If you have worked with Documentum for a long time you may have noticed that this powerful behemoth has undergone quite a makeover over the years since Documentum 4i.  For me the major enhancements began with Documentum 5.3 which now has led to a very powerful but hopefully more user-friendly if not sleeker version of itself in Documentum 6.5. Let’s take a stroll down memory lane and revisit the key release changes over the years.

In 2005 Documentum 5.3 was released

This was a  major revision for Documentum. The 5.3 offering, was to use its next-generation enterprise content management platform that would draw together collaboration, search, and file management into one system for the first time.

Documentum 5.3 included a number of features.  It included:

• The EMC Documentum Client for Outlook which let Outlook users access all the features available in the traditional Documentum Web-based interface, so you could also save e-mails and attachments in a Documentum repository.
• And a new federated search capability would let make content searching in Documentum and other repositories easier.
• All the features were for the first time part of a single system. A unified stack could now federate formerly isolated content repositories offers benefits to business buyers.
• All content management applications would now share the same architecture with a common code base, security model, repository, object model, and API, meaning lower installation and administration costs plus unified audit trails.
• Documentum 5.3 also included new business and process services.
• Documentum Content Transformation Services shifted documents, images, and audio and video files from one format to another according to the application.
• Documentum Collaboration Services let information be shared through notes, contextual folders, discussions, and workspace rooms.
• And lastly, the EMC Documentum Business Process Engine allowed automation of tasks such as work assignment, prioritization and load balancing.

In 2007 Documentum 6.0 was released

• Web services — Documentum 6 extends its SOA (Service Oriented Architecture) architecture with a comprehensive set of industry-standard Web services that would provide a seamless way to access the Documentum capabilities in either Java or .NET environment.
• Ease of use — Documentum 6 Web clients would provide AJAX support, the new clients provided keyboard short-cuts, right-click support, and multi-object actions with no annoying check boxes. New configurability options could further simplify the user experience.
• Work anywhere — Documentum Client for Outlook wouldcome with offline support to allow people to work in a disconnected mode with subsequent intelligent repository synchronization.
• Collaborative content management — Documentum 6 platform included the collaboration capabilities of the eRoom product line embedded into the core Documentum architecture as well as an enhanced set of federated searching capabilities. The next-generation integration with SharePoint 2007 would be native to the Microsoft applications.
• Transactional content management — Documentum 6 platform would be the foundation for a new class of transactional content solutions, including optimization for scanned image management, significant performance and scalability improvements, comprehensive BPM suite, and a streamlined client interface designed specifically for workers within content-centric content solutions like loan origination and claims processing.
• Interactive content management — In Documentum 6, Web Content Management and Digital Asset Management would also have a new streamlined user experience.
• Tooling — Documentum 6 platform would support the Eclipse tooling environment and would unify the user experience for Documentum 6 administration, configuration, deployment, and development tools.
• Global scale — Documentum 6 would have significantly improved support for distributed environments including remote content appliances.

In 2008 Documentum 6.5 was released

With Documentum 6.5, Documentum enters the world of web 2.0.  It marries the web 2.0 user experience model with ECM capabilities. In this way Documentum ECM 6.5 extends the value of ECM to a much broader set of users.

The new features in Documentum ECM 6.5 that provide users with a the Web 2.0 experience include:

• Documentum CenterStage Essentials, a new client for knowledge workers. The completely redesigned interface is extremely easy to use and features shared team workspaces, guided search and simple Documentum access. I guess its meant to address those who prefer a Sharepoint style solution.
• Documentum Media WorkSpace, a new media interface which provides users a personalized, dynamic and familiar way to view, find, compare, annotate, review and share media assets.
• My Documentum, a new lightweight client that is completely integrated with the desktop providing users with immediate access to the latest versions of content they use most often as well as allowing them to access and work on documents when they are not connected to the server.
• Documentum Web Publisher Page Builder, a newly designed, Flex-based Web authoring interface provides non-technical business users and authors with an interactive and easy to use tool to create compelling Web experiences.
• An enhanced Documentum TaskSpace delivers a highly configurable, all-in-one user experience that combines content, process, high-fidelity forms and monitoring to accelerate business processes and substantially increase user productivity.
• 

In a down economy one of the first reactions that companies may try is to reduce their IT Operating Expenditures (OPEX) across the board. While this may bring down IT costs it may also bring down overall revenue over time. Studies conducted by Dr. Howard Rubin on 400 companies during the the 2001-2003 recession actually show that it is in a company’s best interest to optimize IT spending instead of merely cutting IT costs.

