Records Management and Compliance Software for the Pharmaceutical and Life Science Industry

Competing in the highly regulated pharmaceutical and life science industry presents significant challenges for life science and pharmaceutical businesses. A key part of this challenge is to manage the large volume of records which must be kept to meet compliance obligations across all areas of business activity.

With DCS records management and compliance software, pharmaceutical and life science companies can deploy a document compliance strategy which ensures the integrity, confidentiality and accessibility of business records, while controlling costs with greater automation of records retention.

Our solutions help you automate, control and monitor compliance with:
• SOP review and approval
• CAPA
• Deviations, complaints and audits

The DCS solutions help minimise compliance risk by automatically generating secure, auditable and traceable records and enabling implementation of best practice frameworks such as the internationally recognised ISO 15489 standard.

Consultancy and technology solutions for ISO 15489 compliance

DCS can help companies in the pharmaceutical and life science industry achieve and maintain compliance with ISO 15489 and similar standards such as MoReq or DIRKS. We offer tailored consultancy packages delivered by CDIA+ accredited consultants who provide a range of assessment and external audit services.

DCS support these services with specially designed ISO 15489 compliance software to help pharmaceutical and life science companies implement standards quickly and cost-effectively. DCS records management software enables easy implementation of records file plans and automates records declaration and retention processes, reducing both risk and cost.

Email records and compliance

With an increasing amount of business information entering and leaving companies via email in the pharmaceutical and life science industry, the need for greater compliance management in this area becomes more acute. In this area, DCS records management and compliance software solutions enable automatic centralised archiving of all inbound and outbound fax and email communications, as well as automatic monitoring of content against compliance policies.

Our solutions also facilitate ediscovery by enabling easier searching of email and document content across company networks and through the ability to generate searchable histories of all incoming, outgoing and deleted emails, documents and faxes.

Legal admissibility and audit trails

To help pharmaceutical and life science companies ensure the legal admissibility of their electronic documents and records, DCS FileStore records management software comprises in-built audit trail logging. The audit trail logging module helps ensure the integrity of electronic records to BS BIP 0008 standard by allowing companies to demonstrate all actions which have been performed on files throughout their lifecycle.

Data protection

To ensure compliant retention of private personal data held by human resources or marketing departments, FileStore records management and compliance software protects data with high levels of user access control. Managers can compartmentalise information so that users gain audited access only to the documents required to complete their tasks. Automated records retention monitoring helps ensure data are not retained longer than prescribed time frames.

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