DRP Documentation and continuity
Disaster Recovery Plans
When something fails, your operation knows what to do. A power outage, ransomware or a server failure can stop your operation in seconds. The difference between a disruption and a crisis is preparation. We design recovery plans with clear priorities (RTO and RPO), defined roles and real testing.
Signals
When do you need it?
- You have backups, but never tested a restoreAnd you don't know how long it would take to get back up and running.
- RTO and RPO aren't definedNor which systems are recovered first.
- An auditor asked about continuityAnnex 11 §16 requires arrangements to keep critical processes running.
- You suffered an incidentAnd the response relied on a few people improvising.
Approach
Being prepared is also protecting operations
A recovery plan isn't a document to file away in a drawer. It starts with understanding which processes are critical, how long they can be down and how much data you can afford to lose. The strategy is designed from there, not the other way around.
We document who does what, in what order and how it's communicated. Then we test it with drills, because a plan that has never been tested is just a hypothesis.
A plan that has never been tested is just a hypothesis.
How we do it
Service stages
- 01RisksThreats, vulnerabilities and disruption scenarios.
- 02BIACritical processes, RTO and RPO.
- 03StrategyBackup, replication, alternate sites and suppliers.
- 04PlanProcedures, roles, escalation and communication.
- 05TestingDrills, lessons learned and updates.
Regulatory framework
What the regulations require, point by point.
These are the references we work with for this service. We apply the ones that fit your market and your type of product.
EU GMP EudraLex Volume 4
- Annex 11 §7Data storage: regular backups and verification of restoration.
- Annex 11 §16Business continuity for systems supporting critical processes.
FDA United States
- 21 CFR 211.68(b)Data backup copies and controls over automated systems.
- 21 CFR Part 11Protection of electronic records throughout their retention period.
ISO Continuity and security
- ISO 22301Business continuity management systems.
- ISO/IEC 27031ICT readiness for business continuity.
- ISO/IEC 27001Information security controls and resilience.
PIC/S Inspectorates
- PI 011-3Continuity, backup and recovery of GxP computerized systems.
Deliverables
What you get.
Inspection-ready documentation, fully traceable and in your format. And a team trained to maintain it.
- Risk and vulnerability assessmentThreats, likelihood and impact on critical operations.
- Business impact analysis (BIA)Critical processes with their RTO and RPO.
- Recovery strategiesTechnology, operational and infrastructure alternatives.
- Documented Recovery PlanProcedures, roles, escalation and contacts.
- Crisis communication planInternal teams, clients, suppliers and authorities.
- Testing and drill programExercises, lessons learned and plan updates.
FAQ
What clients ask before we start
What's the difference between a DRP and a BCP?
The BCP (business continuity plan) covers the whole organization. The DRP focuses on recovering the technology and data that support it. We work on both in an integrated way.
What are RTO and RPO?
RTO is the maximum time a process can be down. RPO is the maximum amount of data you can lose, measured in time. They are the foundation of the plan's design.
Do you implement the backup infrastructure?
We design and plan the strategy together with your IT team and suppliers, and verify through testing that it works as expected.
Works well with
Related services
-
QA·IT
IT quality management
Without an inventory, criticality and QA IT policies, every validation starts from scratch.- GxP inventory
- GAMP 5
- PIC/S PI 011-3
-
CSV
System validation (CSV)
LIMS, ERP, MES, SCADA or QMS that must prove they do what they claim.- GAMP 5 Second Edition
- 21 CFR Part 11
- EU GMP Annex 11
-
SOP
SOP development
SOPs written for compliance that nobody reads, understands or follows.- 21 CFR 211.100
- EU GMP Chapter 4
- ICH Q10
Next step
Be ready for your next
regulatory challenge.
Tell us what you need to validate, qualify or document. In the first conversation we get to know your operation and tell you how we would approach it.