This approach is actually part of the Business Agility mantra. Companies that understand how to optimize their IT spending will be better able to achieve the agile business models they need.

The study found that winning companies applied the following six steps:

1. Optimize Costs – this doesn’t mean to just cut costs but to cut the right ones .This will help avoid short-sighted chopping of IT costs. This may actually mean spending on IT to cut total company operating expenditures.
2. Prepare to migrate to a variable cost operating model. This should provide better protection of operating cash flow since variable cost means total OPEX drops when revenue drops so company stays in the black instead of drifting into the red)
3. Increase Automation. This means to automate the routine and empower people to handle exceptions. It’s easier and cheaper to automate routine operations because they are routine/simple. It’s much more expensive to automate complicated exception handling. This is what people best anyway.
4. Identify and Focus on Key Customers. We all know the pareto rule that states 80% of revenue come from 20% of customers. Well these customers also tend to provide better profits. By focusing on customized value added product or services for these customers it may be possible to actually increase profits.
5. Market to Growth Areas. You will need to spend time communicating with and selling to key customers who need value added services you can provide and be prepared to let go of traditional customers who are not growing or are even dying and only looking for the lowest prices. You may not be able to make money with them anyways and they may end up bringing you down.
6. Invest when competitors aren’t. If you know what you’re doing and where you’re going, the field is yours for the taking. Proper product marketing and research may get you the advantage you need by being first out the gate.

So if you are the CIO or new CBO when the CEO and the CFO tell you to cut IT costs, maybe you should tell them that that might not be the best strategy and may even cause the company to lose market share and revenue. You can try telling them that a more effective strategy may be to work with fellow executives in using IT to cut overall company OPEX and to focus on revenue growth areas. And you may even be able to do this with IT solutions that require no CAPEX, that have variable costs, and provide scalable platforms to grow as the company grows.

If you want to know more details on how this is possible talk to a Business Agility Coach.

I came from the internet heyday when the user experience was trumpeted as the holy grail of application development. As a designer I worked under a head of User Experience and the UI was a key focus of many development projects. That has never left me. I still believe products that have distanced themselves over competitors usually have a User Experience advantage like Apple in its design of iTunes and iPhone.

If you look at the competitive SaaS market the winners over time will be those who focus on UI in regards to how it affects the User Experience. Central Desktop seems to understand this now. Originally although Central Desktop has been a good-value sharepoint alternative it has left something to be desired in the User Experience arena. It was a good value and its layout and flow felt like it at times. Well that may now be changed because over the weekend Central Desktop launched its redesigned user interface and made huge strides in User Experience. .

The product’s 2.0 version, employs new features that help make the user interface more intuitive, easier to use and follow the task flow. It has created some new wizards, templates, drop-down menus and layout customization options.

Intuitiveness has a lot to do with User Experience and that means not having to over think tasks that should be simple. The online file viewer now allows more file types, including Microsoft Office, Adobe PDF and Photoshop, JPEG and TIF. This is one of those things which make a big impact because after its introduced, people can forget about it. And that’s a good thing. In other words some features should be things that allows the user to take it for granted. PDF file viewing and conversion should be automatic because it is such a big part of tech tasks (from a tech user perspective) and the new tools in Central Desktop will help streamline the feel or flow.

As mentioned in other reviews Central Desktop may not be the right match for everyone especially for very large enterprises. But where Central Desktop really shines is in the advantage, value and now user experience it gives to companies between 100 and 1,000 employees.

This is just a quick first pass review of the new release. We invite others to share your experiences and review with Central Desktop. AVO Chief is looking for additional value-oriented product reviewers feel free to comment on this review or submit to us your own full review.

Your Company Needs Portfolio Management if…

• Million-dollar projects, which may or may not match the company’s objectives, are being awarded to business units headed by the squeakiest executives
• Your company currently has weak IT governance structures which means that business executives don’t have clear ideas of what they’re approving and why
• The CIO ends up selling projects that should be generated and sold by line-of-business heads
• If the company doesn’t build good business cases for IT projects or it doesn’t do them at all; and there are redundant projects.

