April 9, 2015

Inspiration and Staying Positive

Posted in Inspiration at 9:07 AM by Solutions2Projects, LLC

I have been collecting inspirational quotes and have put them on the wall in my office (and on FB) so I can look at them regularly and share with others. We are bombarded with negativity and I know I need frequent doses of positivity. I thought I would share some of my favorites. Where possible I have credited the source. In some cases, I simply wrote them down on slips of paper, taped them to my wall and have no idea where they came from.

“The only way to be great is to love what you do.” Steve Jobs

“Expressing your true self is not an option; it’s a must. Be original.” Unknown

“Success is doing what you want, when you want, where you want, with whom you want, as much as you want.” Unknown

“Don’t squander the gold of your days, listening to the tedious, trying to improve the hopeless failure, or giving your life away to the ignorant, the common, and the vulgar. These are sickly aims, the false ideals, of our age. Live! Live the wonderful life that is in you! Let nothing be lost upon you. Be always searching for new sensations. Be afraid of nothing.” Oscar Wilde, Picture of Dorian Gray

“Challenges are what make like interesting; overcoming them is what makes life meaningful.” Joshua J. Marine

“Life is like a camera. Just focus on what’s important. Capture the good times. Develop from the negatives. And if things don’t work out…just take another shot.” Unknown

“Be strong when you are weak. Be brave when you are scared. Be humble when you are victorious. Be badass every day.” Unknown

“Risk more than is required. Learn more than is normal. Be strong. Show courage. Breathe. Excel. Love. Lead. Speak your truth. Live your values. Laugh. Cry. Innovate. Simplify. Adore mastery. Release mediocrity. Aim for genius. Stay humble. Be kinder than expected. Deliver more than is needed. Exude passion. Shatter your limits. Transcend your fears. Inspire others by your bigness. Don’t stop. Change the world.” Unknown

“Welcome chance encounters and opportunities to dream up outlandish plans.” Richard Branson

“We can let the circumstances of our lives harden us so that we become increasingly resentful and afraid, or we can let them soften us, and make us kinder. You always have the choice.” Dalai Lama

Every day we have the opportunity to choose how we are going to be in the world. I use these types of quotes to inspire me to be a positive influence in the world and in my own life. How do you stay positive and focused?

March 10, 2015

Learning

Posted in Learning tagged at 7:25 PM by Solutions2Projects, LLC

I am driven to learn and grow more out of fear than a desire to change. I fear mediocrity, complacency, becoming redundant, and dying (from flying). I am rarely disappointed when I take on a new education challenge and often get something unexpected out of it. I was fortunate to have the opportunity to participate in a number of learning experiences recently and move beyond my fear.

One of my best friends invited me to attend a seminar for female entrepreneurs in SF (Grow at the Well). Typically I am not a fan of these events as they provide more hype than substance. The speakers were interesting but both of us felt that their stories were not entirely relevant to us. We are both opportunists and concentrated on finding the hidden gems in the stories and the overall experience (besides a day in SF together) and came away with a few. On our way home, we talked about what we had gotten out of the day and how we could apply various things to our own businesses and provided each other with some valuable insight. This was by far the most beneficial part of the day. We had made space for the discussion using the events of the day as a springboard for the conversation. That was truly a luxury and extremely rewarding (and unplanned).

Another friend encouraged me to check out coursera.org for some free, online classes. I figured this was a low risk endeavor and opted to take a class on philosophy in business. The presenter was very good (and French which is always a plus), the topic interesting if not directly relevant, but the course structure was by far the most intriguing of all. I am now curious to see how other service providers structure their online courses and if this can be a place for me to offer IT project/IT strategy related education courses. In this particular case, I got out of the learning something totally unexpected…a service offering opportunity.

Currently, I am working towards my commercial helicopter rating. In March 2009, I achieved a private rating and over the years, I managed to narrow the scope and frequency of my flying so much that I didn’t feel as safe or as competent as I would have liked. Giving up flying was not an option so I needed to find a way to be a better and safer pilot (flying is a hobby after all and I need to mitigate the risks). I opted to pursue my commercial rating as I need a quantifiable goal and ‘being better’ was far too subjective.

