Listed are some projects that Visentic Solutions have participated. Due to confidentiality agreement, no client’s name is stated.

Computerized System Validation
Title: 

~ S$500 million greenfield biotechnology plant

Achievements:

  • Revamped and modularized validation strategy of ~10,000 I/O DCS.
  • Reduced documentation development and execution up to 50 - 90%.

Title: 

Established pharmaceutical plant for bulk dosage solid dosage form

Achievements:

  • Strategized and developed validation master plan and change control procedure for laboratory system qualification.
  • Optimize qualification effort through risk-based approach reducing qualification steps by up to 50%.

Title: 

Established biotechnology plant

Achievements:

  • Fast tracked project completed in 2 months without incidents upon release for use.
  • Reduced validation execution effort by running SQL query to compare data attributes of documents migrated.
  • Improved quality of migration by eliminating incomplete mapping to be manually processed after migration.

Title: 

Established non-clinical research facility

Achievements:

  • Strategized and developed verification method of study data based on SENDIG requirements.
  • Successfully completed validation of software solution and verification of 2 non-clinical studies in 6 months.

Quality Assurance
Title: 

~ S$300 million Greenfield pharmaceutical plant for bulk solid dosage form plant

Achievements:

  • Strategized commissioning and qualification of ~300 systems plant wide with 1 unified approach.
  • Completed qualification of ~200 critical systems based on risk-based approach with 2 headcounts.
  • Passed HSA, FDA and PMDA inspections.

Title: 

Oversea local biotechnology plant

Achievements:

  • Site's consensus of compliance weakness achieved via open in-depth interaction with end user.
  • Practical solutions outcome based on process inputs and industrial proven methods.

Title: 

Oversea established medical device manufacturing plant

Achievements:

  • Audit facilitation mapping between multisite SOP and regulation requirements.
  • Traceable and quantifiable compliance review inputs presented in a streamline structured manner.

Title: 

Established research facility

Achievements:

  • Comprehensive data integrity assessment covering site, process, system and data.

Training
Biopharm Asia Convention 2012
  • Workshop on Automation strategies for improved GMP compliance.
Basic CSV
  • Standard classroom training for system suppliers prior to test execution (English / 中文).
  • Standard classroom training for end user of an oversea local biotechnology plant during project phase (English / 中文).
Site Specific DI
  • Customized classroom training for an oversea local biotechnology plant (中文).