Medical devices, pharma and laboratory: every step traceably evidenced
Whoever manufactures medical devices or medicines or runs a laboratory must be able to show who carried out which step and when. CaRD Plan steers such procedures as a team and delivers the sequence as a building block of your evidence – without replacing your validation.
Request a demoTypical procedures
Wherever many people have to complete and evidence steps in a fixed order, the procedure becomes a template and every execution its own plan.
- Qualification of equipment and instruments (IQ, OQ, PQ) and validation runs
- Implementing changes according to your change control
- Technology transfer, site transfer and laboratory relocation
- Introducing or replacing systems such as ERP, MES or LIMS
Evidenced, not just planned
Every action is in the history with person and time; comments and attachments sit on the step. A step can only be forced despite open predecessors with a reason – and the reason is part of the evidence, too. At the end there are the closing report as PDF and the project archive with the complete history.
Who may do what
Roles for planners, executors, viewers and administrators, access grants per project or plan, sign-in with local accounts or Microsoft Entra ID. Operated by CaRD in Germany or in your own environment – without telemetry and without licence checks.
What CaRD Plan does not replace
CaRD Plan is not a quality management or document management system and does not replace a validation for your intended use. Which requirements apply to your use – for example from 21 CFR Part 11 or EU GMP Annex 11 – and how you meet them is assessed in your quality management system.
Frequently asked questions
Is CaRD Plan suitable for FDA-regulated companies?
CaRD Plan records every step with person, time and comment and thereby delivers a traceable sequence as a building block of your documentation. It does not replace a validation for your intended use – for example under 21 CFR Part 11; you assess those requirements within your quality management system.
Where is the data stored?
Either with CaRD in Germany or in your own environment – Windows Server, Linux, Docker or your cloud. CaRD Plan needs a PostgreSQL database and in operation talks only to what you connect yourself.
How does this relate to management of change?
You assess and approve the change itself in your quality management or PLM system. CaRD Plan plans and steers the implementation steps across all departments and evidences each of them.
More use cases
Management of Change
Implement product and process changes in a structured way: steps, owners and approvals in one plan, every step recorded with person and time.
Learn more →Product development process
Product development from idea to production release: phases and quality gates as a template, tasks per department, live feedback and evidence for every gate.
Learn more →ERP cutover planning
ERP go-live without spreadsheet chaos: cutover plan as a template, rehearsals, live board and closing report – for SAP S/4HANA, Dynamics 365 or JD Edwards.
Learn more →Acceptance and test plans
Factory and site acceptance, software tests and validation runs as a plan: test steps in a fixed order, findings on the step, the protocol as PDF.
Learn more →Maintenance plans and shutdowns
Maintenance, shutdowns and overhauls of complex products and plants: the procedure as a template, teams live, every step recorded with person and time.
Learn more →System replacement and harmonisation
Move sites and companies onto one system, one after another: the procedure as a template, every wave its own plan, findings carried into the next one.
Learn more →Machinery and plant engineering
Commissioning, test sequences and acceptance at the customer as a plan: test steps in a fixed order, readings as findings, report-back straight from the phone.
Learn more →Aviation, energy, transport
Retrofits, product changes and system changeovers in safety-critical industries: exact order, Force only with a reason, complete history.
Learn more →Quality management
Sampling, inspections, releases and audits following the same procedure every time: planned as a template, done as a team, every step evidenced.
Learn more →Food and beverage
Product changeovers with allergen cleaning, HACCP checks, traceability tests and audit preparation as a plan – every step evidenced with person and time.
Learn more →See your own procedure in CaRD Plan
Tell us briefly what it is about – in 30 minutes we show you what the plan looks like.
CaRD Gesellschaft für EDV-Beratung mbH
Gutenbergring 2 · 69168 Wiesloch, Germany
Phone +49 6222 9256-0 · E-mail info@card.de