GMP-compliant update of your documentation after changes
Service area
Retrofit & obselescence management
Lifecycle
Modernization
Documentation update at a glance
Updating your documentation when minor system changes are made
GMP compliance
Documentation according to regulatory requirements
Audit readiness
Current documentation for inspections
Documentation in SKAN quality
SKAN’s documentation is recognized by global authorities
Workload reduction for internal teams
Support for updating documentation
Manufacturer expertise
Updates carried out by an experienced engineering team
Flexible models
Individual updates or update packages
Defined response time
Standard, urgent, or top priority
Transparent scope
Clearly defined number of affected documents
Application
Comprehensive, transparent documentation
For existing systems
The documentation update service covers minor changes such as component replacements, layout modifications, or control system updates without requiring software changes.
For audit and inspection preparation
With documentation updates, we support your internal teams in preparing for authority inspections. We provide you with complete, up-to-date documentation at all times.
Process
Structured process to update technical documentation
1
Inquiry and preliminary clarification
Entry of the inquiry via e-mail or telephone, identification of the isolator, and coordination of the required response time.
2
Information gathering
Review of your indiviual change requests, change descriptions, and relevant references.
3
Documentation analysis
Check which documents are affected by the change and to what extent adjustments are required.
4
Updating of documents
Revision of all relevant documents in accordance with the defined change.
5
Review and approval
Internal review and formal approval of the updated documentation, followed by provision for further use and archiving.
Service highlights
Safety and transparency with technical changes
Regulatory compliance
The documentation update ensures that your individual changes are documented clearly and are traceable from a regulatory viewpoint. SKAN documents are recognized by regulatory authorities worldwide.
Efficient implementation
Through clearly defined packages and response times, the effort for documentation adjustments can be managed in a plannable and efficient manner.
Relief during peak periods
Support from our documentation service can relieve your internal teams during peak workloads, allowing you to focus on other priorities.