This has required time hitting the books preparing for the written exam and time in the helicopter refining skills and developing new ones. As it was with my private, it’s been a lot of hard work but well worth the effort. I am weeks away from my check ride (which also requires book time and flight time), with the written exam and the required hours under my belt, but that seems almost unnecessary at this point. The goal was to become a better and safer pilot (as I have to remind myself) and at this point, that goal has been achieved and I am much more confident in my abilities in the cockpit (the commercial rating will be an added bonus of course). The confidence that I have gained through this process is pervasive and has been an unexpected pleasure.

I recently participated in a legal continuing education webinar on SaaS contracts with another best friend who is an attorney. We watched it together (yes there was wine involved) which was really great because she was able to provide the legal perspective and I was able to provide her with a practical, IT perspective. Oddly enough, it was a lot of fun. The topic was of interest to both of us as we both had significant experience with these types of contracts. I most appreciated all of the things that reinforced what I had been doing and also appreciated the new nuggets of knowledge that I can apply with the next contract review and negotiations. No certificate suitable for framing or degree required to benefit from (or reward) the experience.

Far too often we get so caught up in our daily activities or projects that we forget to see what else is out there to expand our knowledge, adjust our perspectives, reinforce what we do know, highlight areas of opportunity, and leverage existing and valuable resources.

So, take some time out of your busy schedule to enlighten your brain and enrich your life. You don’t know what is out there (or in you) until you take the time.

May 17, 2013

Biennial Checkup: Is NetSuite Ready for Life Sciences Companies Yet?

Posted in Cloud tagged , , , , , , at 2:24 AM by Solutions2Projects, LLC

The number of ERP/MRP systems available to my SMB life sciences companies is pretty limited especially if they require process manufacturing functionality.  With more biotech companies choosing to be virtual and outsourcing to contract manufacturers (CMOs) and third party logistics companies (3PLs), the process manufacturing piece becomes less important so long as there is light recipe functionality to provide traceability when converting from one item (i.e. API) to another (i.e. bulk product).  This includes providing lot data such as expiration dates and lot statuses as well as electronic records and electronic signatures compliant with 21 CFR Part 11.

I had the opportunity to take a look at the latest offering by NetSuite at SuiteWorld in San Jose this past week.  It’s hard to avoid the billboards on 101 and the CFOs who hear about it and think they must have it for their respective companies.  Even a local, high-flying biotech was tempted but realized quickly that it didn’t meet the requirements.   I last looked at it two years ago and quickly realized then that not only was it not appropriate for most of my clients, but it was barely compliant with Sarbanes-Oxley requirements as well.

Some very smart and generous gentlemen at ERP Guru (http://erpguru.com/) not only showed me the software but talked through how it could handle some of the processes that are typical for my clients.  I scratched out a typical product flow along with data requirements and within the manufacturing offering, it appears that the assembly functionality could potentially be used.

Where it fell apart was with the lot control functionality.  Fields can be created to support the lot control elements but custom scripts would need to be written to perform such critical functionality as to ensure expired product wasn’t allocated to a manufacturing run.  There were other similar examples that led me to the conclusion that it’s just not there yet for life sciences.  Once custom scripts have to be written to meet basic, critical functionality, not only are we into a different GAMP5 software categorization from a documentation and validation perspective (which requires greater rigor and effort that my clients really can’t support or afford), but you begin to introduce complexity in ensuring the custom functionality actually makes good business sense.

Just as when I reviewed Microsoft Dynamics SL for a small biotech company and discovered within 20 minutes that the lot functionality was not there, it was the same with NetSuite.  Once I saw what wasn’t there, I stopped looking at the product.

This isn’t to say that NetSuite isn’t interested in working on meeting the requirements.  I met with an account executive and reviewed some of the basic requirements and what we typically look for when selecting ERP/MRP systems.  She seemed genuinely interested and I’ve committed to providing requirements and some case studies from other ERP/MRP implementations to help her put a case together for improved functionality in future releases.

