repository Makes Search and Retrieval Easier. You can store all records and documents from the discovery stage through the post-market phase in a centralized electronic repository, making it easier to update, and to search and retrieve them. Documents reside in secure virtual vaults that can be accessed only by authorized users. Access is limited by the extent of a user’s system rights. Although the system is centralized, every department can compile documents separately using the Organizer, a MasterControl tool similar to Windows Explorer, which helps users find documents quickly.
Web-Based Platform Provides Easy Access. A Web-based system will give employees in different locations and time zones easy access. Even CROs, suppliers, consultants, and other authorized users outside of the company can have system access based on the extent of their roles in any document-based process.
Automatic Revision Control Reduces User Mistakes. With a paper-based document control process, there is no mechanism that would stop a user from inadvertently using obsolete or unapproved documents. With MasterControl, revision control is automatic, so only approved documents are released. Any outdated documents are automatically archived, and documents in the process of revision are locked. The system provides a time-stamped audit trail of all changes made to a document.
Virtual Workspace Makes Collaboration Easier. Collaboration is possible regardless of location through a virtual workspace for cross-functional review and approval of documents. The system automates tasks pertaining to collaborative projects, including routing, follow-up, escalation, and approval.
Best Practices Help Streamline Workflows. To increase efficiency, MasterControl incorporates best practices in critical processes such as CAPA, nonconformance disposition, deviation handling, EBR management, quality audit, change control, or any document-based or forms-based process. Best-practice workflows can be used as is or customized.
Electronic Approval Fosters Efficiency. The capability to review and approve documents electronically speeds up the approval process significantly. Signature manifestation can be appended automatically to each document as required by 21 CFR Part 11. In addition to e-signature, the system provides a time-stamped audit trail that can be linked to the approval process.
Integrated Approach Connects Document Control with Other Processes. MasterControl connects the document control process with other processes, and it synchronizes changes in documents and documented processes. For example, document control can be integrated with customer complaints, CAPA, and training control processes. So a customer complaint serious enough to require a CAPA will be automatically escalated to the CAPA process. Any document change resulting from an approved CAPA will automatically trigger training on the revised document for all affected employees.
Integration Helps Optimize E-Submission Process. MasterControl can be integrated with leading e-submission tools to optimize and accelerate the electronic submission process. MasterControl provides a single repository for all regulatory submissions, as well as a virtual workspace where different teams can easily and quickly revise the dossier.
Integration Helps Leverage Existing Systems. You can leverage your existing systems, such as ERP, PDM, and PLM, by integrating them with robust MasterControl applications without expensive custom coding.
Risk-Based Software Validation Offerings Help Reduce Compliance Burden. MasterControl offers a line of products and services designed to dramatically reduce the time, pain, and cost involved in software validation. Companies may choose the appropriate products and services based on their own risk assessment.
Flexible Approach Makes System Ownership More Cost-Effective. While mature companies typically prefer to purchase a full MasterControl suite outright, many smaller companies choose the application server provider (ASP) service for a minimal upfront cost. This approach allows fast deployment, offers software validation services, and requires no technical maintenance or special equipment. Companies may select an ASP system that is purely document management and 100 percent preconfigured. Or, as their needs grow, they may want more customization and additional applications (CAPA, change control, training control, etc.) to fit their requirements.
Conclusion
Time is a precious commodity for everyone, but especially for people involved in drug development. You can maximize development time starting with the way you control document-based processes. As this white paper has shown you, a delay in time to market due to poor document management is largely preventable with the help of the right solution
Article Source http://www.ngpharma.com/article/Issue-10/Manufacturing/How-Effective-Document-Management-Helps-Pharmaceutical-Companies-Accelerate-Time-to-Market/
Translating a scientific idea into a safe medicine that benefits millions of people is a long, difficult, and expensive process. It takes 10 to 15 years at a cost of $800 million to $1 billion to bring a new drug from a laboratory to a pharmacy shelf, according to the Pharmaceutical Research and Manufacturers of America (PhRMA).
