Conformity provide specialist computer systems validation and compliance services and consultancy to the pharmaceutical and regulated life science industries.
We have unrivalled experience and expertise
in complying with international regulations on computer systems
validation and compliance. Our specialist areas include meeting
FDA and EU requirements,GAMP®, Data Integrity, and 21 CFR Part 11. Our consultancy
and services include: |
| • | Advising on risk-based approaches to computer system compliance and validation |
| • | Performing risk assessments |
| • | Providing consultancy and audits on Data Integrity |
| • | Developing computer systems validation and 21 CFR Part 11 compliance policies |
| • | Organizing for compliance – helping to define structures, roles, and responsibilities |
| • | Establishing effective and efficient
validation SOPs |
| • | Writing Validation Plans to achieve compliant systems |
| • | Managing validation projects |
| • | Auditing sites against regulatory
expectations for compliance, validation, |
| • | Performing supplier audits |
| • | Helping suppliers and users prepare for audits |
| • | Assessing the level of compliance
of organizations, facilities, or individual systems |
| • | Planning for remediation of legacy systems |
| • | Computer Systems Validation, GAMP®, and 21 CFR Part 11 training |
| • | Data Integrity Training |
| • | Helping supplier companies meet the requirements of regulated customers |