Although I am generally opposed to cloud-based solutions for
critical systems such as financial, SCM, manufacturing, among others from a control perspective, it’s not something that can be ignored.  My clients have small or outsourced IT departments and really aren’t interested in hosting things in house which means they need externally hosted or SaaS solutions.

My hope is that NetSuite is interested in the SMB life sciences vertical and enhances their product not this year, but by the time I go back to SuiteWorld in another two years.

September 20, 2012

Chickens and Change

Posted in General tagged , , , at 1:05 PM by Solutions2Projects, LLC

When you wake up at 5:45 AM to the sound of screeching chickens and realize that you forgot to put the chickens into the coop the night before and raccoons have discovered this oversight, perhaps it is an omen for what the day will become. 

I should have counted my blessings (after counting the chickens) and called it a day. 

But, no, I opted to feed the four girls some special treats, apologize profusely to them, rake up the feathers from the lawn to minimize the evidence (thank goodness they have multiple layers), and spend an hour catching up on the blogs and news sites I subscribe to on Pulse.  Not necessarily an uplifting experience with all of the sour financial news and political acrimony but educational nonetheless. 

By the time my daughter climbed into bed to cuddle with me at close to 7 and my husband delivered my daily cappuccino, I felt ready to face the day and whatever challenges and opportunities were going to present themselves.

Today has been a day filled with challenges (which of course always offer up opportunities for growth and learning).  I’ve decided that any instrument that is connected to a PC with a USB to RS-232 serial cable needs to be scrapped!

When a series of things do not go right in a period of time, and after I’ve attempted to force my way through said issues, at some point I come to the conclusion that perhaps perseverance is not what is required.  Perhaps it is time to step back and look at the situation from a different perspective to get a better sense of what is really going on.

That’s usually when I go flying or out for a run or hit a tennis ball really hard.  When that doesn’t work, I call my executive coach.  Sometimes I get too caught in the trees and need someone else to look at the situation from their vantage point in order to adjust my own frame.  Sometimes it’s just a tweak and other times, what’s required is a paradigm shift. 

The universe provides me with nudges or gentle reminders that may or may not go unnoticed.  After a while, the universe gets a bit impatient and provides some less subtle reminders.  While the chickens were a gentle nudge, a number of other not so subtle hints have been coming my direction and I’ve been noodling over them. 

It seems somewhat appropriate that now that I’ve been consulting for seven years (applies to marriages and other aspects of life it seems) it may be time to look in a new direction professionally…nothing so drastic as quitting my job to stay home with kids and be PTA president (we’ll leave that to my husband) but perhaps a different industry or a different type of consulting, leveraging my 20+ years of professional experience. 

So what started as a day filled with screeches and feathers has turned into a time for reflection (in between failed protocol tests).  Well, universe, I am just about ready…just let me get the feathers out of my hair.

August 23, 2012

Filters

Posted in General, Uncategorized tagged , , , at 9:44 AM by Solutions2Projects, LLC

Last year I took my son to a leadership training program for kids presented by Jim Wiltens.  Jim offers corporate and academic programs (per his website) and we had the opportunity to participate in a four week parent/child program at a local school.  The program was on Wednesday nights from 6:30-8:30 which was pretty tough after a long day at work and I often felt that while there was some good material in the program, that it was a sales pitch for his summer camp for kids in the High Sierras (which appeared to work as my son did attend a two week session this summer).

One of the things he covered during the class had to do with filters.  No, not camera filters or pool filters but the filters through which we observe things that happen and pass us by in life.  Jim encouraged the kids (and parents) to write down all of the things they want to do in their lives, both big and small, and create what one might morbidly call a bucket list.

The reason for this was that when you write something down it becomes more concrete and real.  And by doing so, you start to pay attention to things in life a bit differently.  Where you might not have noticed something before, you now might notice it because you have adjusted your filters.