Let’s take the hypothetical example of a young pharmaceutical company with one product so far. The company obtained a 20-year patent for its new drug at the start of the discovery process. Let’s say it took 11 years for the company to develop the drug and get it approved by the FDA. Taking out 11 years of development time from the 20-year period of exclusivity under the patent would leave the company only nine years to capture the full value of its product before generic competitors enter the market. A company loses 75 percent of its pre-generic sales in the first year that competition enters the market, according to Josef Bossart, founder and principal of Bossart4 Bioconsult, in an article in the July-August 2006 issue of Specialty Pharma. The loss is estimated to increase to 85 percent in the second year, and 90 percent beyond that.
Needless to say, the period of exclusivity for a new drug is critical. Any delay that cuts this period could cost the company a lot. In the drug development process, time is indeed money. So it only makes sense to try to reduce delays in every phase of the process. But how and where do you begin to save time?
The fact is, drug development requires document-intensive work. It behooves a pharmaceutical or biotechnology company or a contract research organization (CRO) to start with a basic activity that must be performed throughout the drug development cycle: document management. From the scientists leading the drug discovery process to the marketing specialists writing a new drug’s labeling — they all need to document their activities for a variety of reasons. More importantly, they need to control or manage their documents. So any delay caused by poor document management could affect overall time to market.
This white paper will discuss common challenges pertaining to document control encountered by most drug companies from the preclinical stage through the post-market phase, and how the MasterControl™ GxP process and document management software solution addresses such challenges.
Preclinical Phase
One could say that the years spent by chemists, biologists, pharmacologists, toxicologists, and other scientists “discovering” the right combination of chemical and biological substances that could be used for a drug are geared toward the submission an investigational new drug (IND) application. FDA approval of the IND is necessary to conduct clinical trials and to proceed with product development.
Discovery research scientists typically start with thousands of possible compounds. Through continuous testing, screening, and refining that could take several years, they would whittle down the thousands of compounds to hundreds, and then dozens, and then three to five drug “candidates.” This rigorous phase includes laboratory and animal studies that cover chemistry tests, biological tests, manufacturing tests, and pharmaceutical development studies. The overarching goal during this phase is to determine the safety of the candidates before they are tested in people.
The preclinical phase could easily generate thousands of documents. The IND submission alone requires the compilation of everything known about the new drug being developed: its chemical structure; how it might work in the human body; how it works in animals; any side effects in animals; and how the compound is manufactured. The IND also must include detailed information on how the company plans to test the drug on humans during clinical trials.
Pharmaceutical and biotech companies and the CROs that serve them need effective document control during this phase for two major reasons that directly affect time to market:
* Efficiency: Thousands of documents generated over a period of one to three or more years necessitate a formal document control process to ensure that documents are not lost, and that they can be tracked, retrieved, revised, and approved easily. Without an efficient system for managing documents, thousands of man-hours will be spent in even the simplest tasks.
* Compliance: FDA regulations such as 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies) and 21 CFR Part 312 (Investigational New Drug Application) require effective documentation. 21 CFR 58 has specific document control requirements pertaining to SOPs for animal care, lab tests, data handling, and equipment maintenance and calibration; protocols; and handling of records, reports, and raw data documentation. 21 CFR 312 has its own set of requirements pertaining to recordkeeping, record retention, and investigator reports. Management of IND documentation is particularly crucial because it serves as the basis for other information that will be submitted to the FDA later.
Clinical Phase
While preclinical work is directed toward the IND submission, the clinical phase is geared toward the submission of an equally important regulatory filing: the new drug application (NDA).
During this stage, doctors (called clinical investigators) carry out studies to find out if the drug is safe in people and whether it is effective in treating the targeted disease. There are three phases in every clinical trial: Phase I (the drug is tested in 20 to 100 healthy volunteers), Phase II (involving 100 to 500 volunteers who have the disease that the new drug is meant to treat), and Phase III (involving 1,000 to 5,000 volunteer patients).
Clinical trials could take up to 10 years, during which the sponsor will conduct parallel research on toxicity, dosage forms, and methods for full-scale manufacturing and packaging of the drug. Everything about the clinical phase is geared toward the NDA submission, which essentially summarizes 10 or more years of development work. The NDA dossier is complex and voluminous — anywhere from 100,000 to 600,000 pages of text that are meant to persuade the FDA to approve the new drug.
As in the preclinical phase, if not more so, the clinical stage requires effective document control to help achieve:
* Efficiency: Managing hundreds of thousands of documents generated by cross-functional teams during a period of 10 years or more is a daunting challenge. Bottlenecks abound during this phase because there are more people involved in the process and the data from clinical investigators grow exponentially from Phase I through Phase III.
