Pharma-Bio Serv's IT resources offer to our customers and prospects the most complete set of professional services in technology management, computer systems, automation and systems integration.  Considering the major impact of computerized systems as well as the new technologies used by world class and global organizations in highly competitive and regulated global markets, we have created diverse programs to satisfy the particular needs of your organization. 

The following are the core services for our group.  If your organization has a particular need for a service or system not included here, PHARMA SERV is willing to assist you to determine and assess the best solutions. So, feel free to contact us for more information.

• Automated Process Control Systems validation
• Bar coding and Data Collection Systems validation
• Development of Backup procedures
• Development of Change Control procedures
• Development of Configuration Management procedures
• Chromatography Computerized Systems validation (ie. Waters Millennium, Empower)
• Customer Relation Management (CRM) Systems validation (Siebel)
• Computer Integrated Manufacturing (CIM) systems validation
• Configuration Management Support
• Databases Consulting (Oracle,MS-SQL,MS-Access, DB2, Informix)
• Detailed Design Specifications (DDS)
• Disaster and Recovery Plans
• Enterprise Resources Planning (ERP) systems validation (SAP/R3, Oracle, PRISM, BPCS)
• Quality Management Software Programs (ie. Trackwise, IsoTrain)
• FDA 21 CFR Part 11 Assessment and GAP Analysis
• Financial Computerized Systems Validation
• Functional Requirements Specifications (FRS)
• Hardware / Software Evaluation and Configuration consulting
• Imaging and Content Management Systems validation
• In-house Audits
• Information Technology Infrastructure and Transfer Support
• Information Technology Validation Consulting
• Internet /WEB Systems validation (ie. Intranet, Extranet, B2B, E-commerce, M-business)
• IS Consulting and Systems Integration consulting
• Laboratory Information Management Systems (LIMS) validation (ie. PE, Beckman)
• Maintenance Systems Validation (ie. Maximo, MP2, CompuCal)
• Mobile Computing Systems validation
• Networking technologies and Communication Infrastructure validation
• Object Oriented Programming consulting (ie.Delphi, Visual Basic, Power Builder, C++)
• Process Control Systems validation (ie. PLC, DCS, I/O Devices, SCADA, Delta V)
• Radio Frequency based systems validation (Symbol, Intermec, Telxon)
• Relational Database Management (RDBMS) Systems validation (ie. Oracle, DB2, MS-Access, MS-SQL)
• Software System Development Life Cycle (SDLC) consulting
• System and Software Requirements Analysis
• Quality Records & Documentation Systems Validation (ie. Documentum)
• System Security Evaluations
• Testing Protocols development
• Training and Systems Review support
• Validation Master Plans development
• Vendor Audits
• Vendor and Technology Evaluation
• Version Control
• Wireless based systems validation
• IT Help Desk Support
• LAN Administration
• WAN Administration
• IT Center administration
• File Server administration
• Communications Administration (Data, Voice)
• IT infrastructure validation (switches, routers, wiring, etc.)
• IT Project Management

Inspection of Computerized Systems

Pharma-Bio Serv's personnel will help your organization in the following activities:

• Review Company Wide Policies and Quality Assurance Procedures
• Review Validation Plans and Protocols
• Review Requirement and Design Specifications
• Verify All Functions Were Included for Testing (Mapping)
• Review Testing for:
  • All Testing Steps to be Performed
  • Equipment and Methods to be Used
  • All Inputs are Listed
  • Expected Outputs and the Evaluation Criteria
• Review Documentation and Approvals
• Review Revalidation Criteria

Additionally, Pharma-Bio Serv will ensure that the following important elements of a validation program are included and considered as part of the process:

• Training of personnel on computer validation and guidelines on what computer products have to be validated.
• Definition of internal procedures for conducting the validation program, including standards for writing specifications, guidelines for validating process software, and forms for identifying and tracking safety hazards.
• Training/Requiring programmers to retain their testing documentation.
• Allocation of resources to conduct the validation program.
• Development of a validation program that focuses resources on critical areas.
• Communication between programmers and the QA personnel/functions that contribute to the development effort.
• Application of software validation and QA techniques early in the software development process.
• Use of documentation templates, measurement tools, and checklists where appropriate.
• QA reviews/audits of computer/software vendors.

While working with the validation protocols, the Pharma-Bio Serv personnel will consider and include the following information:

• Define what system is to be validated
• System Description
  • Identify all documents produced during the system development life cycle
  • Identify all signatures that are required
• Test Plan and Results
  • Identify all tangible outputs including code, user manual and maintenance documentation
• Ongoing Maintenance
  • documents, signatures, tests, improperly working code procedures, security, change control, etc.
• The expected content of an executed protocol document.
  • Scope
  • Purpose
  • Protocols
  • System description
    • Flow charts
    • Entity diagrams
    • User requirements
    • System requirements
  • Hardware description
    • Requirements
    • Design
  • Software description
    • Requirements
    • Design
  • Testing procedures
    • Methodology used and rationale
      • Test data
      • Test results
      • Limits tested
      • Conclusions
  • List of Standard Operating Procedures
    • System operation
    • Backup and Restore procedures
    • Configuration management
    • Change control
    • Version and release management
    • System building
    • Handling of source code
    • Revalidation procedure
    • Hardware maintenance procedure
    • Security Procedure
    • Training procedures
    • Raw data management
    • Software maintenance and enhancements
    • System crash and recovery, etc.
  • Documentation
  • System development documentation (hardware and software)
    • Requirements
    • Designs
    • Testing
    • Validation results (Verification)
  • Source Code Review
  • User's documentation/User manual
  • Standard operating procedures
• Validation Conclusions and Sign Off
• The Quality Assurance Program should fully document:
  • Change control/Configuration management
  • Audits, reviews, and walk-through
  • Backup, recovery, and security
  • In-process monitoring and statistics
  • Errors and incidents
  • Revalidation criteria