We’ve all heard the example of when you buy a new car, let’s say a red BMW, all of a sudden you notice all of the red BMWs out on the road.  Or when you are expecting a child, all of a sudden all you see are pregnant women and babies.  This is because your filters have changed.

While my son wrote down his list in a brand new journal as part of his assignment, unfortunately, he hasn’t revisited the list to remind himself of what he wanted to do.  I, on the other hand, have revisited my list to remind myself and keep my filters adjusted.  It is so easy to fall back into complacency and the day to day routine and forget about other things you want to do.

So, give it a try.  Start writing down some of your dreams, no matter how big or small, in a journal or your iPhone.  Revisit the list daily or weekly (without stress or pressure) and see what starts to appear.  Perhaps you notice a posting for a French tutor at a local coffee shop or learn about an apartment in Paris not advertised through normal channels…things you wouldn’t have noticed if you hadn’t written down a goal to live in Paris for an extended period of time.   Á bientôt!

August 16, 2012

Recreating the Wheel

Posted in IT tagged , , , , , at 1:22 PM by Solutions2Projects, LLC

I love documentation and I won’t apologize for it.  Documentation saves time and leaves space to think through the tough issues. 

In IT, documentation is often a four letter word because documentation  isn’t as much fun as playing with technology.  I understand this. 

But, how often have you had to rethink a process or fumble through something that you haven’t done in a while?  How much time was spent on this that could have been reduced if there had been a specification document or work instruction?  What about when key personnel leave and they take their knowledge with them?

Recently I worked with a client on a system that I hadn’t touched in over two years.  Fortunately, I had documented the process and had a work instruction for it and was able to quickly answer the question and address the issue.  If I hadn’t, we would have had to contact support, wait on hold to get through two to three levels of support to get to the answer.  This was assuming it was during the right support hours. 

Another client is struggling to recreate processes performed by technical personnel who have left the company. And, because it was a small IT department, this person was solely responsible for performing some technical tasks and didn’t write anything down.  We are now in the process of starting from scratch to figure out how to get the work done with, of course, a very short timeline. 

The extra time it takes during an initial project implementation to document the system, configuration, and work instructions is less expensive and less time consuming in the long run and not nearly as painful as one might expect.  The documentation doesn’t  have to be formal or complicated; it just needs to impart the necessary information so that others do not have to recreate the wheel.

March 27, 2012

Know Your IT Systems Vendors

Posted in Cloud, Computer Validation, IT, Vendor Audits tagged , , , , , , , , , , , at 9:38 AM by Solutions2Projects, LLC

IT systems and infrastructure are critical to any organization.  This is especially true for life sciences companies selecting and implementing IT systems critical to the business functions supporting compliance functions. Regulatory bodies expect life sciences companies to demonstrate control over these elements regardless of whether they are the ones developing or maintaining the IT systems (infrastructure, software, etc.).

Companies cannot simply toss the responsibility over the fence to the vendors. Life sciences companies are still responsible for the integrity of the data and control over the systems.  They may delegate but only after verifying the vendor can meet the compliance and control requirements. 

This is where vendor audits come in to play. 

Vendor audits for software are not new.  Over the past decade I’ve seen the importance of vendor audits for software wax and wane and wax again.  In light of the increase in cloud and hosted solutions chosen by companies to decrease overall spend, the need for vendor audits is critical.

And, as biotechs become more virtual and more services are outsourced (CRO, CMO, data management, complaint handling, etc.), it is imperative that companies verify their vendors meet compliance requirements as well as their own procedural and process requirements.   The vendor’s IT systems and controls must meet the requirements as if they were hosted by your own company.  Not all vendors perceive the need to meet compliance requirements at the same level and you need to know before you enter any agreements.  Once you’ve signed the contracts, you’ve lost your leverage for process improvements and controls. 

Why conduct the audits? 

