Corporate
Years 1999 - 2000 : SOLABS' Ignition was FDA's CFR 21, Part 11 regulations
In 1997, the Food and Drug Administration (FDA) issues regulations that provide criteria for acceptance by FDA of electronic records [...] as equivalent to paper records and handwritten signatures executed on paper. These regulations apply to all organizations operating under the scope of GxPs.
In 1999-2000, SOLABS' founders Philippe Gaudreau and An Phong Do are introduced to CFR 21 Part 11 by OMERC's personnel. Early on, they recognized CFR 21 Part 11 as an opportunity for GxP enterprises to diminish the complexity linked with the management of their documentation. The association with the OMERC brought to life SOLABS' Alibaba™ solution.
SOLABS' first regulated biopharmaceutical customer (operating under GLPs) was Dr. Fernand Labrie's Oncology & Molecular Endocrinology Research Center (OMERC) in 2000. OMERC is part of Laval University's Biomedical Research Center in Quebec City, namely the CRCHUQ. At the time OMERC employed more than 150 people involved in GLP activities.
Years 2001 - 2003 : R&D Years
Mr. An Phong Do directed SOLABS' development efforts towards the creation of:
- Alibaba™ release 1.0: It contains the PMA (Project Management Application - now known as Process Management Application) and AIR Console (Administration) modules.
- Alibaba™ release 2.0: It is re-engineered on a standard Web-based platform. It contains one additional module i.e., Uniform, used to manage document electronically.
- Alibaba™ release 2.3: It contains the Training module to manage training records electronically (sign-offs on SOPs, etc.).
Year 2004 : SOLABS was positioned as the highest ROI option on the market.
Alibaba™ became a mature technological solution. SOLABS developed a pure service approach to delivering Alibaba™ to bring recognized benefits to certain prestigious GxP-regulated customers on a wide geographical base. e.g., Merck & Co., Degussa Fine Chemicals, IPS Therapeutique, VITA Health Products, etc.
A critical mass of specialized employees was recruited to assist customers to move towards truly paperless environments, as far as GxP documentation and records were concerned.
SOLABS strived to establish itself as the highest ROI option on the market and achieved significant sales growth.
Year 2005 +: SOLABS strengthens its global strategic position.
SOLABS decided to adopt a pure service approach towards the supply of its software offering since traditional software industry models fail to provide economic company-wide access and secure early ROI through successful implementation.
By the end of 2006, SOLABS is clearly positioned as a leader in "Quality Management System".