SpeeDEV and GMP Compliance

SpeeDEV – Automated process for GMP Compliance

The SpeeDEV suite has been developed to address stringent process and audit trail requirements to cater to every facet of the GMP regulation.


  21 CFR Part 11 Compliant

  Browser based User Interface

  Enables QS/GMP regulation compliance


The GMP regulation stipulates that software vendors establish “documented evidence which provides a high degree of assurance that a specific process consistently produces a product which meets all it’s predetermined specification and quality attributes”.




Having an enforceable quality process for both requirements and defect management

Create accountability for all actions to realise traceable quality improvements

Generate audit tracking reports instantly

Single source of requirements and defects (issues)

Store results of all quality reviews in a single system

Instantly generate reports for quality review and FDA audit purposes

Save man hours required to manually create reports from disconnected pieces of information

Enforcing the quality process is handled by the system, freeing your efforts to be expended on revenue generating activities

Process Compliance

“The QS regulation requires that each manufacturer have a formally established and documented quality system.”  [FDA Quality Systems].  “Records of validation activities and results must be maintained” [820.75(a)].

Improve process adherence

 Best practices library, including the industry recommended V-Model Process

 Setup quality gates

 Enforce process and approval rules

Improve process audit

 Metrics on process and activities

 Validation reports of activities and results

 Display graphical process flow

Requirements Management

“Make design controls an integral part of development.  Discrepancies between the proposed designs and requirements should be corrected earlier in the development process.”  [FDA Design Control Guidance 21 CFR 820]

Improve requirements management

 Provide a “mechanism to address incomplete, ambiguous, or conflicting requirements” [Title 21,820.30c]

  Requirement scrubbing, defining and approval

 Automate Traceability between requirements, test cases and defects [Quality System Regulation [Title 21,820.30c]

 Track updates and revisions to requirements and issues creating a rich audit trail, and metrics for analysis

Improve process audit

 Ad hoc reporting on all quality, process, and audit data to meet FDA audit requirements

  Attach documents and URLs so that all pertinent information to an issue is easily available

Improve productivity

 Web based access for globally distributed teams

 Create unlimited custom fields

Defect and Quality Management

“The purpose of the corrective and preventative action subsystem is to collect, analyse, identify and investigate product and quality problems, and take appropriate and effective action.”  [FDA Guide to inspection of Quality Systems].

Improve defects management

 Track Corrective and Preventative Actions (CAPA) through a single system

  Single source issues/defect management

 Provide traceability from the CAPA to the appropriate design specifications

Improve productivity

  Users customise their view of the data

 Web based access for globally distributed teams

Improve quality of service to your customer base

 Empower customers to be members of your quality program

 Enable customers to track issues through the system

  Define escalation and notification rules to ensure that issues are dealt with in a timely manner

Improve productivity

 Ad hoc reporting on all quality, process, and audit data to meet FDA audit requirements

 Attach documents and URLs so that all pertinent information to an issue is easily available