* Compliance: In addition to GLP and GCP requirements that various teams must comply with, the sponsor also must manufacture the investigational new drug used for clinical trials in accordance with Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Parts 210-211. GCP also includes guidances that call for effective documentation. Moreover, the sponsor must comply with 21 CFR Part 314 (Applications for FDA Approval to Market a New Drug) for its NDA submission.
Commercialization, Product Launch, and Post-Market Phase
While a sponsor is waiting for FDA approval, it is likely to be gearing up for mass production, or perhaps it is already manufacturing the drug. FDA approval takes 18 months on the average, according to PhRMA. As soon as the FDA approves the NDA, the company will be able to start selling the new drug. But even after the product is brought to the market, the company will continue to submit reports to the FDA, such as adverse reaction reports and quality-control records. In some cases, the FDA may require a sponsor to conduct Phase IV clinical trials to evaluate the drug’s long-term effects.
With the clock ticking in terms of market exclusivity, the company that has just launched a new drug needs effective document management to help achieve:
* Efficiency: Document control needs after FDA approval are especially great in the areas of quality control, manufacturing, marketing, and sales. Voluminous documents will be generated by quality-related processes that will handle corrective and preventive action (CAPA), electronic batch records (EBR), consumer complaints and adverse event reports, quality audit, deviations, and nonconformances, among others.
* Compliance: Document control is a CGMP requirement. In addition, the pharmaceutical or biotech company with a newly approved NDA must address post-market requirements found in 21 CFR Part 314, including the reporting of adverse drug experiences and the submission of NDA field alert report, annual report, distribution data, labeling, report on CMC changes, etc.
The MasterControl Solution
The MasterControl™ GxP process and document management software provides a solid foundation for effective document control that will help accelerate overall time to market by simplifying workflows, promoting efficiency, and making compliance easier. Below are some of the benefits of using MasterControl throughout the drug development process.
Increased Efficiency Through Automation. MasterControl reduces document cycle time and simplifies document management by automating routing, notification and follow-up, escalation, and approval. Its robust tracking feature identifies bottlenecks by showing when a document was sent and to whom. It shows the document’s history, including who has approved it and when. A document that has been rejected will automatically go back to the sender, so tasks don’t languish. MasterControl can handle all types of documents, regardless of the software used to create them.
Centralized Repository Makes Search and Retrieval Easier. You can store all records and documents from the discovery stage through the post-market phase in a centralized electronic repository, making it easier to update, and to search and retrieve them. Documents reside in secure virtual vaults that can be accessed only by authorized users. Access is limited by the extent of a user’s system rights. Although the system is centralized, every department can compile documents separately using the Organizer, a MasterControl tool similar to Windows Explorer, which helps users find documents quickly.
Web-Based Platform Provides Easy Access. A Web-based system will give employees in different locations and time zones easy access. Even CROs, suppliers, consultants, and other authorized users outside of the company can have system access based on the extent of their roles in any document-based process.
Automatic Revision Control Reduces User Mistakes. With a paper-based document control process, there is no mechanism that would stop a user from inadvertently using obsolete or unapproved documents. With MasterControl, revision control is automatic, so only approved documents are released. Any outdated documents are automatically archived, and documents in the process of revision are locked. The system provides a time-stamped audit trail of all changes made to a document.
Virtual Workspace Makes Collaboration Easier. Collaboration is possible regardless of location through a virtual workspace for cross-functional review and approval of documents. The system automates tasks pertaining to collaborative projects, including routing, follow-up, escalation, and approval.
Best Practices Help Streamline Workflows. To increase efficiency, MasterControl incorporates best practices in critical processes such as CAPA, nonconformance disposition, deviation handling, EBR management, quality audit, change control, or any document-based or forms-based process. Best-practice workflows can be used as is or customized.
Electronic Approval Fosters Efficiency. The capability to review and approve documents electronically speeds up the approval process significantly. Signature manifestation can be appended automatically to each document as required by 21 CFR Part 11. In addition to e-signature, the system provides a time-stamped audit trail that can be linked to the approval process.
