Part 11 & Validation Certificate

Makromed follows a classical software development life cycle model to develop its InfoSuite software products. The following documents are generated as a result of this activity, and together provide adequate validation of the software.

Software QA Plan (SQAP)

Formal QA plan for InfoSuite software is written per ISO 9000-3 guidelines. The plan addresses the following major issues:

  • Project Organization and Responsibilities
  • Resources and Schedule
  • Project Phases and their Initiation Criteria
  • Inter-relations between Phases
  • Deliverables from each Phase
  • Review Requirements for each Phase

Software Requirement Specification (SRS)

Formal requirements specification for InfoSuite software are written per the IEEE standard and ISO 9000-3 guidelines. These are divided in five specific sections:

  • General Requirements
  • Database Requirements
  • User Interface Requirements
  • Functionality Requirements
  • Security Requirements

Software Design Documents

Design Specification documents are maintained, detailing the algorithm, scripts, libraries, and code for each Requirement Specification.

Test Documents

All testing is done following the standard software validation SOP maintained at Makromed. This requires that tests be done by independent personnel according to the formal test plan and cases that are reviewed and approved. Test results are also formally reviewed. Tests are conducted at unit, integration and system level.

Traceability

A sound software development process requires that the traceability between various software elements be maintained. Makromed maintains the following traceability matrix:

  • Requirements vs. Design
  • Requirements vs. Validation Tests

Reviews

Formal reviews are required at all major phases of software development process. Engineering and quality reviews of the following are documented:

  • Quality Plan
  • Requirements Specifications
  • Design
  • Validation Test Plan and Test Cases
  • Validation Test Results

Software Maintenance

A formal change request and maintenance (CHARM) system is implemented to manage future upgrades such as features enhancements and bug fixing.

Configuration Management

The system is configuration specific and tracks the changes introduced in various versions.

On-Site Validation

Makromed provides formal data record forms with InfoSuite software to help perform and document the installation qualification (IQ) and operation qualification (OQ) of the software on the customer's computing environment.

Customization

All customized features specified by the customer are designed, built, tested, and documented following the same life cycle process described above.

21 CFR Part 11 Compliance

InfoSuite software has the enhanced security and audit trail features that comply with the electronic signature and records requirements of the 21 CFR Part 11 regulation