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Review the gap analysis process and how to make it effective Think about how to choose the most appropriate method of gap analysis in a given situation CSV Gap Analysis: Case Study Gap Analysis in IT and for 21 CFR Part 11 Assessments What are practical and impractical corrective actions
ABB Eutech Process Solutions - 2
Why do a gap analysis? Seek reassurance that there are no serious gaps
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Gap Assessment
Gap Communication
Gap Management
Assessment
Communication
Evaluate different solutions and decide between them Carry out further investigation to arrive at a decision Involve all relevant competencies in decision making Estimate resources, timing and costs
Management
Gap = difference between actual state and desired state Know your desired state!
Desired
gap
Examples: URS
Actual
FDA/EU Regulations
National regulations HIPPA, Data Protection
Company procedures
gap Mandatory training requirements gap Industry best practice (e.g.GAMP, IEEE, ASTM)
Review of set of SOPs for an IT department Password and security requirements for computer systems Business Readiness Audit 21 CFR Part 11 compliance
Useful when.
Requirements are very clearly defined Gap Analysis will be repeated frequently Individuals dont have high degree of subject knowledge Narrow scope Goal is Assessment only
Auditor prepares a script which is a prompt for the areas to be covered Script typically includes examples of expected outcome Examples:
Internal Audit
Validation Package Audit
Useful when.
Baseline of compliance status is required Scope is broad Goal is Assessment and Communication
Chairman prepares script of areas to be covered and identifies required participants Examples:
Assessment of change of legislation which impacts a specific system (e.g. Data Protection, Clinical Trials Supply) 21 CFR Part 11 Assessment Reaction to Regulatory Warning Letters or Inspection Findings Reaction to quality problems
Used when
Narrow scope
Include recommendations for gap management Facilitate meetings with stakeholders to discuss options Evaluate which options are best for the business Evaluate risks associated with each option
Monitor actions
Record closure
Gap is closed at appropriate cost in an appropriate time frame with the buy in of all involved parties
The pitfalls
The IT Director of a Development Department asked for a review of the compliance status of Computer Systems in the department
Scope included three sites (two US, one European)
Site 1 SOP Review Review Policies Site 2 SOP Review Site 3 SOP Review
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Plan
Coaching
Deliverables
compares current practices against the defined criteria identifies existing compliance vulnerabilities in the systems reviewed prioritises the compliance issues that these gaps present to the business recommends how to solve the compliance issues identified
Auditor style gap assessment 6 days CSV policy and guidance review, audit planning and criteria definition 1 day Planning conference with audit team and client (telecon) 5 day audit and SOP review on each site
21CFR1 1
AGIT CSV
GA MP
Management M01 Current Organogram exists, and indicates independence of QA Function Written Validation Policy approved by senior management. Written record retention policy / interpretation Continuous Improvement/ self inspection processes are in place Records Ownership (details of who is responsible for the retained records) Evidence that QM practices are conducted to a recognized quality standard
58.195 211.22
58.35
11.100a
1D
CSV5
7.5.1
M02
1A
CSV4
CSV policy
M03 M04
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58.35d
O1
M05
58.190 c
11.10c
O6
M06
7A
CSV5
[F02]
M02
[F03]
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M07
[F04]
M01
Site 2
Site 3
Development Lifecycle
Operational Lifecycle
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Technical Controls Gap 1: Compliance vulnerabilities in policies and guidelines due to ambiguities, omissions with respect to 21 CFR Part 11 compliance, and uncontrolled roll out processes
Summary Outcome
Site 1 Management Compliance Planning
Gap 1
Site 2
Site 3
Gap 2
Gap 3
Development Lifecycle
Operational Lifecycle
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Technical Controls Gap 2: Weaknesses with SLA agreements internally and externally Gap 3: Inconsistencies and misunderstandings in complying with 21 CFR Part 11 policy
Summary Outcome
Site 1 Management Compliance Planning
Gap 1
Site 2
Site 3
Gap 2
Gap 3
Development Lifecycle
Operational Lifecycle
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Technical Controls Gap 4: Document management system used for submissions to FDA is not compliant with 21 CFR Part 11
Gap 4
Summary Outcome
Site 1 Management Compliance Planning
Gap 1
Site 2
Site 3
Gap 2
Gap 3
Development Lifecycle
Operational Lifecycle
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Gap 5
Gap 4
AGAINST
FOR Used by some companies High quality output through participation of variety of competent individuals Consistent interpretation when led by specialists Immediate and effective communication of gap Immediate assignment of actions Immediate cost/benefit evaluation
AGAINST Requires training of specialists to act as chairperson/ interpreter Resource intensive Requires more planning and co-ordination Progress appears to be slower
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Appoint person responsible for monitoring progress and documenting closure of actions Assign responsibility for finding a solution an appropriately qualified person Ensure all stakeholders are involved Agree deadlines Consider a mix of short term and long term solutions
Special funding
The solution would financially put the company out of business Ask a software supplier with only 5% of their sales volume in the Pharma sector to redesign their product immediately and at their own cost As a telecom service provider with 30,000 employees to train all its telecom engineers in GMP compliance Set deadlines for actions when there is
No budget No resource No buy-in from system owners No buy-in from senior management
Before an inspection
Assess gaps and formulate a plan for remediation If requested present the plan during the inspection Ensure actions are completed Ensure time lines are met
If you receive a
Identify the true extent of the gap or gaps Identify the underlying root cause Plan for remediation Report planned remediation to FDA
Software upgrades
Operating system Hardware platform Administration of users Software configuration
Use
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Authorisation of users
IT Team
Revalidation
Application Specialist
My personal opinion
GAP Analysis is a very effective tool for developing and maintaining compliance
Fax: +44 (0)1642 372166 Mob: +44 (0)7715 759197 e-mail: jennifer.methfessel@gb.abb.com