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.
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
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
Design Specification documents are maintained, detailing
the algorithm, scripts, libraries, and code for each Requirement
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.
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
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
- Validation Test Plan and Test Cases
- Validation Test Results
A formal change request and maintenance (CHARM) system is
implemented to manage future upgrades such as features enhancements and
The system is configuration specific and tracks the
changes introduced in various versions.
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.
All customized features specified by the customer are
designed, built, tested, and documented following the same life cycle
process described above.
21 CFR Part
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.