Validation Master Plan Suggestions$

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SoftwareCPR suggestions for a validation or Part 11 master plan are that it be a high-level plan not providing detailed document or protocol formats. Generally it is best if a master plan is a transient document.  It gets constructed for a specific need (e.g., constructing a new facility, addressing a systemic issue or new regulatory requirement).  Once the activities defined in the plan are complete and determined to have been effective, the plan becomes a historical record and is not maintained on an ongoing basis.  The corrective or preventive actions (e.g., procedures, training, auditing) implemented should then assure on an ongoing basis that compliance is maintained as new systems are added or existing systems are modified.

The first priority once the scope/inventory is established should be to establish formal procedural/administrative control (e.g., security, backup, data integrity checks, date/time controls, monitoring,…) over applications already in use that have gaps in these areas.

Some topics to consider addressing are:

” Introduction, Purpose, and Background
” Scope/Software Inventory (include as attachment or indicate will be developed)
” Resources, Responsibilities – and plan approvals
” Approach
— Legacy software
— New Systems
— Types of software
— PLCs/automated equipment
— Configurable applications (e.g., spreadsheets, databases)
— IT systems (e.g., doc control, compliant handling, mrp, erp, …)
o Priorities
o Standards: documentation, procedures, handling functionality deficiencies (e.g., acceptability of interim manual measures to protect data integrity).

— Elements of Validation such as
— Requirements analysis — Design
— Coding (if relevant)
— Test plans/protocol
— Test execution and results
— Coverage/tracebility — Installation qualification
— Configuration/change/release management
— User training
— Backup and recovery
— Security
— Administration (if relevant)
— Monitoring

— Schedule – consider several stages where

o Stage 1 is planning, training, development of policy procedure and Part 11 interpretations , and small immediate corrective actions
o Stage 2 is corrective action for selected applications of each type to serve as prototypes (preferable high exposure applications)
o Stage 3 is completion for all remaining applications
o Stage 4 is initial summary and closure
o Stage 5 is longer term enhancement or replacement of systems that can not easily be made Part 11 compliant (if any)

A detailed schedule could be maintained separately from the plan for ease of modification.

SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering:  TBD

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Being Agile & Yet Compliant (Public or Private)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: March 7 & 28, 2024

Virtual via Zoom

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This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD

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