A strong portfolio management program can turn all that around and do the following:

• Maximize value of IT investments while minimizing the risk
• Improve communication and alignment between IS and business leaders
• Encourage business leaders to think “team,” not “me,” and to take responsibility for projects
• Allow planners to schedule resources more efficiently
• Reduce the number of redundant projects and make it easier to kill projects

There’s no single right way to do IT portfolio management. Vendors, consulting companies and academics offer many models, and often companies develop their own methodologies. Off-the-shelf software is available from a variety of vendors such as CA Clarity PPM and HP PPM to name a few. But there are plenty of hurdles to doing it well. There are, however, some key logical steps that should be considered.

Here are the key steps in creating and managing your IT investment portfolio.

1.  Gather: Do a Project Inventory

Portfolio management begins with gathering a detailed inventory of all the projects in your company, ideally in a single database, including name, length, estimated cost, business objective, ROI and business benefits. Usually, the first task of program management is getting control of project portfolio activities. That means creating an inventory, put that into a master project schedule, gain an understanding of the resource requirements of all the projects, then do a reconciliation of the projects and reduce the schedule to a manageable level.

Creating a project portfolio inventory can be painstaking but is well worth the effort. For many companies, it may be their first holistic view of the entire IT portfolio and any redundancies. A good inventory is the foundation for developing the projects that best meet strategic objectives.

2.  Evaluate: Identify Projects That Match Strategic  Objectives

The next steps involve establishing a portfolio process.

• The heads of business units, in conjunction with the senior IT leaders in each of those units, compile a list of projects during the annual planning cycle and support them with good business cases that show estimated costs, ROI, business benefit and risk assessment.
• The leadership team vets those projects and sifts out the ones with questionable business value.
• Next, a senior-level IT steering committee made up of business unit heads, IT leaders and perhaps other senior executives meets to review the project proposals; a good governance structure is central to making this work.

One of the core criteria for which projects get funded is how closely a project meets a company’s strategic objectives for the upcoming year. At some companies, an executive leadership team will create five or so strategic initiatives, such as CRM for example. The IT governance council, made up of business leaders and senior IT leaders, then evaluates projects based on how well they map against those initiatives. Other evaluation factors can be based on risk, change management, resources, etc. We suggest using a methodology like the AVO method that borrowed from the product development arena.  In the end projects that are placed above the line are those that should be funded. Those that are below the line are those that shouldn’t.

Some project portfolio review boards also evaluate one-page project opportunity assessment for every proposal. A good evaluation process can help companies detect overlapping project proposals up front, cut off projects with poor business cases earlier, and strengthen alignment between IS and business execs.

3.  Prioritize: Score and Categorize Your Projects

After evaluating projects, most companies will still have more than they can actually fund. The beauty of portfolio management is that ultimately, the prioritization process will allow you to fund the projects that most closely align with your company’s strategic objectives.

Some companies may like their projects to be pooled together as like projects. For example, some groups may be:

• Large technology projects
• Small technology projects
• Infrastructure technology projects,
• Possibly one covering executive initiatives.

In the case of the large tech portfolio, its management team made up of project sponsors, function managers (for example, representatives from engineering, financial services and operations) and product portfolio managers (people with long-term project leadership responsibilities) vet projects and come up with a list of a specified number of projects for the portfolio team to score. They then prioritized them using a model that has four key tenets:

• Identify four to seven strategies. (for example, limiting technology risk, increasing the reliability of the infrastructure).
• Decide on one criterion per strategy. For example, the team can decide that the criterion for limiting technology risk would be whether the technology had been implemented in a comparable organization and that the benefits could be translated to their organization easily.
• Weigh the criteria.
• Keep the scoring scale simple. For example you can use a scale of one to five. For the technology risk strategy, five might mean that it has been used in a comparable organization and the benefits could be transferred easily; three could mean it’s hard to do because it would require changing processes; one might mean they haven’t seen it work anywhere else.

Following the scoring, the team can draw a line based on how many projects it could do with existing resources.

In the case of the large technology portfolio, the line can be calculated where demand (the list of projects) meets supply. Those projects above the line could be done in that year. The team then can present that list to the committee or council, which can approved it that same day instead of , weeks.

There is no one method to categorize your IT investment portfolio. One approach is to categorize it as you would your own financial portfolio, balancing riskier, higher reward strategic investments with safer categories, such as infrastructure. One suggestion is to divide a portfolio into three investment categories:

• Running (keeping the lights on),
• Growing (supporting organic growth) and
• Transforming the business (finding new ways of doing business using technology).