  • Gain high level of confidence that the computerized system will meet technical, commercial and regulatory requirements (GAMP 5)
  • Confirm the supplier builds quality and integrity into the software product during development
  • Leverage knowledge, experience and documentation of supplier (GAMP 5) to potentially reduce validation effort
  • Confirm processes and controls when  outsourcing IT / software functions (SaaS, PaaS, IaaS, hosted solutions, co-locations)

When should audits be performed?

  • For high risk systems / outsourced services
  • Before any contracts are signed!
  • Scheduled follow up audits based on
    • Audit results
    • External audit program
    • Risk assessment
    • Significant vendor business changes
    • When there are issues with the vendor

How are audits performed?

  • Similar to other vendor audits for CMOs or other critical suppliers
  • Plan for the audit and communicate expectations to the vendor
  • Conduct the on-site audit (for IT systems, Quality and IT representatives should participate)
  • Summarize findings with the vendor at the end of the audit
  • Document findings in an audit report and provide to the vendor for a response
  • Follow up on observations and document

The financial cost of, and risk associated with, software solutions has increased exponentially which means that it is imperative for organizations to understand what they are getting into before they sign on the dotted line.  The cost of a software or IT system blunder can be expensive in terms of resources, time and can make or break a life sciences company.  If you cannot demonstrate control, and therefore the integrity of your data, for systems supporting drug product administered to patients, a regulatory body may not grant approval for your product or could shut down manufacturing operations.  Your company owns the data and the responsibility even if it service is outsourced. 

Knowing your IT vendors gives you the knowledge to reduce the risks associated with the IT solutions in your life sciences company.  Without this knowledge, you are powerless to defend your risk assessment and risk mitigation strategy to regulatory agencies.

February 27, 2012

Know Your Team

Posted in Project Management tagged , , , , , , at 8:21 AM by Solutions2Projects, LLC

To get bored in IT project management is to give up.  No project is ever the same regardless of the technology being implemented.  Every project requires some form of a project team which means people are involved.  Even if you work with the same team over and over, there are always new inputs, influences and dynamics that make it a new situation requiring you to adapt as a project manager.

 This is perhaps the most challenging and rewarding part of project management that applies regardless of the industry and technology.  People’s lives are dynamic which means they are puzzles to be decoded on a regular basis throughout a project.  Just when you think you’ve got it figured out, someone has a baby, gets a new boss, is heartbroken, or finds a fabulous new hobby.  All of these things change the person’s priorities which means their interest and devotion to the project shifts and as project managers, we must respond accordingly to ensure that the project is successful. 

 It is important for me to get to know my project team members as people and not just as the resources on the project.  I like to get to know them as individuals and understand what is going on with them personally and professionally.  This provides me with a personal connection and a communication path to getting information regarding changes early in the process so as to better react in the event the changes impact the project.  This sounds manipulative but it’s not.  I am genuinely interested in the people on my projects.   This is evident in that I keep in touch with most project team members long after projects have ended regardless of how tough the project was. 

 And this is the challenge…as project managers we must be genuine in our interest in the resources on our project.  People can sense when you are only in it for the project or your own personal success.  The good news is that the investment in the time to get to know the resources on the project and understand their motivations and obstacles, is invaluable for all parties involved.  The team members feel heard and valued.  The project manager gathers information to effectively manage the team.  The project can move along towards success.    And that’s what it’s all about in the end.

February 6, 2012

Learning From My Mistakes

Posted in Project Management tagged , , , , at 11:51 AM by Solutions2Projects, LLC

I ran my second half marathon yesterday and based on my training, expected to come in at 2 hours and beat my first race time of 2:06.  Training times supported this expectation as two weeks prior to the race, I ran 12.6 miles at a 9:09 pace.  Reality didn’t match expectations and not only did I not reach my 2 hour goal, but I exceeded by first race time by 2 minutes.  It was a very disappointing experience and one I don’t intend to repeat in my next races.  Rather than looking at the experience as a complete failure (I held a personal pity party yesterday), I am choosing to learn from it.  The success here was that I finished despite having to run and walk the last 5 miles of the race. What I learned was the following:

  • Do not train beyond 10 miles prior to the race (I peaked too early)
  • Do not play soccer the Thursday before the race (my legs were tired)
  • Do not participate in any quad workout the week prior to the race (I had a softball coaching clinic with lots of knee bends the day before)
  • Keep the mileage up until a week before the race, then taper (I tapered too early)
  • Set my own pace and go with what is comfortable for me on that day, at that time
  • Running a race alone is tough for me and requires super mental toughness that I need to train for

 This is all valuable information and information I, personally, could only gain from failure.  Other experienced runners provided me with some guidance that I ignored thinking it wouldn’t apply to me as a seasoned athlete.  I may be a seasoned athlete but I am not a seasoned runner.   

 What is relevant here is that I made some fairly sizable tactical errors, still completed the race, and I plan to learn from the errors. 

 The same holds true with any projects I manage in that the results of a decision or series of decisions may not be as expected.  The first goal is to recover from the errors and the second goal is to learn from the mistakes.  I am constantly looking for ways to learn from previous experiences to improve processes and make things more efficient even if it was a total success.  Actually, I apply this to all aspects of my life as accepting mediocrity and the status quo is not acceptable. 

 No project ever goes according to plan.  Assumptions change.  Resources change.  Expectations change.  Situations change.  There will be mistakes, some more costly than others.  The important thing is to learn from the mistakes and apply the newfound wisdom to the next situation so as to avoid a disappointing repeat performance.

February 2, 2012

Nail Down the Details Before Signing Any Agreements

Posted in IT, Project Management tagged , , , , , , at 10:47 AM by Solutions2Projects, LLC

Negotiating contracts with software vendors is always a challenge.  The vendors won’t commit to resources until contracts are signed but without knowing the resources and their qualifications and availability, how do you know you will get what you want?

Vendors also want to defer detailed planning until after the agreements are signed.  Once again this is at odds with best practices from a planning perspective.  During the planning, a lot of details come to light that affect the final buying decision and overall timeline and budget.  Signing before nailing down these details generally ends up being very costly from an expectation and overall resource perspective. 

 A number of years ago I was working for a biotech company and we were selecting an ERP system.  A big name player was interested in breaking into the small-midsized life sciences market and saw our company as an opportunity to make this happen. Our budget wasn’t in line with their typical installs and they were touting a turnkey solution for life sciences.  I was skeptical.  They claimed the implementation and validation could be performed within our budget.  After detailed planning and working through the resource assumptions, it became very clear that they were shifting the responsibility for significant documentation tasks to our team (which was limited) which resulted in the reduced consulting fees.  Once we shifted the responsibility for those tasks back to their consulting team (to meet our timeline), the cost went through the roof and was no longer feasible.  This was not a surprise to us.  What was surprising was that they thought they would slip it by us. 

 In other cases, I’ve been brought into manage projects after agreements have been signed and quickly realize that my client made a series of assumptions (not documented) that were not aligned with what the vendor planned to deliver.  This tends to put me in the awkward and uncomfortable position of renegotiating the contract without much leverage as my client has already committed.  It often requires significant diplomacy on my part in that I have to demonstrate what was overlooked by them during the selection process.  Since they tend to have to defend their decisions and actions internally (politics!) and the scope or budget or timeline changes once detailed planning is performed, it can get pretty hairy. 

 If you are able to work through the details before signing the agreement, a lot of this messiness can be avoided or minimized.  I recommend performing the detailed planning prior to signing contracts, working with the vendor to create detailed statements of work to minimize surprises, and generating a project charter capturing the project elements.  The project charter is an internal document but I generally have the vendor consultants read and sign as well in order to hold them accountable as members of the project team. 

 And one of thing greatest benefits of going through this process is that you can learn very quickly how committed the software vendor is to the success of your project and to your company.  If a vendor is completely resistant to investing the time to generate a detailed statement of work based on detailed planning, this is a major red flag.  I would seriously reconsider doing business with that particular vendor.  Detailed planning sets everyone up for success.

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