QUALITY ASSURANCE

Quality Policy

Our Quality system ensures quality in everything we do and enables us to achieve our strategic goals and objectives. Our commitment is demonstrated by:

  • Consistently meeting or exceeding our customer quality requirements.
  • Delivering services with Quality, integrity, speed and Passion.
  • To pursue excellence in all aspects of End to End Analytical services.
  • Continuous improvement of our systems and processes.
  • Ensure proper training of our team so as to better serve our customers.
  • To assure that each Perfomics employee recognizes the importance of their role in complying with our Quality management system.

Quality Assurance

PERFOMICS Labs provides timely communications and structured method development for more rugged methods and improved ISR results. Our objective is to use our technical expertise to help you reduce your overall time in bringing new medicines to market. We serve the pharmaceutical, biopharmaceutical, and biotechnical industry by combining advanced analytical instrumentation with superior technical expertise.

QUALITY ASSURANCE UNIT:

Our quality assurance programs exceed minimum accreditation standards to help ensure high accuracy and confidence in results. Stringent process control guidelines are incorporated along with precision automation and specimen tracking.
Standardized methodologies, reference intervals, instrumentation and quality controls are used to minimize variability and increase accuracy of results.
Perfomics Labs complies with applicable guidelines for Good Clinical Practice (GCP), as well as guidelines for Good Laboratory Practice (GLP) where appropriate. In addition, our databases are compliant with the Code of Federal Regulations Title 21 Part 11, which applies to electronic records.
Our global quality assurance strategy is simple: provide timely, proactive and dependable service each and every time while ensuring the highest standards possible.
Our quality assurance programs exceed minimum accreditation standards to help ensure high accuracy and confidence in results, and stringent process control guidelines are incorporated along with precision automation and specimen tracking.

  • GCP and GLP compliance where appropriate
  • Global QA and analytical proficiency programs
  • Computerized systems are validated and 21 CFR Part 11 compliant
  • Processes governed by global SOPs

In addition to undergoing inspections by state, federal and other accredited organizations, daily monitoring of results, internal proficiency challenges and external programs serve as established quality assurance procedures at Perfomics Labs. We also invest significant time and resources in our employee training and process improvement programs using proven methodologies.

Our comprehensive quality system includes:
  • Standard operating procedures (SOPs)
  • Employee training program (regulatory and job specific)
  • Audit program
  • Change control process
  • Process for corrective actions and preventive actions
  • Quality metrics program
  • Quality council
GLP COMPLIANCE:

Perfomics Labs conducts all projects within the guidelines of GLP principles.
The QAU performs the following functions irrespective of the regulatory status of the project:

  • Active phase inspections of all studies
  • Study-specific inspections
  • Process-based audits, which include audits of controls in place that ensure SOPs are constantly followed
  • Facility audits.

All studies are inspected against an extensive set of perfomics Labs’ or client-specific standard operating procedures (SOPs) to ensure consistent and reproducible data. SOPs are continually evaluated and updated to reflect evolving technology.

TRAINING PROGRAME:

Training of QAU personnel encompasses a comprehensive program to give an auditor a sound regulatory base.
The QAU personnel actively participate in the following:

  • Continuous laboratory-sponsored training to ensure auditors are current on evolving procedures and technologies
  • Attendance at various external courses, seminars, and conferences to further enhance education by outside QAU professionals
  • Training for management and technical staff in compliance areas such as Good Laboratory Practice Regulations, computer validation, and 21 CFR Part 11 regulations.
  • Personnel who do not participate in GLP-related studies receive extensive training specific for their specialty, as well.