Those categories can then be cross-tabulated with four to five value-focused categories, such as how those investments support revenue growth, reduce costs or grow market share.

The payoffs that come from a thorough evaluation and prioritization process is the primary reason portfolio management is so effective. Here is list of the some of the benefits:

1.       First, communication between IS and business leaders improves. And portfolio management gives business leaders a valuable, newfound skill – the ability to understand how IT initiatives impact their companies.

2.       Second, business leaders think “team,” not “me,” and take responsibility for projects. One tried-and-true method for how a business leader got money for his unit’s projects was to scream louder than everyone else. Portfolio management throws that practice out the corner office window; decisions are made based on the best interests of the company.

3.       Third, portfolio management gives business leaders responsibility for IT projects. So the businesspeople propose the projects and [take responsibility] for risk profiling, ongoing operational costs and timeliness of delivery.”

Finally, everybody knows where the dollars are flowing and why, which is especially important to CEOs, CFOs and CIOs who are increasingly demanding that technology investments deliver value and support strategic objectives.

4. Review: Actively Manage Your Portfolio

The portfolio must be actively managed following approval of the project list. Doing that involves monitoring projects at frequent intervals, at least quarterly. At many companies a PMO that reports directly to the CIO has that responsibility. Once or twice a month, the project management office gets financial and work progress perspective updates from project leaders. That information goes into a database, and the CIO reports to the entire company monthly, giving the project inventory and its status. He assigns project status:

• Green (good)
• Yellow (caution)
• Red (help!)

He also includes an explanation of the key driver causing a yellow or red condition. The IT steering committee meets once a month to make decisions to continue or stop initiatives, assess funding levels and resolve resource issues.

Frequent reviews allow the committee to redirect resources more quickly. Monitoring project portfolios regularly also means projects that have run off the rails can be killed more easily. For example, if there’s a strategy decision to focus on a certain ERP like SAP, then it makes sense to cancel a new system that interfaces with PeopleSoft.

Its always a challenge when you are trying to create a solution from scratch.  Like my Linksys by Cisco, CIO mentor Tim Good once said “You try to buy before you build”.  The reason is that if a business builds new solutions for all its issues, that company may not be able to focus on their core business because they have to spend time maintaining  and updating more code.  Unfortunately even though that approach is clear there is not always a clear Off-The-Shelf solution at that time.  This was the case when we were challenged with developing a .Net custom Sales Quoting  application to integrate with Salesforce.com. We were able to successfully design and develop a pilot application. But just a year later Big Machines Inc., an on-demand sales configuration and proposal software, announced that it was developing a new native application on the Force.com platform from salesforce.com.  The new application would enable sales teams and channels to easily generate professional sales documents from within a Salesforce CRM opportunity.

Using the new BigMachines application, sales reps would be able to add products and quotes to opportunities and manage pricing and discounts. System administrators would be able to build templates for sales documents, such as proposals, quotes and contracts, using BigMachines Document Engine, and publish the templates to sales reps, who select their selling documents from within their familiar Salesforce CRM interface.

Regardless of what solution you choose here are some key process steps  to consider for implementation.  The key focus is process improvement and reduction of waste and causes of errors with a drive toward continuous improvement.

• You should begin by doing a gap analysis of your sales process.  Try to map the process starting from the customer backwards all the way to product manufacturing.
• This is a good time to get feedback from customers and sales people as to what the pain points are in the current process and where improvements could be made.
• Take a snapshot of your current systems and sales tools and how they support your quoting, ordering, and customer service processes.
• Design the “To-be” state of your sales process and then see where technologies (web) would have the greatest value impact in the process. A key focus is to reduce areas of waste such like paper processing, data re-entry, and faxing.  These are definite areas where web technologies can help to eliminate waste.
• Establish key metrics that will be used to measure success of the project.
• When setting up the project plan set up clear roles, responsibilities and include Rapid Prototype tasks and milestones so that pilot users can get in their feedback in an efficient manner.  Try to involve as many different user types as possible (customers, distributors, sales, engineering) so as to get as much feedback and possible concerns early so the final solution can be tailored appropriately before a broad rollout.
• After launch, continue to track metrics to measure success and drive continuous improvement.

