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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”.
QUALITY	TIME	EFFORT
„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

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