|
|
Introduction
Celebrating our 2nd decade, Validation Plus, Inc. (VPI) has been providing compliance and validation consulting services to the medical device, pharmaceutical, biotechnology, and tissue/organ banks industries since 1995. Validation Plus performs projects successfully, identifies and recommends solutions to your problems. The services of Validation Plus include all phases of project management from concept design to FDA approval.
- The services of Validation Plus include all phases of your project from concept design to FDA approval. Our Senior and Principal Consultants come from leading medical device, pharmaceutical, and biotechnology firms. Our Senior Consultants have ten or more years of experience and our Principal Consultants have twenty or more years of experience. Validation Plus Senior and Principal Consultants will provide you with answers to ensure a successful project, to ensure that equipment will work as expected and to identify warning signs of project failure, and what to do to compensate.
- Validation Plus is a company with one goal, Your Satisfaction. Our Experience, Cost Benefits to our customers, and Consistency have resulted in numerous letters of recommendation from pharmaceutical, medical device, biotechnology firms, and tissue/organ banks. Validation Plus focuses not only to help build a successful project, but to identify and recommend alternative solutions.
How Do You Factor Quality Into Your Consulting Decision?
When selecting a contracting or consulting firm, how does quality figure into your decision? A famous car manufacturer's slogan was, "Quality is Job 1". Is Quality of primary importance to you? If so, should quality be of primary importance to your contracting or consulting firm?
Some companies choose contracting or consulting firms solely based on price. When you chose your last home, your last car, or even your last home repairman did you choose solely based on price? Did you choose the cheapest house to buy? (That would be a house in the worst neighborhood right?) The cheapest car used to be a Yugo. Are they still around? Know anyone who still says that they are great cars? Are they even in business anymore? How about the last time you chose the cheapest plumber or roofer? Did he/she do the job right the first time? Is it still fixed? Are you still pleased with their work?
As an employee of a pharmaceutical, biotechnology, medical device firm, or tissue/organ bank, you are responsible for choosing the best way to use the company's resources. Should you choose the "low price leader"? If you do, will you regret this decision later?
Considerations in selecting a validation consulting firm should include the following:
- Due diligence on the firm. Review the expertise of the validation consulting firm and the time they have been engaged in business in the industry.
- Analyze the quality the validation consulting firm has built into your proposal. Does it meet or exceed Sustainable Compliance standards? Do you have confidence that the firm will exceed your organization Quality Assurance standards and exceed the FDA's requirements?
- Review the validation consulting firm's letters of recommendation. Their past commitment to quality is a good indication of their future commitment to quality.
- Assess the years of experience and skill sets of the consultants. Qualifying the consultants to ensure their expertise in performing the task(s) can provide superior value and cost savings.
- Assess the recommendations made by the validation consulting firm do they add value to the tasks you need them to perform?
|
|
|
|