There was a time when the majority of IT tasks were kept in house but today even network security tasks can be handled by outside vendors. So obviously the potential of losing control of a project handled by an outside vendor is a very real possibility. These problems can be especially frustrating to the project’s leadership. This doesn’t have to be with a little bit of planning and follow-through. For example, attention to creating and executing a well thought out contract can make all the difference in asserting the control needed to be successful.

Here are some key areas to keep in mind:

• Whenever possible, include terms and conditions in the contract the delineate how the vendor can be rewarded if it completes the contract early, but penalized if it completes late.
• Whenever possible, include terms and conditions in the contract that delineate how the vendor can be rewarded if it delivers a higher quality product and, but penalized if it delivers an inferior quality product.
• Have a project plan prepared by the project manager (preferably yours) and have the vendor provide progress reports against that plan each week.

Things to watch out for:

• Key skills that might disappear when from the project and follow-on projects when the vendor contract completes.  Make sure your company brings on skilled workers to work alongside the vendor at the appropriate times so that there is a valuable transfer of knowledge
• Vendor employees that do not perform as expected. Make sure that this is addressed in the contract.
• Key vendor employees may be switched to other vendor projects midway through yours thus putting your project at risk. Make sure that the contract requires certain vendor employees to participate full time on the project.  And if possible, the contract should forbid the vendor from changing assigned employees without your company’s consent after the  contract’s been signed.
• Being left with absolutely no vendors resources after the contract is complete.  Make sure you negotiate the possibility of a retainer fee with the vendor.

Due to the power and flexibility of the Salesforce.com tool, understanding the role it will play in your organization is the most important piece of a successful implementation.  This is where the skillful use of business analysis can be invaluable.

Salesforce.com is a powerful and flexible tool that can be combined with partner applications to become the primary application for your business.  Salesforce.com can also be implemented to simply support sales force automation, call centers or marketing.  So properly determining the scope of the implementation and defining the success measures will help to ensure a successful implementation.

A business analyst should be used in your organization to ensure you are using Salesforce.com effectively.  This business analyst can serve as an advisor and can become an important extension of your organization and the primary point of contact for your Salesforce users.  The business analyst should learn the goals of the organization and help develop and document a clear vision for the use of Salesforce.

A Salesforce.com implementation project may involve implementation, modification, integrations, customizations and support of the Salesforce.com instance.  It is important to define and document the unique requirements of the business and develop a specific plan to address those requirements.

The business analyst may also analyze the selected Salesforce configurations and make recommendations on best practices and process improvements specifically for your business.

For example, in a typical implementation there are hundreds of questions that should be answered before any users are given access to the system or any data is loaded.

Below is a short list of high level questions you should have the answers to before beginning any implementation:

Users

• Who should have access?
• Will our hierarchy in Salesforce.com reflect our organizational hierarchy?
• What should each user have access to?
• Should the application display different data for different users?

Accounts

• What is our company definition of an account?
• Who will own each account?
• What will the sharing rules be?
• What is our system of record?
• What accounts will we load into the system?
• Who can create accounts?
• What fields are required and when?
• What custom fields do we need?

Contacts

• Who will own each contact?
• What will the sharing rules be?
• How will we record activities with contacts?
• What custom fields do we need?

Opportunities

• What is our sales process?
• How many sales processes do we have?
• Should we associate products with opportunities?
• What fields are required and when?
• How do we track competitive information?
• What custom fields do we need?

Products & Price Books

• How many price books should we have?
• Should our products in Salesforce.com be integrated with our finance system?
• Should we use list price?
• How do we handle discounting?
• What custom fields do we need?

Forecasting

• How will we do forecasting?
• Will we forecast bookings, revenue or both?
• What organizational level will we forecast at?

Reporting

• What reports are available?
• What reports do we need?
• Who needs access to the reports?
• How will we distribute reports throughout the organization?

Of course, this is just a small, sample list of questions.  There are hundreds of additional questions related to campaigns, customer support, document management, lead management, and analytics.

Furthermore, since organizations and processes change frequently due to growth, management turnover, mergers and acquisitions, and restructuring your Salesforce.com implementation will need to keep up with the changing needs of the business.