Integrated Approach Connects Document Control with Other Processes. MasterControl connects the document control process with other processes, and it synchronizes changes in documents and documented processes. For example, document control can be integrated with customer complaints, CAPA, and training control processes. So a customer complaint serious enough to require a CAPA will be automatically escalated to the CAPA process. Any document change resulting from an approved CAPA will automatically trigger training on the revised document for all affected employees.
Integration Helps Optimize E-Submission Process. MasterControl can be integrated with leading e-submission tools to optimize and accelerate the electronic submission process. MasterControl provides a single repository for all regulatory submissions, as well as a virtual workspace where different teams can easily and quickly revise the dossier.
Integration Helps Leverage Existing Systems. You can leverage your existing systems, such as ERP, PDM, and PLM, by integrating them with robust MasterControl applications without expensive custom coding.
Risk-Based Software Validation Offerings Help Reduce Compliance Burden. MasterControl offers a line of products and services designed to dramatically reduce the time, pain, and cost involved in software validation. Companies may choose the appropriate products and services based on their own risk assessment.
Flexible Approach Makes System Ownership More Cost-Effective. While mature companies typically prefer to purchase a full MasterControl suite outright, many smaller companies choose the application server provider (ASP) service for a minimal upfront cost. This approach allows fast deployment, offers software validation services, and requires no technical maintenance or special equipment. Companies may select an ASP system that is purely document management and 100 percent preconfigured. Or, as their needs grow, they may want more customization and additional applications (CAPA, change control, training control, etc.) to fit their requirements.
Conclusion
Time is a precious commodity for everyone, but especially for people involved in drug development. You can maximize development time starting with the way you control document-based processes. As this white paper has shown you, a delay in time to market due to poor document management is largely preventable with the help of the right solution
Article Source http://www.ngpharma.com/article/Issue-10/Manufacturing/How-Effective-Document-Management-Helps-Pharmaceutical-Companies-Accelerate-Time-to-Market/
Tuesday, June 2, 2009
2009 Review of Document Storage Systems
Document Storage Systems Offer Affordable Organization Tools
John Higgins, CPA.CITP
From the June 2009 Issue
Just like the white snow melting into green grass, our perennial review of document storage and document management solutions has become a key milestone in the transition from winter to spring and summer. What a great time of year! This also means we have completed yet another year of development efforts by the vendor community. The solutions they develop to help you take your accounting and tax practice “digital,” have become even more effective. So our mission in this review and the companion review of document management systems to be featured in the The CPA Technology Advisor in July, is to help you gain a better perspective of what many of the leading vendors have to offer and some of the enhancements they have made while you were busy laboring through another productive tax season.
In these reviews we continue to face the challenge of trying to appropriately categorize the solutions into comparable groups. That is much easier said than done because there are so many good solutions and the depth and breadth of functionality varies considerably. However, we have made our best attempt to provide meaningful comparisons by separating the reviews between document “storage” systems and document “management” systems. I’ll be the first to admit that the line that separates them is much grayer than it is black and white. So we’ll start by attempting to explain the differences between the two categories.
When we talk about document storage systems, think of these as software applications that are designed with the primary focus on managing the way you organize the storage of your electronic documents, as well as other application files from MS Office, Acrobat, etc. These systems are generally limited in their scope of features, which makes them very affordable for the small firm or sole practitioner, and better yet, quite easy to deploy and use.
In the July 2009 issue, we will review the more robust document management solutions that are designed to fulfill the needs of the entire firm. Document Management systems not only organize the storage of electronic documents and files; they also provide extended functionality to integrate with tax and accounting applications, and perhaps provide a portal component, workflow automation, document retention and more. We’ll provide an in-depth discussion of the features and functions of these systems next month. For now, our focus is on the more simplistic document storage tools.
Since these document storage systems tend to differ considerably in the nature of their functionality, we have rated them on four relatively broad attributes: user interface, file organization/management, integration with other software applications, and overall value based on the depth of functionality and pricing. We have almost a dozen products in this review, so let’s get started.
Article Source http://www.cpatechnologyadvisor.com/print/The-CPA-Technology-Advisor/2009-Review-of-Document-Storage-Systems/1$2354
Article Source http://www.cpatechnologyadvisor.com/print/The-CPA-Technology-Advisor/2009-Review-of-Document-Storage-Systems/1$2354
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