A typical business analysis may include the following deliverables:

Interviews

• Executive Sponsor(s)
• Stakeholders
• Users

Vision & Scope Document

• Vision / Goals
• Business Needs
• Scope of Implementation
• Success Measures

Requirements Document

• Business Requirements
• Technical Specifications
• Application Settings
• Customizations Needed:  e.g. Data migration controls to improve data quality (reduction of outdated and duplicated data, etc.) and Transfer of legacy data
• Reports Needed
• 3rd Party Applications / Integration Needed
• Custom Software Development (if necessary)
• Training
• Support

A thorough business analysis can be the cornerstone to a successful Salesforce.com implementation.

Validation

A unique and very important part of the Life Sciences development lifecycle is validation. Validation requires documented verification that a process will produce accurate results as per the predefined specification. For this to work you need to know in advance that what you describe will function as detailed. And there are usually plenty of details to cover. In fact, validation impacts practically every area and phase of an automation project for life sciences companies.

Most companies base the engineering effort required to create validation protocols and documents on the GAMP guidelines. These documents incorporate the requirement, design, implementation and test and verification phases. The documents that make up these phases will ensure validation compliance of the completed system implementation.

They usually include at least some of the following:

• User Requirement Specification
• Design Spec
• Functional Specification
• Technical Specification
• Coding Review
• Unit Testing
• Component Testing
• System Testing
• Systems Testing
• User Acceptance Testing

Let’s face it, for some companies the role of the CIO driving business really doesn’t make sense.  Don’t get me wrong I am not saying that the CIO role is going away.  But according to CIO magazine the role of the CIO seems to be changing. It was like riding a business wave that may have peaked.  What many companies seem to need now is not just an IT manager that can speak business but a business manager that can speak product and technology. Remember that for the most part many company org charts have not changed over the years.  Because of a need for quicker solution and agility it was thought that IT may be the solution.  The only problem is that in order to grow business much more than technical knowledge is needed. A balanced skill set is needed to provide the vital business agility that product companies need.

You see business agility comes from several areas. Here are the key areas:

• Market Research/Marketing
• Analysis
• Development
• Business Strategy

So you see although technical knowledge is important in order to drive business agility, this era’s C-level executive will need to have a good understanding of core product functions like market research, analysis and business strategy.  This is not to say it is not possible for a CIO to accomplish but rather that for many an IT background by itself may not be enough to bridge the business/IT divide.  In other words a new position may be needed that works tightly in conjunction with the CTO, VP Finance and VP-Sales & Services.  In fact, some schools of thought are suggesting that for larger companies the CIO really requires a handshake from a C-level business partner for maximum benefit (much like paired programming in the Extreme Programming Model).  I will expound on these reasons in a later article.  So what most companies really need now is a new central position for a Chief Business Agility Officer (Product and/or Services) or CBO for short in order to survive the challenges to come.

Why do I say this?

Well you see many companies become dysfunctional when it comes to defining, building and delivering products? Many organizations have marketing and R&D as separate entities and they sometimes just do not play nicely together. And in hard times rather than work together these departments may go into turf protection mode. And since product managers have to work with both they often bear the brunt of all this as they try to get products and releases out the door.  But it doesn’t have to be this hard.

If you are in a product-driven company where the business model for generating revenue is driven by defining, building and selling products or if your company is transitioning into a product-driven company, then your company can definitely benefit from a dedicated Chief Business Agility Officer.  Why don’t I call this a Chief Product Officer?  One reason is that while it would primarily aid product companies this re-organization can apply to certain services companies as well.  Secondly, “product” never really conveys the importance of this position.  What the desired result of this position is business agility and therefore continued business survival and growth.  The Chief Business Agility Officer will need to align both business and IT goals and resources.  This can be done by training key staff on business agility known as the AVO Method. Although future CBOs may come from the ranks of product managers they need to be able to deal with issues at the C-level in order to do major cost and resource re-alignment effectively and in order to be competitive.

To be more specific I will expound the 3 major key areas for a product-driven company.

• Finance and Corporate Services – makes sure that everything is in place and operating properly.
• Next is Sales and Services (if Services apply) who are responsible increasing revenues from new and existing customers; whether it is direct, indirect, online, telesales, etc.
• And last (but not least) are the activities around finding markets, defining and building solutions to address market needs and supporting customers. This needs to be clearly focused on Product Management.  But for many companies these critical activities are split between Marketing and R&D.  Why? Shouldn’t the managing of the product portfolio be one of the most important activities in a product-driven company?

So we need to view the org chart from this perspective. I suggest that standard org charts for companies that view the activities of defining, building and delivering products as paramount be redrawn to include a new role – the role of  CBO  - Chief Business Officer.

An important consideration in evaluating the impact of  FirstDoc/Documentum-based applications in helping meet 21 CFR Part 11 compliance is whether the specific system implementation is considered a closed or open system.  The FDA provides the following definitions in 21 CFR Part 11 for closed and open systems:

• Closed system means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.
• Open system means an environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system.

Closed System Controls

For closed systems there needs to be a way for “validation of the systems to ensure accuracy, reliability, consistent intended performance and the ability to discern invalid or altered records”.  FirstDoc has been developed in accordance with an ISO 9001:2000 certified Quality Management System. In addition, FirstDoc has been audited by many pharmaceuticals and performed well.  This by itself is not a guarantee but an indication that many of its features were built with 21 CFR Part 11 compliance in mind.

Ability to Generate Records

For example, FirstDoc works within a Documentum environment.  Documentum along with company records management policy help satisfy the requirement to be able to generate accurate records both in human readable and electronic form suitable for inspection and review.

Features that support accurate and complete copies in human readable form include:

• The generation of PDF renditions
• The ability to view and print these renditions in accordance with system-defined security rules
• FirstDoc’s automatic PDF rendition generation feature where each time document is modified FirstDoc generates a PDF rendition (if so supported)

Protection of Records for Retrieval

• Documentum’s built in archiving capability  can be used to migrate content off-line while maintaining metadata in the docbase.  Therefore, documents can be retained in the system throughout the retention period, or in an archiving process where they are stored outside the system.
• FirstDoc uses Documentum’s robust security, which limits the capability for modifying and deleting records to designated users.
• FirstDoc also automatically applies security to Approved documents that prevents them from being deleted or modified.
• FirstDoc can track retention information to assist in managing documents in accordance with retention policies.
• FirstDoc also includes an optional Records Management module which implements retention policies and allows deletion of records which have reached the end of their retention periods.

Limiting Access to Authorized Individuals

• Documentum implements a secure username and password to limit access to authorized individuals
• FirstDoc augments Documentum security by providing automatic application of a client’s defined security scheme. And users cannot modify security outside of the rules defined.

Use of Secure Audit Trails

• FirstDoc uses the Documentum audit trail capability augmented by audit trail entries produced for custom FirstDoc events such as check-in, save, destroy, status change and user events such as review and approval outcome including electronic signature
• Unless the audit trail has been migrated offline as per a controlled SOP, Documentum’s Purge Audit Trail capability should not be used in order to maintain the audit trail for the life of the record.
• FirstDoc provides the capability for authorized users to change document metadata on approved records. And an audit trail entry captures the previously recorded values so that they are not obscured.

Use of Operational System checks

Documentum can aid in implementing many of the following controls:

• Use of approved templates only in creating documents
• Limiting property values to predefined lists wherever possible
• Entry of mandatory attributes
• Storage in a pre-defined hiearchy (cabinet/folder structure)
• Enforcing a defined document lifecycle and approval process
• Ensuring that all required electronic signatures are obtained.

Use of Authority Checks

Documentum can aid in implementing client-defined control over authorization for the following:

• Document creation
• Document access (delete, write, read, etc. via ACL security)
• Changing status
• Initiating and participating in the review and approval process
• Signing documents
• Establishing document relations

Electronic Signature Records

Electronic signatures required additional information that validates the signature.

• FirstDoc validates the signature, translates the user ID to the full user name, and captures the user name, local date an time, server date and time and reason for signature as non-editable properties of the document.
• FirstDoc will imprint signature pages and screens with the time zone reference selected.
• FirstDoc adds a signature page to the document PDF that displays all required signature information, including full name of each user who signed the document.
• Electronic signatures must be unique to one individual and must not be re-used. Documentum can assist with this via the ability to disable (and not delete) users who are removed from the system. By leaving the users in the system re-use of their user IDs will not be possible.

Code and Password Controls

• Documentum and Unix/Windows Server system can provide the ability to maintain uniqueness of code and password so that no two individuals have the same combination of code and password.
• Both Trusted Unix and Windows server system can be used as well to require periodic aging of passwords.
• Both Trusted Unix and Windows server system can be used to disable user accounts after a configurable number of unsuccessful attempts.